Re-Connect Application for Smoking Cessation

NCT05224154 | Recruiting

• 1 other identifier: PRO-2020-123
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This series of studies will explore the acceptability, feasibility, and preliminary efficacy of making access to smartphone applications contingent on objective evidence of smoking abstinence.

Conditions

Smoking Cessation; Acceptability of Health Care; Nicotine Dependence, Cigarettes

Outcome Measures

Primary Outcomes (6)

• System Usability Survey

  A survey that participants in Aim 1 usability testing will complete after testing out the Re-Connect application. Focus and feedback group participants, as well as single-case design participants, will complete this survey and a score of 75 or higher will be required before moving to the RCT in Aim 2.

  through study completion, up to 12-weeks

• Reconnect use (RCT, Aim 2)

  Over the 6-month observation period we will track the how much and to what extent participants use Re-Connect and continue to submit CO samples.

  6-months

• Duration of Re-Connect Use (RCT, Aim 2)

  Over the 6-month study we will track how long participants are engaged with using Re-Connect.

  6-months

• Acceptability (RCT, Aim 2)

  At three time points we will have the participants complete a Treatment Acceptability Questionnaire to provide quantitative and qualitative feedback on their experience with using Re-Connect.

  6-months

• Percent negative carbon monoxide samples

  We will compare the percentage of CO samples that meet the abstinence goals during the 6-month study.

  6-months

• 7-day point prevalence of self-reported, and CO verified, smoking

  Participants will provide self-reports and a CO sample to confirm smoking status throughout the 6-month study.

  6-months

Secondary Outcomes (1)

• Initial Acceptability

  1 day

Other Outcomes (1)

• Smartphone Use Moderators

  6-months

Study Arms (2)

Abstinent Contingent (AC) Re-Connect

EXPERIMENTAL

Participants in this group will be able to unblock highly desired, but non-essential (e.g., social networking, shopping, games) applications contingent on meeting goals for smoking abstinence, as verified by meeting carbon monoxide goals (CO\<=6ppm).

Behavioral: Abstinent Contingent (AC) Re-Connect

Submission Contingent (SC) Re-Connect

ACTIVE COMPARATOR

Participants in this group will also be able to unblock their applications, but contingent on submitting CO samples and independent of meeting CO goals for smoking abstinence.

Behavioral: Submission Contingent (SC) Re-Connect

Interventions

Abstinent Contingent (AC) Re-Connect BEHAVIORAL

Participants in this group will be able to unblock highly desired, but non-essential (e.g., social networking, shopping, games) applications contingent on meeting goals for smoking abstinence, as verified by meeting carbon monoxide goals (CO\<=6ppm).

Abstinent Contingent (AC) Re-Connect

Submission Contingent (SC) Re-Connect BEHAVIORAL

Participants in this group will also be able to unblock their applications, but contingent on submitting CO samples and independent of meeting CO goals for smoking abstinence.

Submission Contingent (SC) Re-Connect

Eligibility Criteria

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

You may qualify if:

• individuals who report smoking at least 10 cigarettes per day for at least 2 years, -18 years of age or older
• do not have any health complications that might interfere with the study or require more intensive treatment (e.g., emphysema, chronic obstructive pulmonary disorder, asthma, lactose intolerance)
• report a strong desire to quit smoking (8 or higher on a 10-point Likert scale)
• has prior experience using a smartphone, speak English, and are literate, will be eligible for the study.

You may not qualify if:

• Individuals with mental health complications that are either un-managed or that have been managed for less than 6-months

Sponsors & Collaborators

• Rowan University: lead
• University of Kentucky: collaborator

Study Sites (1)

Rowan University

Glassboro, New Jersey, 08028, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Patient Acceptance of Health Care; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Treatment Adherence and Compliance; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Bethany Raiff, PhD

  Rowan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Raiff, PhD

CONTACT

856-256-4500; raiff@rowan.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be told how they can earn back access to their applications but they will not be told whether this is considered the active or control condition.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 1 will use small focus groups and feedback sessions (n = 4-6) to gain insight into the acceptability and usability of Re-Connect. Up to 3 single-case design studies (n = 4/round) will then be conducted to get more extended use of the app in a real world context to get additional information about usability and acceptability of the app. Aim 2 will involve a 2-group (AC vs SC), pilot randomized control trial to test the feasibility, acceptability, and preliminary efficacy of Re-Connect.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 4, 2022
• Study Start: December 14, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

US (1)