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Behavioural Intervention

Digital Health Tools for Liver Cirrhosis (HEROIC Trial)

N/A

Waitlist Available

Led By Jasmohan S Bajaj, MD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

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

Must have

Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

HEROIC Trial Summary

This trial will compare the effectiveness of two digital tools (PatientBuddy and EncephalApp) for preventing avoidable 30-day readmissions in patients with cirrhosis and their caregivers, compared to standard care.

Who is the study for?

This trial is for adult caregivers and cirrhosis patients aged 21 or older who live together, have been hospitalized non-electively, and consider the discharging hospital their primary healthcare provider. Caregivers must be familiar with the patient's routine and both must complete training on a health IT tool called PatientBuddy.Check my eligibility

What is being tested?

The study tests if using PatientBuddy and EncephalApp to collect patient-reported outcomes (PROs) can reduce unnecessary readmissions within 30 days after discharge compared to standard care. Participants are randomly assigned to either use these Health-IT tools with scheduled follow-ups or receive usual care without them.See study design

What are the potential side effects?

Since this trial involves Health-IT tools rather than medications, traditional side effects are not expected. However, participants may experience issues related to technology use such as stress or frustration if they find the apps difficult to use.

HEROIC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 21 with cirrhosis and have been hospitalized unexpectedly.

HEROIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Avoidable readmissions

Secondary outcome measures

All readmissions

Opinions of patients and caregivers regarding App

Readmissions related to ascites and anasarca

+2 more

HEROIC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Health IT +/- Scheduled Follow UpExperimental Treatment1 Intervention

Subjects and caregivers will be given individual phones loaded with the Patient Buddy App and the EncephalApp that will be used to enter medications, issues and orientation questions daily. There will be messages and phone calls as needed per the App and visits will be at baseline, scheduled at 15 days and at 30 days. In addition, scheduled phone calls will be performed at days 7 and 21.Follow-up will be for 30 days

Group II: Control GroupActive Control1 Intervention

Standard of care counseling and discharge instructions per local hospital policy. Standard of care follow up phone calls and visits at baseline and at 30 days. Follow-up will be for 30 days

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

697 Previous Clinical Trials

22,884,556 Total Patients Enrolled

12 Trials studying Liver Cirrhosis

2,293 Patients Enrolled for Liver Cirrhosis

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,821,908 Total Patients Enrolled

1 Trials studying Liver Cirrhosis

38 Patients Enrolled for Liver Cirrhosis

Jasmohan S Bajaj, MDPrincipal InvestigatorVCU Medical Center

7 Previous Clinical Trials

223 Total Patients Enrolled

6 Trials studying Liver Cirrhosis

193 Patients Enrolled for Liver Cirrhosis

Media Library

PatientBuddy and EncephalApp (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03564626 — N/A

Liver Cirrhosis Research Study Groups: Health IT +/- Scheduled Follow Up, Control Group

Liver Cirrhosis Clinical Trial 2023: PatientBuddy and EncephalApp Highlights & Side Effects. Trial Name: NCT03564626 — N/A

PatientBuddy and EncephalApp (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03564626 — N/A

Frequently Asked Questions

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

Are there any vacancies for this trial at the moment?

"Data on clinicaltrials.gov suggests that the recruitment phase for this medical trial has already concluded, with its first post dated June 22nd 2018 and last edited on June 1st 2022. Despite this, 461 other studies are still actively enrolling participants at present."

Answered by AI