CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,400
- Locations
- 16
- Primary Endpoint
- Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Due to the nature of the intervention, participants, dietitians, and site coordinators can't be blinded. However, the investigators and outcome assessors will be blinded
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 mmol/L during index hospitalization
- •Heart transplant or active transplant listing
- •Left ventricular assist device present or anticipated <6 months
- •Malignancy or other non-cardiac condition limiting life expectancy to <12 months
- •Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet
- •Lack of space to store food for a week or equipment to prepare food
- •Severe cognitive impairment (SLUMS score <20, or <19 if less than high school education completed)
- •Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen)
- •Body mass index >50 kg/m2
- •Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study
Arms & Interventions
Control
Study-defined standard of care
Intervention: Study -defined standard of care (Other)
Home-delivered meals and short-term dietary counseling
Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
Intervention: Home-delivered meals and short-term dietary counseling (Other)
Outcomes
Primary Outcomes
Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life
Time Frame: within 6 weeks post-index hospital discharge
All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown: 1. Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied. 2. Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5. The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.
Secondary Outcomes
- DAOH at 6 months post-discharge(6 months post-discharge)