Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based care setting; and (2) determine the value generated by mPATH in each healthcare setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 74
Healthy Volunteers: t
View:

• Age 45-74 years

• Be identified in the electronic health record as due for routine CRC screening, defined as

‣ No colonoscopy in prior 10 years

⁃ No flexible sigmoidoscopy in prior 5 years

⁃ No CT colography in prior 5 years

⁃ No FIT-DNA test (Cologuard) within prior 3 years

⁃ No Fecal Occult Blood Test within prior 1 year

• Have a cell phone number listed in the EHR

• Have a preferred language of English or Spanish in the EHR

• Upcoming appointment within 9 to 16 days

• Georgia Market Only: Insurance type is listed as Medicare Advantage.

Locations
United States
Georgia
Atrium Health Floyd
RECRUITING
Rome
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Contact Information
Primary
Aliza Randazzo
arandazz@wakehealth.edu
1-336-716-0844
Backup
David Miller, MD, MS
dmiller@wakehealth.edu
1-336-713-5218
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 6500
Treatments
Experimental: mPATH-CRC
Participants randomized to the mPATH arm will receive a text message inviting them to use the mPATH-CRC WebApp. The WebApp verifies individuals are due for routine colorectal cancer (CRC) screening, educates them about their options, and lets them request a screening test via the program.
Placebo_comparator: Usual Care (Control)
Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening.
Related Therapeutic Areas
Sponsors
Collaborators: Wake Forest University Health Sciences, National Cancer Institute (NCI)
Leads: Digital Health Navigation Solutions, Inc

This content was sourced from clinicaltrials.gov