- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978455
A Pilot Study of the Learn, Connect, and Quit Mobile Application
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of this study is to develop a novel, effective mobile application for patients to use while waiting in the clinic exam room to see their provider and to access on-line after their visit. The Learn, Connect, and Quit (LCQ) application will present patients with a variety of videos designed to increase their understanding of, and engagement in, evidence-based smoking cessation treatment (e.g., videos that address barriers to cessation and explain treatment options). The LCQ app will also be coordinated within the clinical care system to allow patients to self-refer for smoking treatment and will serve as a prompt to begin a conversation with the provider thereby connecting smokers to evidence-based treatment with minimal staff burden, thus, increasing the feasibility and sustainability of this intervention. This research will pursue the following specific aims:
Specific Aim 1: Develop the Learn, Connect, and Quit mobile application to: 1) present educational and motivational content in an easily accessible manner (i.e., via videos); and 2) provide avenues for smokers to connect to evidence-based treatment (e.g., request a referral to the Wisconsin Tobacco Quitline via the app, initiate a discussion with their provider).
Specific Aim 2: Identify optimal implementation procedures and clinical workflows to facilitate the use of the LCQ app within the clinical setting.
Specific Aim 3: Establish the feasibility, acceptability, and preliminary effects of the Learn, Connect, and Quit app among smokers in a primary care clinic to support an NIH R01 application.
This research will create an innovative, patient-driven intervention that can be integrated into healthcare systems and leverage the patient wait times in traditional clinical settings to provide motivational content and treatment information to increase: motivation, smoking treatment engagement, and connections with evidence-based treatment resources. This innovative product will then be tested in larger implementation trials with external funding.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53711
- University of Wisconsin Center for Tobacco Research and Intervention
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The Smoker Participant Group will consist of adult English-speaking smokers attending a clinic visit at their primary care clinic.
The Clinic Staff Group will consist of adult staff (rooming staff and clinical providers) at the primary care clinic where Smoker Participant Group participants will be recruited.
Description
Inclusion Criteria for Smoker Participant Group:
- participant be age 18 or older, speak and understand English, smoke cigarettes, and complete the referral form agreeing to be contacted for an assessment
Exclusion Criteria:
- none
Inclusion Criteria for Clinic Staff Group:
- must be either rooming staff or clinical provider (e.g., physician, nurse practitioner, etc.)
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients Who Smoke
This group will consist of up to 100 English-speaking adult smokers recruited from their primary care clinic who are willing to complete a brief phone-based interview about their experience in using the "Learn, Connect, and Quit" (LCQ) tablet-based mobile application.
The LCQ app presents smoking and cessation-related educational and motivational content in an easily accessible manner (i.e., via videos) and provides avenues for smokers to connect to evidence-based treatment.
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The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.
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Clinic Staff
Rooming staff and physicians from the primary care clinic (where "Patients Who Smoke" group participants are recruited) will be asked to participate in interviews about the feasibility of implementing the LCQ app including implementation burden, impact on clinical workload, and clinical utility of the app (i.e., Did patients ask more questions about smoking treatment?
How challenging was it to try to give all smokers the app to explore?).
|
The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total time spent watching videos
Time Frame: One day
|
Total minutes spent watching videos presented on the Learn, Connect, and Quit Mobile Application
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Utility of the Learn, Connect, and Quit Mobile Application
Time Frame: One day
|
Clinic staff rating of whether they would like to see use of the LCQ app continue (yes/no)
|
One day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan E Piper, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-0274
- A534253 (Other Identifier: UW Madison)
- SMPH/MEDICINE/GEN INT MD (Other Identifier: UW Madison)
- R35CA197573 (U.S. NIH Grant/Contract)
- Protocol Version 1/22/2019 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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