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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-delivered meals and short-term dietary counseling
Study -defined standard of care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aged 60 years 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

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Home-delivered meals and short-term dietary counseling

Arm Description

Study-defined standard of care

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.

Outcomes

Primary Outcome Measures

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
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: 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. 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 Outcome Measures

DAOH at 6 months post-discharge
This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.

Full Information

First Posted
August 9, 2023
Last Updated
September 20, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05996328
Brief Title
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Acronym
GOURMET-VA
Official Title
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm study: active intervention vs study-defined standard of care
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Study-defined standard of care
Arm Title
Home-delivered meals and short-term dietary counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home-delivered meals and short-term dietary counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Study -defined standard of care
Intervention Description
study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Primary Outcome Measure Information:
Title
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
Description
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: 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. 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.
Time Frame
within 6 weeks post-index hospital discharge
Secondary Outcome Measure Information:
Title
DAOH at 6 months post-discharge
Description
This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.
Time Frame
6 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 60 years 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Huang
Phone
(203) 737-7966
Email
Yuan.Huang1@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Joyner
Phone
(203) 932-5711
Email
Shirley.Joyner@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott L. Hummel, MD
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Study Chair
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott L Hummel, MD
Email
Scott.Hummel@va.gov
First Name & Middle Initial & Last Name & Degree
Scott L. Hummel, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible

Learn more about this trial

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

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