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Remote Monitoring for Inflammatory Bowel Disease (ASSIST Trial)

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

ASSIST Trial 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.Check my eligibility

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.See study design

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.

ASSIST Trial 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.

ASSIST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medication adherence

Self-reported medication adherence

Secondary outcome measures

Healthcare utilization

IBD Disease Activity

IBD Disease Activity (objective)

+9 more

ASSIST 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER

857 Previous Clinical Trials

672,070 Total Patients Enrolled

2 Trials studying Ulcerative Colitis

232 Patients Enrolled for Ulcerative Colitis

University of CincinnatiOTHER

428 Previous Clinical Trials

634,271 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

216 Patients Enrolled for Ulcerative Colitis

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,533 Total Patients Enrolled

4 Trials studying Ulcerative Colitis

696 Patients Enrolled for Ulcerative Colitis

Media Library

Remote monitoring Clinical Trial Eligibility Overview. Trial Name: NCT05316584 — N/A

Ulcerative Colitis Research Study Groups: Remote Monitoring, Control

Ulcerative Colitis Clinical Trial 2023: Remote monitoring Highlights & Side Effects. Trial Name: NCT05316584 — N/A

Remote monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316584 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol allow individuals over 80 to enroll in this trial?

"According to the qualifications for enrolment into this medical trial, the minimum age is 18 and maximum age is 80."

Answered by AI

What is the purport of this research program?

"For a period of 12 months, the primary output that will be evaluated in this trial is patient-reported medication compliance. Other metrics like Quality of Life (measured by PROMIS Global Health T scores), Patient Reported Outcome Anxiety ratings (also on a scale from 0 to 100) and IBD Disease activity as indexed by Harvey Bradshaw Index for Crohn's patients(0 - no maximum score, higher values indicating increased disease severity)."

Answered by AI

Is recruitment for this research trial currently underway?

"Affirmative. The information available on clinicaltrials.gov states that the research is presently seeking contributors. This experiment was first published online on June 9th 2022 and has recently been amended as of September 28th, looking to recruit 123 patients at a single site."

Answered by AI

How many participants have registered for this clinical evaluation?

"Affirmative. The data hosted on clinicaltrials.gov demonstrates that this research is actively searching for participants, with the initial post dating back to September 6th 2022 and its most recent revision being made on the 28th of September. 123 patients are needed from a single medical centre for this trial."

Answered by AI

What is the criteria for becoming a participant in this trial?

"This clinical trial is enrolling 123 individuals between the ages of 18 and 80 who have been diagnosed with ileocolitis. To be eligible, patients must meet several criteria: possess a minimum age of majority, demonstrate evidence of IBD through medical examinations such as endoscopy or imaging tests, initiate treatment for this disorder soon after enrollment, own a mobile phone that supports data/Wi-Fi access (e.g., iPhone 7 or later; Android release date 2012 or later), comprehend the protocol requirements and grant informed consent in English language."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

Raymond Cross 2022. "A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05316584.

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