e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening Colonoscopy Rates

NCT ID: NCT04987788

Last Updated: 2024-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2023-04-27

Brief Summary

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Among Latinos, a fast growing and underserved population, Colorectal Cancer (CRC) is the third leading cause of cancer death in men and in women. Compared to non-Latino whites, Latinos are less likely to be diagnosed with localized CRC and more likely to be diagnosed with advanced stage disease. Of the recommended CRC screening tests, a colonoscopy allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than half of Latinos have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years).

The purpose of this study is to develop and begin to test an electronically-delivered motivational interviewing progressive web application (e-MI app), called Motívate. The Motívate app will be offered in both English and Spanish to patients who self-identify as Latino/a/x, after they receive a referral for a screening colonoscopy.

Detailed Description

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A pilot study will be conducted to begin to examine the efficacy of the Motívate app for improving screening colonoscopy uptake among Latinos. Participants (N=80) will be randomly assigned, stratified for language, to one of two groups: Motívate app (N=40) or general health information video (N=40). The results of the pilot study will inform power calculations for a future randomized clinical trial that will formally test the efficacy of the app. If this program of research proves the Motívate app efficacious there is a strong argument to integrate the app into standard clinical care in order to reduce the overall burden of CRC in the growing and vulnerable Latino community.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Motívate group

Participants will engage with an app on an iPad, smartphone or computer.

Group Type EXPERIMENTAL

Motívate

Intervention Type BEHAVIORAL

The Motívate app can be used in English or Spanish and involves four sequential phases. 1) The engaging phase uses videos to welcome participants. 2) Patients willing to discuss the decision to have a screening colonoscopy will answer multiple-choice questions on colorectal cancer prevention - completing the focusing phase. Optional videos will offer additional information. 3) The evoking phase consists of interactive Motivational Interviewing exercises to help participants elicit motivations to get a screening colonoscopy. 4) During the planning phase, participants will view a video that will discuss the steps needed to prepare for the colonoscopy.

Control Group

Participant receive a link to watch a general health information video.

Group Type ACTIVE_COMPARATOR

Video link

Intervention Type BEHAVIORAL

General health information video link

Interventions

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Motívate

The Motívate app can be used in English or Spanish and involves four sequential phases. 1) The engaging phase uses videos to welcome participants. 2) Patients willing to discuss the decision to have a screening colonoscopy will answer multiple-choice questions on colorectal cancer prevention - completing the focusing phase. Optional videos will offer additional information. 3) The evoking phase consists of interactive Motivational Interviewing exercises to help participants elicit motivations to get a screening colonoscopy. 4) During the planning phase, participants will view a video that will discuss the steps needed to prepare for the colonoscopy.

Intervention Type BEHAVIORAL

Video link

General health information video link

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-identified as Latino/a/x;
* English or Spanish-speaking;
* Received a physician referral for a screening colonoscopy;
* Has access to a tablet, smartphone, or computer with working Internet.

Exclusion Criteria

* Hearing or vision impaired;
* Aim 1 or 2 participant.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Department of Health and Human Services

FED

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Sarah Miller

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah J. Miller, PsyD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R34AG059705

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-18-00328-MOD003

Identifier Type: -

Identifier Source: org_study_id

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