CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT05996328
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home-delivered meals and short-term dietary counseling — OTHER
    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.
  • Study -defined standard of care — OTHER
    study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jun 29, 2029
Completion
Oct 31, 2030

Study Design

Enrollment
1,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control
    Study-defined standard of care
  • Experimental: 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Scott L Hummel, MD
[email protected]
Scott L. Hummel, MD (STUDY_CHAIR)

Find similar trials in Ann Arbor, MI

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VA Ann Arbor Healthcare System, Ann Arbor, MI· Ann Arbor, MI

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