Clinical trial NCT05224154: Re-Connect Application for Smoking Cessation
Official title: Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Acceptability of Health Care
Nicotine Dependence, Cigarettes
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2022-02-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

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

Primary outcomes:
measure: System Usability Survey
timeFrame: through study completion, up to 12-weeks
measure: Reconnect use (RCT, Aim 2)
timeFrame: 6-months
measure: Duration of Re-Connect Use (RCT, Aim 2)
timeFrame: 6-months
measure: Acceptability (RCT, Aim 2)
timeFrame: 6-months
measure: Percent negative carbon monoxide samples
timeFrame: 6-months
measure: 7-day point prevalence of self-reported, and CO verified, smoking
timeFrame: 6-months
Secondary outcomes:
measure: Initial Acceptability
timeFrame: 1 day
Other outcomes:
measure: Smartphone Use Moderators
timeFrame: 6-months
Locations:
city: Glassboro
country: United States
facility: Rowan University
state: New Jersey
Study officials:
affiliation: Rowan University
name: Bethany Raiff, PhD
role: PRINCIPAL_INVESTIGATOR
References: