Remote Monitoring for Inflammatory Bowel Disease

(ASSIST Trial)

Recruiting at 4 trial locations

Overseen By Millie D Long, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Oral corticosteroids

Disqualifiers: Ileostomy, Colostomy, Imminent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

123 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will be starting a new oral or subcutaneous treatment for inflammatory bowel disease.

What data supports the effectiveness of the treatment Remote monitoring for Inflammatory Bowel Disease?

Research shows that remote monitoring, including telemonitoring and home telemanagement systems, is well accepted by patients with inflammatory bowel disease (IBD). It improves their quality of life and disease management, while being cost-effective in the short term. ^{1 2 3 4 5}

Is remote monitoring safe for people with inflammatory bowel disease?

Remote monitoring for inflammatory bowel disease is generally considered safe and well-accepted by patients. Studies show that it improves quality of life and disease management without significant safety concerns. ^{1 2 3 6 7}

How does remote monitoring differ from other treatments for inflammatory bowel disease?

Remote monitoring for inflammatory bowel disease is unique because it uses mobile health technologies and telemedicine to track disease activity and medication adherence in real-time, improving patient engagement and outcomes. Unlike traditional treatments, it allows for continuous monitoring and personalized interventions without the need for frequent in-person visits. ^{1 2 4 5 8}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Training

Participants complete informed consent, baseline survey, and receive virtual training on the digital health system

1-2 weeks

1 virtual visit

Treatment

Participants use the remote monitoring digital health system to track medication adherence and report outcomes

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Remote monitoring

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+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Synchronyx, LLC

Collaborator

Trials

1

Recruited

120+

Findings from Research

A study involving 10 adult patients with ulcerative colitis showed high acceptance of the home automated telemanagement (UC HAT) system, with 90% of participants willing to use it in the future, indicating its potential for improving patient engagement and adherence to treatment.

Patients found the UC HAT system easy to use and reported that it could enhance monitoring of their symptoms and side effects, suggesting that it may lead to better clinical outcomes and increased patient satisfaction in managing ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home telemanagement for patients with ulcerative colitis (UC HAT). Cross, RK., Cheevers, N., Finkelstein, J.[2021]

The Tappt digital health system is designed to monitor real-time medication adherence in patients with inflammatory bowel diseases (IBDs) using smart label technology, which could help identify and address reasons for nonadherence.

A 12-month randomized controlled trial will assess the effectiveness of this system in improving medication adherence, clinical outcomes, and healthcare use compared to standard care, with an expected enrollment of 123 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial. Axelrad, J., Long, M., Horst, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Are we ready for telemonitoring inflammatory bowel disease? A review of advances, enablers, and barriers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptance of a home telemanagement system in patients with inflammatory bowel disease: a 6-month pilot study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Home telemanagement for patients with ulcerative colitis (UC HAT). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring in IBD: Current State and Future Directions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Development and Validation of an Inflammatory Bowel Diseases Monitoring Index for Use With Mobile Health Technologies. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Telemedicine in inflammatory bowel disease: opportunities and approaches. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of Home Telemonitoring versus Conventional Follow-up: A Randomized Controlled Trial among Teenagers with Inflammatory Bowel Disease. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial. [2023]