Re-Connect Application for Smoking Cessation

Not Applicable

Recruiting

• Conditions: Acceptability of Health Care; Nicotine Dependence, Cigarettes; Smoking Cessation
• Interventions: Behavioral: Abstinent Contingent (AC) Re-Connect; Behavioral: Submission Contingent (SC) Re-Connect

• Registration Number: NCT05224154
• Lead Sponsor: Rowan University

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.

Detailed Description

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 Timeline

• Study Start: 2021-12-14
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abstinent Contingent (AC) Re-Connect	Abstinent Contingent (AC) Re-Connect	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).
Submission Contingent (SC) Re-Connect	Submission Contingent (SC) Re-Connect	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.

Primary Outcome Measures

Name	Time	Method
Reconnect use (RCT, Aim 2)	6-months	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.
Duration of Re-Connect Use (RCT, Aim 2)	6-months	Over the 6-month study we will track how long participants are engaged with using Re-Connect.
Percent negative carbon monoxide samples	6-months	We will compare the percentage of CO samples that meet the abstinence goals during the 6-month study.
Acceptability (RCT, Aim 2)	6-months	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.
System Usability Survey	through study completion, up to 12-weeks	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.
7-day point prevalence of self-reported, and CO verified, smoking	6-months	Participants will provide self-reports and a CO sample to confirm smoking status throughout the 6-month study.

Secondary Outcome Measures

Name	Time	Method
Initial Acceptability	1 day	Individuals who respond to our advertisement for a smoking cessation intervention will be given information about Re-Connect and then they will be given the option of continuing to participate or discontinuing. Participants who discontinue will be asked why they are not interested to inform future versions of the intervention to make it more widely acceptable and therefore more likely to be adopted by a broader population.

Trial Locations

Locations (1)

Rowan University; 🇺🇸 Glassboro, New Jersey, United States