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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03978455
Other study ID # 2019-0274
Secondary ID R35CA197573A5342
Status Completed
Phase
First received
Last updated
Start date June 18, 2019
Est. completion date December 19, 2019

Study information

Verified date June 2020
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 19, 2019
Est. primary completion date October 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Learn, Connect, and Quit Mobile Application
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.

Locations

Country Name City State
United States University of Wisconsin Center for Tobacco Research and Intervention Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Cancer Institute (NCI), University of Wisconsin Center for Tobacco Research and Intervention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total time spent watching videos Total minutes spent watching videos presented on the Learn, Connect, and Quit Mobile Application One day
Secondary Clinical Utility of the Learn, Connect, and Quit Mobile Application Clinic staff rating of whether they would like to see use of the LCQ app continue (yes/no) One day
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