CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
VA Office of Research and Development
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.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * aged 60 years * Veterans enrolled in a VHA facility * Hospitalized ( 24 hours) with new HF or worsening chronic HF * Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed) * Able and willing to provide informed consent and perform study activities Exclusion Criteria: * Food allergies or intolerances that cannot be accommodated by study diet * On dialysis or estimated glomerular filtration rate \<30 at randomization * Serum potassium (non-hemolyzed) \>6.0 m…
Interventions
- OtherHome-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.
- OtherStudy -defined standard of care
study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Location
- VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan