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Remote Monitoring for Inflammatory Bowel Disease (ASSIST Trial)

N/A

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age or older

Initiating treatment with a new oral or subcutaneous treatment for IBD

Must not have

Symptomatic peripheral vascular disease

Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will help assess whether or not a remote monitoring digital health system can improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves remote monitoring rather than medication or invasive procedures, there are no direct side effects from the intervention itself. However, participants will continue to experience any side effects associated with their standard IBD treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am starting a new pill or injection treatment for my bowel disease.

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I have been diagnosed with IBD through tests like endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms of poor blood flow in my limbs.

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

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I have unstable chest pain.

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I have a condition that is causing my nervous system to deteriorate.

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I have a history of short bowel syndrome.

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My mental health conditions like depression or schizophrenia are not well-managed.

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I am starting corticosteroids without other oral or injected treatments.

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I have had cancer other than skin cancer in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medication adherence

Self-reported medication adherence

Secondary study objectives

Healthcare utilization

IBD Disease Activity

IBD Disease Activity (objective)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Remote MonitoringExperimental Treatment1 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: ControlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remote monitoring

2021

N/A

~660

0 / 11Eligibility criteria met