CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
NCT05996328 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400
Last updated 2026-05-07
Summary
The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.
Conditions
Interventions
- OTHER
-
Home-delivered meals and short-term dietary counseling
Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
- OTHER
-
Study -defined standard of care
study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Scott L. Hummel, MD · VA Ann Arbor Healthcare System, Ann Arbor, MI
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-15
- Primary Completion
- 2029-06-29
- Completion
- 2030-10-31
Countries
- United States
Study Locations
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