Re-Connect Application for Smoking Cessation

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bethany Raiff, PhD; Phone Number: 53782 856-256-4500; Email: raiff@rowan.edu

Study Locations

• United States
  • New Jersey
    • Glassboro, New Jersey, United States, 08028
      • Recruiting
      • Rowan University
      • Contact: Bethany Raiff, PhD; Phone Number: 5-3782 856-256-4500; Email: raiff@rowan.edu
      • Principal Investigator: Bethany Raiff, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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).
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rowan University
• Collaborators: University of Kentucky
• Investigators: Principal Investigator: Bethany Raiff, PhD, Rowan University

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: PRO-2020-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data will be shared if there is an appropriate need expressed by the investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No