Geriatric Out-of-hospital Meal Trial in Heart Failure for Veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, interventional study in veterans with heart failure aiming to see if providing home-delivered meals plus short-term dietary counseling improves outcomes beyond the study-defined standard of care, which includes dietary education and one counseling session after discharge. The study compares the added nutritional support to the standard care alone. Eligible participants are veterans hospitalized for new or worsened heart failure and able to safely consume standard meals. Key exclusions include dialysis, very high potassium, active transplant status, LVAD plans, limited life expectancy, or inability to control post-discharge diet. The trial is sponsored by the VA Office of Research and Development and conducted at several VA centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Veterans enrolled in a VHA facility
* Hospitalized (24 hours) with new heart failure (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 kilograms per meter squared (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

Where it's running

• Birmingham VA Medical Center, Birmingham, AL
  Birmingham, Alabama, United States Recruiting
• Central Arkansas Veterans Healthcare System, Little Rock, AR
  Little Rock, Arkansas, United States Recruiting
• VA Long Beach Healthcare System, Long Beach, CA
  Long Beach, California, United States Recruiting
• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Recruiting
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  West Los Angeles, California, United States Recruiting
• Washington DC VA Medical Center, Washington, DC
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Yuan Huang
• Email: Yuan.Huang1@va.gov
• Phone: (203) 737-7966

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.