Trial Outcomes & Findings for My Mobile Advice Program: A Randomized Pilot Feasibility Study (NCT NCT02136498)

NCT ID: NCT02136498

Last Updated: 2017-11-13

Results Overview

Self-report of no-smoking, even a puff during the last 7 days.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

5 month follow-up

Results posted on

2017-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	mHealth Self-help + Varenicline Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc.	mHealth MyMAP + Varenicline Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor.
Overall Study STARTED	33	33
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

My Mobile Advice Program: A Randomized Pilot Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mHealth Self-help + Varenicline n=33 Participants Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc.	mHealth MyMAP + Varenicline n=33 Participants Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor.	Total n=66 Participants Total of all reporting groups
Age, Continuous	50.6 years STANDARD_DEVIATION 8.9 • n=5 Participants	48.4 years STANDARD_DEVIATION 8.4 • n=7 Participants	49.5 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized White	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants
Race/Ethnicity, Customized Non-white	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Cigarettes smoked per day	16.9 cigarettes STANDARD_DEVIATION 4.5 • n=5 Participants	18.5 cigarettes STANDARD_DEVIATION 9.1 • n=7 Participants	17.7 cigarettes STANDARD_DEVIATION 7.2 • n=5 Participants
Prior use of varenicline Used varenicline previously	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Prior use of varenicline Never used varenicline	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 month follow-up

Population: Intent to treat analyses with missing cases imputed as smokers.

Self-report of no-smoking, even a puff during the last 7 days.

Outcome measures

Outcome measures
Measure	mHealth Self-help + Varenicline n=33 Participants Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc.	Augmented mHealth Self-help + Varenicline n=33 Participants Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor.
Point Prevalence Abstinence	24 Percentage of people not smoking	36 Percentage of people not smoking

SECONDARY outcome

Timeframe: 5 mo follow-up

Number of days varenicline was used

Outcome measures

Outcome measures
Measure	mHealth Self-help + Varenicline n=33 Participants Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc.	Augmented mHealth Self-help + Varenicline n=33 Participants Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor.
Number of Days of Varenicline Use	39 Mean number of days Standard Deviation 28.9	46 Mean number of days Standard Deviation 31.9

Adverse Events

mHealth Self-help + Varenicline

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

mHealth MyMAP + Varenicline

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	mHealth Self-help + Varenicline n=33 participants at risk Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc.	mHealth MyMAP + Varenicline n=33 participants at risk Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor.
Psychiatric disorders Passive suicidal ideation without intent	0.00% 0/33 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	3.0% 1/33 • Number of events 1 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.

Other adverse events

Additional Information

Principle Investigator

Group Health Research Institute

Phone: 206-287-2737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	mHealth Self-help + Varenicline n=33 participants at risk Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline. Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc.	mHealth MyMAP + Varenicline n=33 participants at risk Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline. The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor.
Psychiatric disorders Anger or irritability	33.3% 11/33 • Number of events 12 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	45.5% 15/33 • Number of events 24 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Psychiatric disorders Anxiety	24.2% 8/33 • Number of events 9 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	24.2% 8/33 • Number of events 12 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Gastrointestinal disorders Change in appetite	45.5% 15/33 • Number of events 23 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	27.3% 9/33 • Number of events 16 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Psychiatric disorders Confusion/difficulty concentrating	18.2% 6/33 • Number of events 7 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	24.2% 8/33 • Number of events 12 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Gastrointestinal disorders Constipation	15.2% 5/33 • Number of events 6 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	15.2% 5/33 • Number of events 9 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Respiratory, thoracic and mediastinal disorders Cough	45.5% 15/33 • Number of events 19 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	39.4% 13/33 • Number of events 16 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Psychiatric disorders Craving to smoke	66.7% 22/33 • Number of events 40 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	90.9% 30/33 • Number of events 74 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Psychiatric disorders Depression	6.1% 2/33 • Number of events 2 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	12.1% 4/33 • Number of events 7 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Gastrointestinal disorders Diarhhea	15.2% 5/33 • Number of events 6 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	9.1% 3/33 • Number of events 4 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
General disorders vivid or unusual dreams	63.6% 21/33 • Number of events 24 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	57.6% 19/33 • Number of events 36 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
General disorders Drowsiness	12.1% 4/33 • Number of events 4 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	6.1% 2/33 • Number of events 2 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Gastrointestinal disorders Gas	39.4% 13/33 • Number of events 14 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	45.5% 15/33 • Number of events 33 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
General disorders Headache	33.3% 11/33 • Number of events 12 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	36.4% 12/33 • Number of events 23 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
General disorders Insomnia or trouble sleeping	36.4% 12/33 • Number of events 13 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	54.5% 18/33 • Number of events 33 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Gastrointestinal disorders Nausea	30.3% 10/33 • Number of events 11 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	33.3% 11/33 • Number of events 15 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
General disorders Rapid heart beat or chest pain	0.00% 0/33 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	6.1% 2/33 • Number of events 3 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Gastrointestinal disorders stomach pain or vomiting	27.3% 9/33 • Number of events 10 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	21.2% 7/33 • Number of events 8 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Psychiatric disorders Memory problems	3.0% 1/33 • Number of events 1 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	0.00% 0/33 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.
Skin and subcutaneous tissue disorders Rash	3.0% 1/33 • Number of events 1 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.	9.1% 3/33 • Number of events 3 • Adverse events were monitored throughout the study period (~ 6 months). Medication side-effects/nicotine withdrawal symptoms (adverse events) were assessed at each follow-up using a standard checklist of events, resulting in a high number of reports in both arms. Experimental participants were also asked to report ongoing side-effects and symptoms to receive tailored treatment advice, increasing reports in this arm.