Trial Outcomes & Findings for Research and Innovation to Stop E-cigarette/Vaping in Young Adults (NCT NCT04974580)
NCT ID: NCT04974580
Last Updated: 2024-07-29
Results Overview
Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
508 participants
Primary outcome timeframe
3 months after the first coaching call (occurred at baseline)
Results posted on
2024-07-29
Participant Flow
Participant milestones
| Measure |
CoachingOnlyArm
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
134
|
126
|
126
|
122
|
|
Overall Study
COMPLETED
|
101
|
87
|
96
|
93
|
|
Overall Study
NOT COMPLETED
|
33
|
39
|
30
|
29
|
Reasons for withdrawal
| Measure |
CoachingOnlyArm
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
33
|
39
|
30
|
29
|
Baseline Characteristics
Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
Baseline characteristics by cohort
| Measure |
CoachingOnlyArm
n=134 Participants
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=126 Participants
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=126 Participants
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=122 Participants
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age Category · 18-21 years old
|
76 Participants
n=134 Participants
|
80 Participants
n=126 Participants
|
71 Participants
n=126 Participants
|
63 Participants
n=122 Participants
|
290 Participants
n=508 Participants
|
|
Age, Customized
Age Category · 22-24 years old
|
58 Participants
n=134 Participants
|
46 Participants
n=126 Participants
|
55 Participants
n=126 Participants
|
59 Participants
n=122 Participants
|
218 Participants
n=508 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
97 Participants
n=134 Participants
|
92 Participants
n=126 Participants
|
85 Participants
n=126 Participants
|
88 Participants
n=122 Participants
|
362 Participants
n=508 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
34 Participants
n=134 Participants
|
30 Participants
n=126 Participants
|
34 Participants
n=126 Participants
|
28 Participants
n=122 Participants
|
126 Participants
n=508 Participants
|
|
Sex/Gender, Customized
Gender · Transgender female
|
0 Participants
n=134 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=126 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=508 Participants
|
|
Sex/Gender, Customized
Gender · Transgender male
|
2 Participants
n=134 Participants
|
2 Participants
n=126 Participants
|
3 Participants
n=126 Participants
|
3 Participants
n=122 Participants
|
10 Participants
n=508 Participants
|
|
Sex/Gender, Customized
Gender · Other identity
|
1 Participants
n=134 Participants
|
2 Participants
n=126 Participants
|
4 Participants
n=126 Participants
|
2 Participants
n=122 Participants
|
9 Participants
n=508 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
84 Participants
n=134 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
86 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
92 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
88 Participants
n=121 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
350 Participants
n=507 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black / African
|
11 Participants
n=134 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
12 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
13 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
7 Participants
n=121 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
43 Participants
n=507 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic / Latinx
|
19 Participants
n=134 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
7 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
7 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
15 Participants
n=121 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
48 Participants
n=507 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
|
Race/Ethnicity, Customized
Race/Ethnicity · All others
|
20 Participants
n=134 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
21 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
14 Participants
n=126 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
11 Participants
n=121 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
66 Participants
n=507 Participants • Missing race/ethnicity data on one participant (due to not answering a question on the baseline survey).
|
|
Daily E-cigarette use, baseline
Daily E-cigarette use at baseline
|
99 Participants
n=134 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
97 Participants
n=126 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
96 Participants
n=125 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
103 Participants
n=122 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
395 Participants
n=507 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
|
Daily E-cigarette use, baseline
Less than daily use at baseline
|
35 Participants
n=134 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
29 Participants
n=126 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
29 Participants
n=125 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
19 Participants
n=122 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
112 Participants
n=507 Participants • Missing data on one participant (due to not answering a question on the baseline survey).
|
|
E-cigarette use 30+ times per day
Use 30+ times per day
|
38 Participants
n=132 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
48 Participants
n=121 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
46 Participants
n=120 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
51 Participants
n=119 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
183 Participants
n=492 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
|
E-cigarette use 30+ times per day
Use <30 times per day
|
94 Participants
n=132 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
73 Participants
n=121 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
74 Participants
n=120 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
68 Participants
n=119 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
309 Participants
n=492 Participants • Missing data on 16 participants (due to not answering a question on the baseline survey).
|
PRIMARY outcome
Timeframe: 3 months after the first coaching call (occurred at baseline)Population: All participants who were fully enrolled at baseline are included. Those missing outcome data are imputed as not abstinent.
Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.
Outcome measures
| Measure |
CoachingOnlyArm
n=134 Participants
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=126 Participants
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=126 Participants
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=122 Participants
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
7-day Point Prevalence Vaping Abstinence
|
55 Participants
|
54 Participants
|
61 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Assessed 3 months after study enrollmentPopulation: All participants who were fully enrolled at baseline are included. Those missing outcome data are imputed as not abstinent.
Self-reported 30-day point prevalence vaping abstinence
Outcome measures
| Measure |
CoachingOnlyArm
n=134 Participants
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=126 Participants
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=126 Participants
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=122 Participants
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
Vaping Abstinence
|
46 Participants
|
45 Participants
|
52 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Assessed 3 months after study enrollmentPopulation: Participants who were not 7 day point prevalence abstinent at the 3-month follow up survey and had complete PROMIS-E data at both baseline and the 3-month follow up survey.
Self-reported e-cigarette dependence using the Patient Reported Outcomes Measurement Information System - E-cigarettes (PROMIS-E) questionnaire. Minimum t-score 0, maximum t-score 100. Larger scores indicate greater dependence.
Outcome measures
| Measure |
CoachingOnlyArm
n=38 Participants
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=29 Participants
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=33 Participants
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=28 Participants
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
E-cigarette Dependence - PROMIS-E
|
-5.5 change in t-score
Standard Deviation 10.3
|
-2.6 change in t-score
Standard Deviation 7.8
|
-6.5 change in t-score
Standard Deviation 10.5
|
-7.3 change in t-score
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Assessed 3 months after study enrollmentPopulation: Participants who were not 7-day point prevalence abstinent at the 3-month survey and completed all questions as required by the PSU dependence questionnaire
Self-reported e-cigarette dependence using the Penn State E-cigarette Dependence Index. The total score ranges from 0-20, with higher values indicating greater dependence.
Outcome measures
| Measure |
CoachingOnlyArm
n=26 Participants
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=16 Participants
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=22 Participants
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=15 Participants
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
E-cigarette Dependence - Penn State E-cigarette Dependence Index
Low dependence (4-8)
|
10 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
E-cigarette Dependence - Penn State E-cigarette Dependence Index
Medium dependence (9-12)
|
8 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
|
E-cigarette Dependence - Penn State E-cigarette Dependence Index
Not dependent (0-3)
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
E-cigarette Dependence - Penn State E-cigarette Dependence Index
High dependence (13+
|
7 Participants
|
11 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 months after study enrollmentPopulation: Participants who were not 7-day point prevalence abstinent at the 3-month survey and were not missing data on number of days vaped in the past 30 on either the 3-month or baseline survey.
Self-reported e-cigarette use frequency in the last 30 days. Measured at baseline and 3 months after study enrollment and calculated as the change between these two time points (3 months - baseline).
Outcome measures
| Measure |
CoachingOnlyArm
n=44 Participants
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=31 Participants
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=34 Participants
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=30 Participants
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
Changes in E-cigarette Use Frequency
|
-7.9 Vaping days past month
Standard Deviation 9.0
|
-6.9 Vaping days past month
Standard Deviation 9.3
|
-9.3 Vaping days past month
Standard Deviation 9.9
|
-5.5 Vaping days past month
Standard Deviation 10.0
|
Adverse Events
CoachingOnlyArm
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
DigitalArm
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
CoachingNRTArm
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
DigitalNRTArm
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CoachingOnlyArm
n=102 participants at risk；n=134 participants at risk
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalArm
n=87 participants at risk；n=126 participants at risk
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
CoachingNRTArm
n=96 participants at risk；n=126 participants at risk
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
|
DigitalNRTArm
n=94 participants at risk；n=122 participants at risk
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Nicotine patch: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Phone Counseling: Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
Digital Coaching: Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.0%
2/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
2.3%
2/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
18.8%
18/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
14.9%
14/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
|
Gastrointestinal disorders
Sore or dry mouth
|
2.0%
2/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
2.3%
2/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
10.4%
10/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
9.6%
9/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
|
Nervous system disorders
Headache
|
3.9%
4/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
4.6%
4/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
12.5%
12/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
14.9%
14/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
|
Nervous system disorders
Dizziness
|
2.9%
3/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
2.3%
2/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
6.2%
6/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
8.5%
8/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
|
Nervous system disorders
Sleeplessness / trouble sleeping
|
0.98%
1/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
2.3%
2/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
6.2%
6/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
9.6%
9/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
|
Psychiatric disorders
Bad or vivid dreams / nightmares
|
0.00%
0/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
2.3%
2/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
6.2%
6/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
7.4%
7/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
|
Gastrointestinal disorders
Nausea / upset stomach
|
2.9%
3/102 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
2.3%
2/87 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
8.3%
8/96 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
19.1%
18/94 • During study participation (3 months)
All-Cause Mortality and Serious Adverse Events were collected in all participants. We did not collect Other (Not Including Serious) Adverse Events on all participants, only those who completed the follow-up survey, which varied by randomized group (n=102 CoachingOnly; n=87 for DigitalArm; n=96 for CoachingNRTArm; n=94 for DigitalNRTArm)"
|
Additional Information
Dr. Elizabeth G. Klein
Ohio State University College of Public Health
Phone: 614-292-5424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place