My Mobile Advice Program: A Randomized Pilot Feasibility Study

Smoking Cessation Clinical Trial

— MyMAP  

Official title:

Internet-based Medication Adherence Program for Nicotine Dependence Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136498
• Other study ID #: 1R34DA034612
• Status: Completed
• Phase: N/A
• First received: May 9, 2014
• Last updated: October 11, 2017
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to evaluate the acceptability and feasibility of the proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).

Description:

Investigators will develop and pilot test a prototype of the MyMAP intervention.The intervention is designed to help smokers better manage issues known to reduce treatment adherence (withdrawal symptoms, medication side-effects, low motivation, and inadequate behavioral skills for medication adherence) and to facilitate greater communication between patients and providers so clinicians can provide appropriate oversight of medication use, intervene when medically necessary, and address patient concerns that may otherwise lead to non-adherence or early treatment termination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• An invited member of Group Health, a health care system in the Pacific Northwest

• Plan to remain enrolled in Group Health for the next 6 months

• aged 18 - 65

• Eligible for smoking cessation treatment through Group Health insurance coverage

• smoke >= 10 cigs a day

• speak and read in English

• willing to use varenicline and no contraindications for this medication

• ready to quit smoking

• have a smart phone with internet access

• willing to receive study texts and emails

• receive care at a Group Health clinic and have electronic medical records in this system

• fill prescriptions through the Group Health pharmacy

• agree to use birth control while taking study medication, if there is a risk of pregnancy

Exclusion Criteria:

• lifetime history of dementia

• psychosis or bipolar disorder based on self-report or medical record review

• hearing, comprehension or visual limitations that preclude full study participation

• current use of other forms of tobacco

• any medical contraindication for varenicline use

• documented history of suicidal ideation/intent

Related Conditions & MeSH terms

• Medication Adherence
• Smoking Cessation

Intervention

Drug:
• Varenicline
Standard 12 week course of varenicline, provided in both arms

Behavioral:
• Cognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
• MyMAP (My Mobile Advice Program)
Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	University of California, Davis, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

McClure JB, Anderson ML, Bradley K, An LC, Catz SL. Evaluating an Adaptive and Interactive mHealth Smoking Cessation and Medication Adherence Program: A Randomized Pilot Feasibility Study. JMIR Mhealth Uhealth. 2016 Aug 3;4(3):e94. doi: 10.2196/mhealth.60 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point Prevalence Abstinence	Self-report of no-smoking, even a puff during the last 7 days.	5 month follow-up
Secondary	Number of Days of Varenicline Use	Number of days varenicline was used	5 mo follow-up

External Links

•   Primary outcome paper