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Hospital @ Home Model of Care for Cirrhosis

Study acronym: H@H
StatusRecruiting
PhaseNot applicable
Started2024-05-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 21 months later Dec 31, 2026 → Sep 30, 2028
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Indiana University

Amendment history

2026-09-23
Primary endpoint(s) modified1 to 2 entries
WasNumber of participants enrolled into program
NowNumber of participants enrolled into program, Reason for enrollment failure
Primary completion pushed: 2026-12-31 → 2028-09-30
Completion pushed: 2026-12-31 → 2028-12-31
2026-07-27
Study Status, Oversight v5
Primary completion moved earlier: 2027-12-31 → 2026-12-31
Completion moved earlier: 2027-12-31 → 2026-12-31
2025-08-14
Study Status v4
Re-verified, no change to tracked fields
2025-04-28
Study Status, Oversight, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v3
PhaseNot specified→Not applicable
Enrollment target100→30
Study arms2→1
Interventionsnot stated→Indiana University Health Hospital at Home Program (Other)
Study sitescontacts updated at 1 of 1 site
2024-06-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-06-01→confirmed 2024-05-10
Study sitesdetails revised at 1 of 1 site
2024-05-06
Study Status, Outcome Measures v1
Secondary endpoints5 entries, revised
To measure feasibilityNumber of participants with follow-up whilevisits in theduring program To measure feasibilityNumber of participants with follow-up forvisit 90 days after discharge from the program Rate of Mortality
Primary endpoints1 entry, revised
To measure feasibilityNumber of enrollmentparticipants enrolled into program
2024-04-30
Original filing
The purpose of this study is to work with patients diagnosed with end-stage liver disease to understand their perspectives on the Health at Home (H@H) Program, including desired outcomes and expectations, perceived barriers, and drivers. H@H is an emerging model of home-based care, designed to extend traditional, inpatient hospital care which may address these needs. Through H@H, acute medical care services as well as ancillary care such as rehabilitation therapy can be delivered in the home. The study is divided into three phases: Phase 1 occurs while the participant is an inpatient. Phase 2 is when the actual H@H program takes place as part of the participant's clinical care. The study team will not be involved in the Phase 2 - H@H program as it will be conducted by the clinical staff. Phase 3, at which point the participant enters a rehabilitation phase to transition the patient to self-management, involves a research jam session with the participant and caregiver to assess the value of the program.
Trial Details
NCT Number NCT06396897
Lead Sponsor Indiana University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Decompensated Cirrhosis
Enrollment 30 participants
Start Date 2024-05-10
Primary Completion 2028-09-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-22