The trial aims to develop and test an app, called e-Motivate, designed to improve African Americans’ screening colonoscopy rates. The app is a 20-minute app provided to individuals in the clinic after they receive a referral for a screening colonoscopy. Participants enrolled in the trial are randomly assigned to one of two conditions: app condition or control condition. Participants in the control condition receive usual care (e.g., patient navigation). Participants in the app condition complete the app and also receive usual care. Medical chart reviews (6 months post referral) will determine whether or not the participants completed the recommended screening colonoscopy. If proven efficacious, the app can be a useful tool to help increase African Americans’ screening colonoscopy rates and, in doing so, reduce the burden of colorectal cancer in the African American community.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03595904.
PRIMARY OBJECTIVES:
I. To develop and field-test an app, called e-Motivate, designed to improve African Americans’ screening colonoscopy rates.
II. To conduct a randomized controlled trial (RCT) that examines the efficacy of the Motivate app versus a control condition for increasing screening colonoscopy uptake in African Americans.
IIa. To explore the efficacy of the e-Motivate app for improving a secondary adherence outcome.
IIb. To explore mediators and moderators of the e-Motivate app.
III. To examine participants' satisfaction with the e-Motivate app.
OUTLINE:
Phase I: Field testing
Using an iterative approach, the e-Motivate app will be developed, field-tested, and finalized. Drawing from the current literature and our pilot data, we will design the e-Motivate app version 1.0. Then, the app will be field-tested on African Americans referred for a screening colonoscopy (N=20). Qualitative methods (e.g., think aloud exercises) will be implemented to assess the intervention’s feasibility. Quantitative methods will be used to assess the app’s overall usability and acceptability. The results from the first field test will be used to modify the app. Study procedures will be repeated with a new sample (N=20) of African Americans referred for a screening colonoscopy to confirm the feasibility of the I-MIIC 2.0. Based on the results of the second field test, the finalized I-MIIC 3.0 will be created.
PHASE II (RCT): Participants will be African Americans referred for a screening colonoscopy. Participants will be randomly assigned to one of two groups: (1) e-Motivate condition or (2) control condition. Participant in the control condition will receive usual care (i.e., patient navigation). Participants in the e-Motivate condition, in addition to receiving usual care, will complete the app on a tablet in the clinic.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorSarah J. Miller