← Back to Search

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
Select...
I am 18 years old or older.
Select...
I am starting a new pill or injection treatment for my bowel disease.
Select...
I have been diagnosed with IBD through tests like endoscopy.

ASSIST Trial Timeline

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

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER
866 Previous Clinical Trials
672,552 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
232 Patients Enrolled for Ulcerative Colitis
University of CincinnatiOTHER
430 Previous Clinical Trials
634,368 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
216 Patients Enrolled for Ulcerative Colitis
University of Maryland, BaltimoreLead Sponsor
692 Previous Clinical Trials
376,741 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: Control, Remote Monitoring
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
~6 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top