Re-Connect Application for Smoking Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abstinent Contingent (AC) Re-Connect, Submission Contingent (SC) Re-Connect.
- Who it may be relevant to
- Registry conditions: Smoking Cessation, Acceptability of Health Care, Nicotine Dependence, Cigarettes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing
Overview
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.
Interventions
- 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). - 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.
Primary outcome measures
- System Usability Survey [Time frame: through study completion, up to 12-weeks]
- Reconnect use (RCT, Aim 2) [Time frame: 6-months]
- Duration of Re-Connect Use (RCT, Aim 2) [Time frame: 6-months]
- Acceptability (RCT, Aim 2) [Time frame: 6-months]
- Percent negative carbon monoxide samples [Time frame: 6-months]
- 7-day point prevalence of self-reported, and CO verified, smoking [Time frame: 6-months]
Secondary outcome measures (1)
- Initial Acceptability [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Rowan University — Glassboro
Identifiers
NCT: NCT05224154 · PRO-2020-123