Internet-Based Motivational Interviewing for Colonoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 7/25/2018 |
| Start Date: | November 20, 2017 |
| End Date: | July 1, 2020 |
| Contact: | Sarah Miller, PsyD |
| Email: | sarah.miller@mssm.edu |
| Phone: | 1-212-824-7783 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10029
Principal Investigator: Sarah Miller, PsyD
Phone: 212-824-7783
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