Trial Outcomes & Findings for Engagement With an Adaptive Mobile Health Smoking Cessation Intervention (NCT NCT04020718)

NCT ID: NCT04020718

Last Updated: 2022-03-10

Results Overview

7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

12 weeks post-randomization

Results posted on

2022-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Early Assessment Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit. Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions. Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.	Late Assessment Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit. Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions. Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.	Early Assessment Non-responders NRT Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Early Assessment Non-responders NRT Plus Coaching Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Late Assessment Non-responders NRT Individuals reporting past 7 day smoking at 8 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Late Assessment Non-responders NRT Plus Coaching Individuals reporting past 7 day smoking at 4 weeks post-enrollment, randomized a second time to 4 weeks of NRT or 4 weeks of NRT plus brief telephone coaching	Early Assessment Responders Individuals reporting past 7 day abstinence from cigarettes at 4 weeks post-enrollment, assigned to continue text messages
Pre-assessment and Adaptation STARTED	16	19	0	0	0	0	0
Pre-assessment and Adaptation COMPLETED	16	15	0	0	0	0	0
Pre-assessment and Adaptation NOT COMPLETED	0	4	0	0	0	0	0
Post-assessment and Adaptation STARTED	0	0	8	6	8	7	2
Post-assessment and Adaptation COMPLETED	0	0	8	5	8	7	2
Post-assessment and Adaptation NOT COMPLETED	0	0	0	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Assessment n=16 Participants Participants are assessed for response to brief telephone advice plus a tailored text message program at 4 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit. Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions. Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.	Late Assessment n=19 Participants Participants are assessed for response to brief telephone advice plus a tailored text message program at 8 weeks post-randomization. Response is based on self-reported 7-day point prevalence abstinence. Those who continue to smoke are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of of mailed NRT plus proactive telephone coaching. Brief telephone advice plus tailored text messages: All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit. Mailed nicotine replacement therapy: Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions. Proactive telephone coaching: Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.	Total n=35 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 12.5 • n=99 Participants	51.3 years STANDARD_DEVIATION 14.2 • n=107 Participants	53.4 years STANDARD_DEVIATION 13.4 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	9 Participants n=107 Participants	16 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	10 Participants n=107 Participants	19 Participants n=206 Participants
Race/Ethnicity, Customized White, Non-Hispanic	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized arican American, Non-Hispanic	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race/Ethnicity, Customized Mixed, Non-Hispanic	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Other, Non-Hispanic	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Time to first cigarette After 60 minutes	1 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants
Time to first cigarette 31-60 minutes	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Time to first cigarette 6-30 minutes	10 Participants n=99 Participants	5 Participants n=107 Participants	15 Participants n=206 Participants
Time to first cigarette Within 5 minutes	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Ready to quit in the next 30 days No, not ready to quit in the next 30 days	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Ready to quit in the next 30 days Yes, ready to quit in the next 30 days	13 Participants n=99 Participants	16 Participants n=107 Participants	29 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks post-randomization

Population: Excluding n=2 withdrawn, n=3 LTFU

7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"

Outcome measures

Outcome measures
Measure	Early Assessment Non-responder NRT n=8 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Non-responder NRT Plus Coaching n=5 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Responder n=2 Participants Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages	Late Assessment Non-responder NRT n=8 Participants Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Non-responder NRT Plus Coaching n=7 Participants Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Responder Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks 0-abstinent	0 Participants	1 Participants	1 Participants	4 Participants	1 Participants	0 Participants
Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks 1-smoking	8 Participants	4 Participants	1 Participants	4 Participants	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks post-randomization

Population: No participants in the late assessment group reported 7 day abstinence (all reported continued smoking) at the 8 week time point.

7-day point prevalence abstinence (0, abstinent; 1, smoking)

Outcome measures

Outcome measures
Measure	Early Assessment Non-responder NRT n=8 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Non-responder NRT Plus Coaching n=5 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Responder n=2 Participants Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages	Late Assessment Non-responder NRT n=8 Participants Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Non-responder NRT Plus Coaching n=7 Participants Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Responder Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks 0-abstinent	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks 1-smoking	8 Participants	5 Participants	2 Participants	8 Participants	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks post-randomization

Population: There were no participants in the late assessment group who reported 7 day abstinence at the 8 week assessment.

Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment

Outcome measures

Outcome measures
Measure	Early Assessment Non-responder NRT n=8 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Non-responder NRT Plus Coaching n=5 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Responder n=2 Participants Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages	Late Assessment Non-responder NRT n=8 Participants Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Non-responder NRT Plus Coaching n=7 Participants Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Responder Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Exhaled Carbon Monoxide Less Than 8 Parts Per Million 1-biochemically verified abstinence	0 Participants	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Exhaled Carbon Monoxide Less Than 8 Parts Per Million 0-no biochemically verified abstinence	8 Participants	4 Participants	1 Participants	5 Participants	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks post-randomization

Population: Analysis compares those randomized to NRT in the second period with those randomized to NRT plus coaching in the second period, pooling early and late assessment arms together for this analysis. Excludes n=2 withdrawn, n=2 quit before second randomization, and n=2 LTFU before second randomization

Number of days when patch and/or lozenge was used

Outcome measures

Outcome measures
Measure	Early Assessment Non-responder NRT n=16 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Non-responder NRT Plus Coaching n=13 Participants Those who continue to smoke at 4 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Early Assessment Responder Those reporting 7 day abstinence at 4 weeks post-enrollment, assigned to continue text messages	Late Assessment Non-responder NRT Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Non-responder NRT Plus Coaching Those who continue to smoke at 8 weeks are randomized to the offer of 4 week supply of mailed nicotine patches and/or lozenges (NRT) or 4 week supply of mailed NRT or 4 weeks of mailed NRT plus brief telephone coaching	Late Assessment Responder Those reporting 7 day abstinence at 8 weeks post-enrollment, assigned to continue text messages.
Self-reported Number of Days Nicotine Lozenge and/or Patch Used	5.8 Days Standard Deviation 2.4	7.0 Days Standard Deviation 0.0	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks post-randomization

Population: No participants randomized to late assessment reported 7 day abstinence at 8 weeks post-enrollment.

Self-reported change in average cigarettes smoked per day