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Internet-Based Motivational Interviewing for Colonoscopy

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-Motivate group
Usual Care Group
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring colorectal neoplasms, colonoscopy, African Americans, Telemedicine

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • self-identified as African American/Black
  • received a referral for a screening colonoscopy
  • recommended age to begin screening for colorectal cancer (based on current guidelines)
  • English speaking

Exclusion Criteria:

  • hearing or vision impaired
  • participated in the previous iterative field testing

Sites / Locations

  • Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E-Motivate group

Usual Care Group

Arm Description

Participants complete a 20-minute tablet app, called e-Motivate, and receive usual care.

Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy

Outcomes

Primary Outcome Measures

Number of Participants Who Completed a Screening Colonoscopy
Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy

Secondary Outcome Measures

Number of Participants With Adequate Bowel Prep Quality
An adequate prep which is defined as "adequate, excellent or good". An inadequate prep would be defined as "inadequate, poor or fair". Six months following the initial referral, medical charts was reviewed to determine the physician-rated bowel prep quality for participants who completed the screening colonoscopy.
Number of Participants Who Had Canceled Appointments
Process variable was assessed via medical chart review six months following the initial referral
Number of Patients Who Had Rescheduled Appointments
Process variable was assessed via medical chart review six months following the initial referral
Number of Participants Who Were No-show Appointments
Process variable was assessed via medical chart review six months following the initial referral

Full Information

First Posted
July 11, 2018
Last Updated
June 16, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03595904
Brief Title
Internet-Based Motivational Interviewing for Colonoscopy
Official Title
Internet-Based Motivational Interviewing for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
May 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. Previous research suggests that a motivational interviewing based intervention may help improve screening colonoscopy uptake. This study will conduct a randomized clinical trial examining the efficacy of a motivational interviewing informed tablet app, called e-Motivate, to improve African Americans' screening colonoscopy uptake. Participants will be African Americans who receive a referral for a screening colonoscopy. Participants (N=200) will be randomly assigned to one of two groups: (1) usual care group (N=100); or (2) e-Motivate app group (N=100). Participants in the usual care group will receive standard clinical care which includes patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will complete the e-Motivate app in the clinic immediately after they receive a referral for the screening colonoscopy. The participants in the e-Motivate app group will also receive usual care. Six months following the initial referral, participants' medical charts will be reviewed to determine whether the participants completed the recommended screening colonoscopy. Secondary outcomes (e.g., bowel prep quality, number of cancellations) will also be analyzed.
Detailed Description
Colorectal cancer (CRC), a largely preventable disease, remains the third leading cause of cancer death in the United States. Compared to other racial groups, African Americans have the highest CRC morbidity and mortality rates. Recent reports have found that African Americans' CRC incidence rates are 20% higher and mortality rates are 45% higher than those of whites. Given these disparities, it is critical to increase African Americans' participation in CRC screenings. Of the recommended CRC screening mechanisms, a colonoscopy is often the preferred method because it allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than 1/3 of African Americans have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. A motivational interviewing (MI) intervention can help improve African Americans' screening colonoscopy uptake. MI is a brief patient-centered intervention that increases perceived competence, autonomy, and relatedness in order to promote behavioral change. Extensive research supports the efficacy of MI to promote preventive health screening uptake, including increasing screening colonoscopy rates, and MI has proven efficacious with African Americans across a wide range of diseases. Traditionally, MI is delivered live, where individuals meet with a professional for a one-on-one intervention. Although efficacious, live-MI is not without limitations. Of greatest concern, live-MI requires both staffing and economic resources, limiting its ability to be widely disseminated. A digital intervention, such a tablet app, may overcome these limitations. By eliminating the need for an on-site professional, a tablet app is a high reach, low cost intervention with the potential to have a significant public health impact. The primary goal of this study is to conduct a randomized clinical trial (RCT) that examines the efficacy of a tablet app, called e-Motivate, to improve screening colonoscopy rates in African Americans. The app first underwent iterative field-testing and subsequent modifications to ensure that the app had high usability and acceptability ratings. The final version of the app, called e-Motivate, will be tested in a randomized clinical trial. African American patients referred for a screening colonoscopy will be recruited to the RCT. Participants (N=200) will be randomly assigned to a usual care group (N=100) or an e-Motivate group (N=100). Participants in the usual care group will receive standard patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will receive standard clinical care and will also complete the e-Motivate app. The app will be a 20-minute tablet app that will include motivational interviewing informed exercises and education. The app will be completed in the clinic immediately after a participant receives a referral for a screening colonoscopy. Six months following the initial referral, participants medical charts will be reviewed to determine whether they completed the recommended screening colonoscopy. It is hypothesized that participants in the e-Motivate group will be more likely to complete the recommended screening colonoscopy. The study will also explore whether the e-Motivate app can improve secondary outcomes (e.g., bowel prep quality, number of cancellations). Potential mediators, informed by Self Determination Theory, will be evaluated. Potential moderators (e.g., age, education, family history of CRC) will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
colorectal neoplasms, colonoscopy, African Americans, Telemedicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of two groups (1:1).
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to the participants' assigned study group.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-Motivate group
Arm Type
Experimental
Arm Description
Participants complete a 20-minute tablet app, called e-Motivate, and receive usual care.
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy
Intervention Type
Behavioral
Intervention Name(s)
E-Motivate group
Intervention Description
Participants in the e-Motivate group will receive standard clinical care which includes patient navigation (e.g., scheduling and reminders). They will also complete a 20-minute, motivational interviewing informed tablet app in the clinic immediately after they receive a referral for a screening colonoscopy. The tablet app consists of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Group
Intervention Description
Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy. In particular, they will receive patient navigation which includes scheduling the colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions.
Primary Outcome Measure Information:
Title
Number of Participants Who Completed a Screening Colonoscopy
Description
Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy
Time Frame
six months after the initial referral
Secondary Outcome Measure Information:
Title
Number of Participants With Adequate Bowel Prep Quality
Description
An adequate prep which is defined as "adequate, excellent or good". An inadequate prep would be defined as "inadequate, poor or fair". Six months following the initial referral, medical charts was reviewed to determine the physician-rated bowel prep quality for participants who completed the screening colonoscopy.
Time Frame
six months after initial referral
Title
Number of Participants Who Had Canceled Appointments
Description
Process variable was assessed via medical chart review six months following the initial referral
Time Frame
six months
Title
Number of Patients Who Had Rescheduled Appointments
Description
Process variable was assessed via medical chart review six months following the initial referral
Time Frame
six months
Title
Number of Participants Who Were No-show Appointments
Description
Process variable was assessed via medical chart review six months following the initial referral
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: self-identified as African American/Black received a referral for a screening colonoscopy recommended age to begin screening for colorectal cancer (based on current guidelines) English speaking Exclusion Criteria: hearing or vision impaired participated in the previous iterative field testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Miller, PsyD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27599713
Citation
Miller SJ, Foran-Tuller K, Ledergerber J, Jandorf L. Motivational interviewing to improve health screening uptake: A systematic review. Patient Educ Couns. 2017 Feb;100(2):190-198. doi: 10.1016/j.pec.2016.08.027. Epub 2016 Aug 26.
Results Reference
background

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Internet-Based Motivational Interviewing for Colonoscopy

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