Re-Connect Application for Smoking Cessation

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Abstinent Contingent (AC) Re-Connect

Submission Contingent (SC) Re-Connect

About this trial

This is an interventional other trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rowan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abstinent Contingent (AC) Re-Connect

Submission Contingent (SC) Re-Connect

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Percent negative carbon monoxide samples

We will compare the percentage of CO samples that meet the abstinence goals during the 6-month study.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05224154

First Posted

January 12, 2022

Last Updated

July 12, 2023

Sponsor

Rowan University

Collaborators

University of Kentucky

1. Study Identification

Unique Protocol Identification Number

NCT05224154

Brief Title

Re-Connect Application for Smoking Cessation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rowan University

Collaborators

University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

Participants will be told how they can earn back access to their applications but they will not be told whether this is considered the active or control condition.

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Abstinent Contingent (AC) Re-Connect

Arm Type

Experimental

Arm Description

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).

Arm Title

Submission Contingent (SC) Re-Connect

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Abstinent Contingent (AC) Re-Connect

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Submission Contingent (SC) Re-Connect

Intervention Description

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 Measure Information:

Title

System Usability Survey

Description

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.

Time Frame

through study completion, up to 12-weeks

Title

Reconnect use (RCT, Aim 2)

Description

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.

Time Frame

6-months

Title

Duration of Re-Connect Use (RCT, Aim 2)

Description

Over the 6-month study we will track how long participants are engaged with using Re-Connect.

Time Frame

6-months

Title

Acceptability (RCT, Aim 2)

Description

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.

Time Frame

6-months

Title

Percent negative carbon monoxide samples

Description

We will compare the percentage of CO samples that meet the abstinence goals during the 6-month study.

Time Frame

6-months

Title

7-day point prevalence of self-reported, and CO verified, smoking

Description

Participants will provide self-reports and a CO sample to confirm smoking status throughout the 6-month study.

Time Frame

6-months

Secondary Outcome Measure Information:

Title

Initial Acceptability

Description

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.

Time Frame

1 day

Other Pre-specified Outcome Measures:

Title

Smartphone Use Moderators

Description

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).

Time Frame

6-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bethany Raiff, PhD

Phone

856-256-4500

Ext

53782

Email

raiff@rowan.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bethany Raiff, PhD

Organizational Affiliation

Rowan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rowan University

City

Glassboro

State/Province

New Jersey

ZIP/Postal Code

08028

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bethany Raiff, PhD

Phone

856-256-4500

Ext

5-3782

Email

raiff@rowan.edu

First Name & Middle Initial & Last Name & Degree

Bethany Raiff, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

De-identified data will be shared if there is an appropriate need expressed by the investigator.

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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial