My Mobile Advice Program: A Randomized Pilot Feasibility Study (MyMAP)

October 11, 2017 updated by: Kaiser Permanente

Internet-based Medication Adherence Program for Nicotine Dependence Treatment

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mHealth self-help + varenicline
Participants in this control arm received standard cognitive-behavioral self-help materials delivered via a mobile health (mHealth) program + a standard course of varenicline.
Drug: Varenicline
Standard 12 week course of varenicline, provided in both arms
Other Names:
  • Chantix
Behavioral: Cognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
Experimental: mHealth MyMAP program + varenicline
Participants in the experimental arm received standard cognitive-behavioral self-help materials delivered via a mHealth program + additional personalized support features (automated, tailored advice managing nicotine withdrawal symptoms and medication side-effects & secure messaging with a cessation counselor; i.e., MyMAP program) + a standard course of varenicline.
Drug: Varenicline
Standard 12 week course of varenicline, provided in both arms
Other Names:
  • Chantix
Behavioral: Cognitive-behavioral self-help
Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence Abstinence
Time Frame: 5 month follow-up
Self-report of no-smoking, even a puff during the last 7 days.
5 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days of Varenicline Use
Time Frame: 5 mo follow-up
Number of days varenicline was used
5 mo follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

University of Michigan
University of California, Davis

Investigators

  • Principal Investigator: Jennifer McClure, PhD, Group Health Research Institute
  • Principal Investigator: Sheryl Catz, PhD, University of California, Davis
  • Principal Investigator: Larry An, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DA034612 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Varenicline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe