Smoking Cessation Clinical Trial
Official title:
Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing
Verified date | July 2023 |
Source | Rowan University |
Contact | Bethany Raiff, PhD |
Phone | 856-256-4500 |
raiff[@]rowan.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Rowan University | Glassboro | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rowan University | University of Kentucky |
United States,
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 |
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