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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motívate
Video link
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring Colonoscopy, Early Detection of Cancer, Cancer Screening Tests, Motivational Interviewing, Mobile Health, Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motívate group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Colonoscopy completion
Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2021
Last Updated
June 16, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA), Department of Health and Human Services, University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04987788
Brief Title
e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening Colonoscopy Rates
Official Title
e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening Colonoscopy Rates
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
April 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA), Department of Health and Human Services, University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colonoscopy, Early Detection of Cancer, Cancer Screening Tests, Motivational Interviewing, Mobile Health, Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motívate group
Arm Type
Experimental
Arm Description
Participants will engage with an app on an iPad, smartphone or computer.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participant receive a link to watch a general health information video.
Intervention Type
Behavioral
Intervention Name(s)
Motívate
Intervention Description
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
Intervention Name(s)
Video link
Intervention Description
General health information video link
Primary Outcome Measure Information:
Title
Colonoscopy completion
Description
Screening colonoscopy completion status in medical charts six months after participants are enrolled in the study.
Time Frame
Six months after enrollment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah J. Miller, PsyD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to sarah.miller@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Upon request, we will provide the de-identified dataset to qualified investigators under a Data Use Agreement that provides for: 1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and, (3) a commitment to destroying or returning the data after analyses are completed.

Learn more about this trial

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

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