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Internet-Based Motivational Interviewing for Colonoscopy

Internet-Based Motivational Interviewing for Colonoscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03595904
Enrollment
78
Registered
2018-07-23
Start date
2017-11-20
Completion date
2020-05-08
Last updated
2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

colorectal neoplasms, colonoscopy, African Americans, Telemedicine

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.

Interventions

BEHAVIORALE-Motivate group

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).

BEHAVIORALUsual Care Group

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded to the participants' assigned study group.

Intervention model description

Participants are randomly assigned to one of two groups (1:1).

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Completed a Screening Colonoscopysix months after the initial referralSix months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy

Secondary

MeasureTime frameDescription
Number of Participants With Adequate Bowel Prep Qualitysix months after initial referralAn 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 Appointmentssix monthsProcess variable was assessed via medical chart review six months following the initial referral
Number of Patients Who Had Rescheduled Appointmentssix monthsProcess variable was assessed via medical chart review six months following the initial referral
Number of Participants Who Were No-show Appointmentssix monthsProcess variable was assessed via medical chart review six months following the initial referral

Countries

United States

Participant flow

Recruitment details

Recruitment sites: Primary care and Gastroenterology clinics in the Mount Sinai Health System. Enrollment started in November 2017 through November 2019.

Participants by arm

ArmCount
E-Motivate Group
Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
29
Usual Care Group
Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions).
34
Total63

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyCOVID-19 halt in non-essential appointments during 6 month follow up21
Overall StudyDeemed medically ineligible for direct access colonoscopy43
Overall StudyInsurance complications10
Overall StudyProtocol Violation31

Baseline characteristics

CharacteristicUsual Care GroupTotalE-Motivate Group
Age, Continuous59.15 years
STANDARD_DEVIATION 7.02
58.87 years
STANDARD_DEVIATION 7.16
58.55 years
STANDARD_DEVIATION 7.42
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants60 Participants28 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
32 Participants58 Participants26 Participants
Race (NIH/OMB)
More than one race
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
26 Participants44 Participants18 Participants
Sex: Female, Male
Male
8 Participants19 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 34
other
Total, other adverse events
0 / 290 / 34
serious
Total, serious adverse events
0 / 290 / 34

Outcome results

Primary

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

Time frame: six months after the initial referral

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-Motivate GroupNumber of Participants Who Completed a Screening Colonoscopy19 Participants
Usual Care GroupNumber of Participants Who Completed a Screening Colonoscopy19 Participants
Secondary

Number of Participants Who Had Canceled Appointments

Process variable was assessed via medical chart review six months following the initial referral

Time frame: six months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-Motivate GroupNumber of Participants Who Had Canceled Appointments5 Participants
Usual Care GroupNumber of Participants Who Had Canceled Appointments11 Participants
Secondary

Number of Participants Who Were No-show Appointments

Process variable was assessed via medical chart review six months following the initial referral

Time frame: six months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-Motivate GroupNumber of Participants Who Were No-show Appointments0 Participants
Usual Care GroupNumber of Participants Who Were No-show Appointments2 Participants
Secondary

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.

Time frame: six months after initial referral

Population: Data only available for those participants with bowel prep quality ratings.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-Motivate GroupNumber of Participants With Adequate Bowel Prep Quality12 Participants
Usual Care GroupNumber of Participants With Adequate Bowel Prep Quality13 Participants
Secondary

Number of Patients Who Had Rescheduled Appointments

Process variable was assessed via medical chart review six months following the initial referral

Time frame: six months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
E-Motivate GroupNumber of Patients Who Had Rescheduled Appointments0 Participants
Usual Care GroupNumber of Patients Who Had Rescheduled Appointments6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026