Re-Connect Application for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224154
• Other study ID #: PRO-2020-123
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: Rowan University
• Contact: Bethany Raiff, PhD
• Phone: 856-256-4500
• Email: raiff[@]rowan.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptability of Health Care
• Nicotine Dependence, Cigarettes
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
United States	Rowan University	Glassboro	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rowan University	University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smartphone Use Moderators	Exploratory analyses will be conducted on potential moderator variables (e.g., baseline time spent on phone, number of apps downloaded/used, types of apps used).	6-months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Initial Acceptability	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.	1 day