Trial Outcomes & Findings for Text Messaging for Supporting Quit Attempts (NCT NCT02571244)
NCT ID: NCT02571244
Last Updated: 2018-07-30
Results Overview
No smoking (even a puff) in the past 7 days at the first month follow up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Smoking abstinence at the first month after randomization
Results posted on
2018-07-30
Participant Flow
Participant milestones
| Measure |
Motivational Interview Plus Text Message
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
22
|
|
Overall Study
COMPLETED
|
41
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Motivational Interview Plus Text Message
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Unable to reach out post discharge
|
3
|
0
|
Baseline Characteristics
Text Messaging for Supporting Quit Attempts
Baseline characteristics by cohort
| Measure |
Motivational Interview Plus Text Message
n=44 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations. Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping.
|
Control Arm
n=22 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
48.2 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
47.7 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · White
|
27 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
11 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Smoking abstinence at the first month after randomizationPopulation: The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate was assessed as the first outcome (1-month assessment).
No smoking (even a puff) in the past 7 days at the first month follow up.
Outcome measures
| Measure |
Motivational Interview Plus Text Message
n=44 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.
Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
n=22 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Self Reported Smoking Abstinence
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At the third month after randomizationPopulation: It was included only patients that were able to be contacted for follow up (per protocol analysis).
The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group.
Outcome measures
| Measure |
Motivational Interview Plus Text Message
n=41 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.
Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
n=21 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Daily Cigarettes Consumption at 3 Months Among Continuing Smokers
|
12.9 Number of cigarettes smoked per day
Standard Deviation 5.2
|
14.6 Number of cigarettes smoked per day
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: at the third month after randomizationPopulation: It was included only patients that were able to be contacted for follow up (per protocol analysis).
self reported seek for specialized tobacco treatment after hospitalization
Outcome measures
| Measure |
Motivational Interview Plus Text Message
n=41 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.
Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
n=21 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Self Reported Seek for Specialized Tobacco Treatment
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Smoking abstinence at the third month after randomizationPopulation: The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate, at 3-month assessment, was assessed as a secondary outcome.
No smoking (even a puff) in the past 7 days at the third month after randomization.
Outcome measures
| Measure |
Motivational Interview Plus Text Message
n=44 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.
Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
n=22 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Self Reported Smoking Abstinence
|
14 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At third-month follow upPopulation: Intention to Treat Analysis
Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6.
Outcome measures
| Measure |
Motivational Interview Plus Text Message
n=44 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking, and strategies for a successful quit plan, including information on relapse prevention. Post discharge extended treatment: Participants in this arm will receive a telephone counseling session using a motivational interviewing approach and fifteen or eight days of text messages. The timing, duration, and content of the counseling session will be consistent with guideline-based recommendations.
Motivational Interview plus text message: After discharge the experimental group will receive extended care including a counseling session and text messages. The session will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping
|
Control Arm
n=22 Participants
Inside the hospital: All participants will receive the written materials. Patients with high tobacco dependence (Fagerstrom screening test score 5 or higher) will receive also Nicotine replacement therapy. The written materials provide information on, benefits of quitting smoking and strategies for a successful quit plan, including information on relapse prevention.
Post discharge extended care: None
|
|---|---|---|
|
Carbon Monoxide Verified Smoking Abstinence
|
9 Participants
|
1 Participants
|
Adverse Events
Motivational Interview Plus Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Erica Cruvinel
Federal University of Juiz de Fora/Brazil
Phone: 55-32-99174-8855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place