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Development of a mHealth Intervention for Ambivalent Smokers

Primary Purpose

Tobacco Use Disorder, Smoking Cessation, Motivation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Control mHealth program
Experimental mHealth program
Nicotine patch
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Tobacco Use Disorder focused on measuring mHealth, smoking, smoking cessation, motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years or older;
  • Can speak/read English;
  • Current smoker;
  • Own and regularly use an eligible smartphone;
  • No vision impairments;
  • Willing to install and use the study program;
  • Willing to use birth control if elect to use nicotine replacement during the study (females);
  • Meet definition for ambivalence
  • Not actively using treatment

Exclusion Criteria:

  • Smoke less than 10 cigarettes per day
  • Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
  • Have medical contraindications for nicotine replacement therapy;
  • Another household member is enrolled in the study
  • Unable to verify contact information
  • Fail to install app

Sites / Locations

  • Kaiser Permanente Washington Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Outcomes

Primary Outcome Measures

Program Engagement
Number of unique app user-sessions
Quit Attempt Lasting at Least 24 Hours
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Not Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.

Secondary Outcome Measures

Satisfaction With Assigned App
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Satisfaction With Assigned App
Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Helpfulness of Assigned App
Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Helpfulness of Assigned App
Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Program Engagement - Earned Badges
Number of accumulated badge rewards earned from using the assigned app.
Program Engagement - Earned Badges
Number of accumulated badge rewards earned from using the assigned app.
Self-efficacy to Quit Smoking
Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".
Self-efficacy to Quit Smoking
Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".
Self-efficacy to Stay Quit
Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".
Self-efficacy to Stay Quit
Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".
Earned and Requested Free Nicotine Replacement Therapy
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Earned and Requested Free Nicotine Replacement Therapy
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Quit Attempt Lasting at Least 24 Hours
At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.
Change in Cigarettes/Day
Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.
Change in Cigarettes/Day
Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.
Refrain From Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.

Full Information

First Posted
June 15, 2020
Last Updated
January 3, 2023
Sponsor
Kaiser Permanente
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04560868
Brief Title
Development of a mHealth Intervention for Ambivalent Smokers
Official Title
Development of a mHealth Intervention for Ambivalent Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Smoking Cessation, Motivation, Behavior, Smoking
Keywords
mHealth, smoking, smoking cessation, motivation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Control mHealth program
Intervention Description
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Intervention Type
Device
Intervention Name(s)
Experimental mHealth program
Intervention Description
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
Primary Outcome Measure Information:
Title
Program Engagement
Description
Number of unique app user-sessions
Time Frame
Assessed at 3-month follow-up
Title
Quit Attempt Lasting at Least 24 Hours
Description
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Time Frame
Assessed at 3-month follow-up
Title
Not Smoking (Even a Puff) in the Last 7 Days
Description
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Time Frame
Assessed at 3-month follow-up
Secondary Outcome Measure Information:
Title
Satisfaction With Assigned App
Description
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Time Frame
Assessed at 1 month
Title
Satisfaction With Assigned App
Description
Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Time Frame
Assessed at 3 months
Title
Helpfulness of Assigned App
Description
Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Time Frame
Assessed at 1 month.
Title
Helpfulness of Assigned App
Description
Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Time Frame
Assessed at 3 months
Title
Program Engagement - Earned Badges
Description
Number of accumulated badge rewards earned from using the assigned app.
Time Frame
Assessed at 1-month follow-up
Title
Program Engagement - Earned Badges
Description
Number of accumulated badge rewards earned from using the assigned app.
Time Frame
Assessed at 3-month follow-up
Title
Self-efficacy to Quit Smoking
Description
Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".
Time Frame
Assessed at 1 month
Title
Self-efficacy to Quit Smoking
Description
Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".
Time Frame
Assessed at 3 months
Title
Self-efficacy to Stay Quit
Description
Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".
Time Frame
Assessed at 1 month
Title
Self-efficacy to Stay Quit
Description
Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".
Time Frame
Assessed at 3 months
Title
Earned and Requested Free Nicotine Replacement Therapy
Description
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Time Frame
Assessed at 1-month follow-up
Title
Earned and Requested Free Nicotine Replacement Therapy
Description
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Time Frame
Assessed at 3-month follow-up
Title
Quit Attempt Lasting at Least 24 Hours
Description
At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.
Time Frame
Assessed at 1 month follow-up
Title
Change in Cigarettes/Day
Description
Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.
Time Frame
Assessed at baseline and 1 month
Title
Change in Cigarettes/Day
Description
Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.
Time Frame
Assessed at baseline and 3 months
Title
Refrain From Smoking (Even a Puff) in the Last 7 Days
Description
7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.
Time Frame
Assessed at 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older; Can speak/read English; Current smoker; Own and regularly use an eligible smartphone; No vision impairments; Willing to install and use the study program; Willing to use birth control if elect to use nicotine replacement during the study (females); Meet definition for ambivalence Not actively using treatment Exclusion Criteria: Smoke less than 10 cigarettes per day Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia; Have medical contraindications for nicotine replacement therapy; Another household member is enrolled in the study Unable to verify contact information Fail to install app
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer McClure, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared.

Learn more about this trial

Development of a mHealth Intervention for Ambivalent Smokers

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