Re-Connect Application for Smoking Cessation

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Abstinent Contingent (AC) Re-Connect
* Behavioral: Submission Contingent (SC) Re-Connect


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abstinent Contingent (AC) Re-Connect<br>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<br>* 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).<br>|
| Active Comparator: Submission Contingent (SC) Re-Connect<br>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<br>* 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.<br>|

What is the study measuring?
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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 |