Nutritional Support for Heart Failure
(GOURMET-VA Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing if extra help with nutrition, including more dietary education and counseling, can improve recovery for patients who have just left the hospital. The goal is to see if this added support is more effective than the usual care alone.
Research Team
SL
Scott L. Hummel, MD
Principal Investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Eligibility Criteria
This trial is for Veterans aged 60+ who've been hospitalized with new or worsening heart failure, can eat and drink normally, and are enrolled in a VHA facility. It's not for those with severe dietary restrictions, kidney issues requiring dialysis, extreme obesity, cognitive impairments, or any conditions that limit their ability to control their diet or participate fully.Inclusion Criteria
I was hospitalized for at least 24 hours due to new or worsening heart failure.
Able and willing to provide informed consent and perform study activities
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)
See 2 more
Exclusion Criteria
You have very limited access to food, according to a specific screening test.
You have food allergies or intolerances that cannot be managed with the study diet.
I am on dialysis or my kidney function is very low.
See 9 more
Treatment Details
Interventions
- Home-delivered meals and short-term dietary counseling (Behavioural Intervention)
- Study-defined standard of care (Other)
Trial OverviewThe GOURMET-VA study is testing if adding home-delivered meals and short-term dietary counseling to the usual care (which includes standardized education and one dietary session post-discharge) improves outcomes for older adults with heart failure compared to usual care alone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-delivered meals and short-term dietary counselingExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Study-defined standard of care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, CT
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, MI
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Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Trials
1691
Patients Recruited
3,759,000+