Development of a mHealth Intervention for Ambivalent Smokers

NCT04560868 | Completed Phase 1 Results

• 2 other identifiers: 1401452R21CA234003
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Smoking Cessation; Motivation; Behavior, Smoking

Keywords

mHealth; smoking; smoking cessation; motivation

Outcome Measures

Primary Outcomes (3)

• Program Engagement

  Number of unique app user-sessions

  Assessed at 3-month follow-up

• 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.

  Assessed at 3-month follow-up

• 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.

  Assessed at 3-month follow-up

Secondary Outcomes (16)

• Satisfaction With Assigned App

  Assessed at 1 month

• Satisfaction With Assigned App

  Assessed at 3 months

• Helpfulness of Assigned App

  Assessed at 1 month.

• Helpfulness of Assigned App

  Assessed at 3 months

• Program Engagement - Earned Badges

  Assessed at 1-month follow-up

Study Arms (2)

Control

ACTIVE COMPARATOR

Device: Control mHealth program; Drug: Nicotine patch

Experimental

EXPERIMENTAL

Device: Experimental mHealth program; Drug: Nicotine patch

Interventions

Control mHealth program DEVICE

The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.

Control

Experimental mHealth program DEVICE

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.

Experimental

Nicotine patch DRUG

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.

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• McClure JB, Heffner JL, Krakauer C, Mun S, Klasnja P, Catz SL. Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study. JMIR Mhealth Uhealth. 2023 Jun 28;11:e46155. doi: 10.2196/46155.

  PMID: 37379059 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 57). This pilot study was not powered to provide definitive answers about the efficacy of the intervention in promoting smoking abstinence. A larger trial is needed for this.

Results Point of Contact

• Title: Director, Investigative Science
• Organization: Kaiser Permanente Washington Health Research Institute

jennifer.b.mcclure@kp.org

206-287-2737

Study Officials

• Jennifer McClure, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: September 23, 2020
• Study Start: December 16, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: January 23, 2023
• Results First Posted: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)