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Direct Intervention for Liver Cirrhosis (CMH Trial)

N/A

Waitlist Available

Led By Eric Orman, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits

Awards & highlights

CMH Trial Summary

This trial will determine whether the Cirrhosis Medical Home care model, which includes a care coordinator, can improve patient outcomes.

Eligible Conditions

Liver Cirrhosis

CMH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for 6 months, at initial enrollment, 3 month, and 6 month visits for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Enrollment rate

Number of participants who dropped out

Number of participants with complete data

Secondary outcome measures

Acute Health Care Utilization

Anxiety Symptoms

CMH Interactions

+6 more

CMH Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Direct InterventionActive Control1 Intervention

Initial Evaluation: Prior to discharge, the care coordinator will review the hospital discharge plan, obtain the approval of the patient's physicians to co-manage the patient's care, and schedule a visit with the patient at their place of discharge. Participants in this arm will receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments, at least once every two weeks, will occur to continue to follow or to modify the care plan based on the needs of the patient. At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians and their participation in this study will be ended.

Group II: Standard of CarePlacebo Group1 Intervention

Prior to hospital discharge, the care coordinator will identify the primary care and/or hepatology provider of patients in the usual care group and will ensure follow up appointments at the time of hospital discharge. The coordinator will compose and send a letter to the primary care and/or hepatology provider summarizing the patient's diagnosis, hospital course, discharge medications, and the plan of follow-up care. If the patient does not already have a primary care or hepatology provider, the coordinator will work with the patient to identify a new provider. Subjects in this group will receive no further intervention.

Group III: CaregiverPlacebo Group1 Intervention

The caregivers of people with cirrhosis will be enrolled in the study. They will complete the assessments at baseline, 3 months and 6 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,415 Total Patients Enrolled

24 Trials studying Liver Cirrhosis

7,313 Patients Enrolled for Liver Cirrhosis

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,221 Total Patients Enrolled

2 Trials studying Liver Cirrhosis

236 Patients Enrolled for Liver Cirrhosis

Eric Orman, MD3.52 ReviewsPrincipal Investigator - Indiana University

Indiana University

1 Previous Clinical Trials

1,000 Total Patients Enrolled

Frequently Asked Questions

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

Are there still available slots for participants in this research endeavor?

"Clinicaltrials.gov indicates that the recruitment phase of this trial has closed since it was first posted on September 17th, 2020 and last updated November 20th 2022. Nonetheless, 461 other studies are currently seeking candidates for participation in a medical study."

Answered by AI

What are the chief aims of this experiment?

"This 2-year clinical trial is primarily focused on gauging the enrollment rate. Secondary objectives of this research endeavour include evaluating Depression Symptoms through Patient Health Questionnaire-9 (PHQ-9), assessing Health Related Quality of Life with Medical Outcome Study Short Form (SF-36), and Cognitive assessment with PHES (The Psychometric Hepatic Encephalopathy Score)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cirrhosis Medical Home

Eric Orman 2020. "Cirrhosis Medical Home". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04581369.