Remote Monitoring for Inflammatory Bowel Disease

(ASSIST Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Maryland, Baltimore

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.

Research Team

Eligibility Criteria

Adults with documented Inflammatory Bowel Disease (IBD) starting a new oral or subcutaneous treatment, who own a modern smartphone and can understand English. Excluded are those with certain medical conditions like serious infections, recent surgery plans, some heart diseases, mental health issues not well controlled, or specific bowel surgeries.

Inclusion Criteria

Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access

Ability to understand the protocol and provide informed consent in English

I am 18 years old or older.

Exclusion Criteria

I have symptoms of poor blood flow in my limbs.

Uncontrolled medical or psychiatric disease at the opinion of the investigator

I have a stoma or a surgical connection between my intestine and anus.

Treatment Details

Interventions

• Remote monitoring (Behavioral)

Trial Overview The trial is testing if using a remote monitoring digital system for one year helps patients with IBD stick to their medication schedules better than the usual care does. It also looks at whether this system improves overall health outcomes and reduces the need for healthcare services.

Participant Groups

Group I: Remote Monitoring Experimental Treatment 1 Intervention

At the time of a medication dose, participants scan the smart label by tapping it with their mobile device. Participants receive a notification on their device indicating that their medication adherence was updated. Each day a medication is due, patients receive a morning reminder through SMS message notifying them on their medications schedule. If patients fail to scan the label at a given time (as expected by their specific medication regimen), they will receive an end of day text message. Participants will also complete a patient reported outcome (PRO) 2 assessment at baseline, and then monthly for the entire 12 months of the study through an HTML link sent to patients by SMS message. If nonadherence is present and/or moderate to severe symptoms, an alert will be triggered to the research team. The research team can send the PRO2 survey to patients at any given time, at their discretion, if patients are experiencing a flare or at the time of a change in medication dose.

Group II: Control Active Control 1 Intervention

The standard of care for participants in this study is modeled after the standard of care at all five study sites. Standard of care is based on current evidence-based guidelines including a comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. Personnel used to provide standard of care at each site will vary and may include nurse coordinators, advanced practice providers, social workers, psychologists, dieticians, pharmacists, and other ancillary staff.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Dr. Mohan Suntha

University of Maryland, Baltimore

Chief Executive Officer since 2019

MD from Jefferson Medical College, MBA from Wharton School of Business, BA from Brown University

Dr. Taofeek K. Owonikoko

University of Maryland, Baltimore

Chief Medical Officer

MD, PhD

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Dr. Greg Postel

University of Cincinnati

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Dr. Neville G. Pinto

University of Cincinnati

Chief Executive Officer since 2017

PhD in Chemistry from the University of Virginia

New York University

Collaborator

Trials

249

Recruited

229,000+

Dr. Fritz François

New York University

Chief Medical Officer

MD from NYU Grossman School of Medicine

Dr. Robert I. Grossman

New York University

Chief Executive Officer since 2007

MD from NYU Grossman School of Medicine

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

Synchronyx, LLC

Collaborator

Trials

1

Recruited

120+