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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT05996328
Status
Recruiting
Apply to this trial

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 three 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

First listed
Aug 18, 2023
Start date
Jul 24, 2026
Status verified
Aug 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 three 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 (16)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Fadi Hage, MD
[email protected]
(20-2)9-123)
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Jennifer Ballard-Hernandez, MD
[email protected]
(71-4)9-9808
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Shriram Nallamshetty, MD
[email protected]
(65-049-000)
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Alberta Warner, MD
[email protected]
(31-0)4-0866
Washington DC VA Medical Center, Washington, DCWashington D.C.District of Columbia20422-0001
Pamela Steele, MD
[email protected]
(20-296-850)
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608-1135
Carsten Schmalfuss, MD
[email protected]
(35-2)5-6234
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Priya Kohli, MD
[email protected]
(40-432-111)
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Scott L Hummel, MD
[email protected]
Scott L. Hummel, MD (STUDY_CHAIR)
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesota55417-2309
Bradley Bart, MD
[email protected]
(61-2)4-6387
VA NY Harbor Healthcare System, New York, NYNew YorkNew York10010-5011
Sundar Natarajan, MD
[email protected]
(21-2)6-7500
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Carrie Puckett, DO
[email protected]
(50-3) -8262
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Daniel Cheeran, MD
[email protected]
(21-4) -1472
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Savitri Fedson, MD
[email protected]
(71-3)7-7300
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001
Erik Bieging, MD
[email protected]
(60-865-780)
Richmond VA Medical Center, Richmond, VARichmondVirginia23249-0001
Michael Godschalk, MD
[email protected]
(80-467-429)
William S. Middleton Memorial Veterans Hospital, Madison, WIMadisonWisconsin53705-2254
David Murray, MD
[email protected]
(60-8)2-0080

Find similar trials in Birmingham, AL

Nationwide
Heart failure trialsCardiology trialsHeart disease trials
By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, ALVA Long Beach Healthcare System, Long Beach, CA· Long Beach, CAVA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CAVA Greater Los Angeles Healthcare System, West Los Angeles, CA· West Los Angeles, CAWashington DC VA Medical Center, Washington, DC· Washington D.C., DCNorth Florida/South Georgia Veterans Health System, Gainesville, FL· Gainesville, FL

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