A Pilot Study of the Learn, Connect, and Quit Mobile Application

June 9, 2020 updated by: University of Wisconsin, Madison
This research study aims to develop and test the effectiveness of a mobile application for patients who smoke to use while waiting in the clinic exam room to see their provider. The application will present patients with a variety of videos designed to increase their engagement in evidence-based smoking cessation treatment and offer them action steps to engage in smoking-related treatment or discussions with their provider.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Actual)

October 2, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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