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Behavioural Intervention
Nutritional Support for Heart Failure (GOURMET-VA Trial)
N/A
Waitlist Available
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized (24 hours) with new HF or worsening chronic HF
Aged 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-discharge
Awards & highlights
GOURMET-VA Trial Summary
This trial studies if adding nutritional support to diet advice helps improve health outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves nutritional support rather than medication, side effects may be minimal but could include potential food-related reactions based on individual tolerances. The standard of care might have its own set of risks depending on each patient's condition.
GOURMET-VA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was hospitalized for at least 24 hours due to new or worsening heart failure.
Select...
I am 60 years old or older.
GOURMET-VA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Secondary outcome measures
DAOH at 6 months post-discharge
GOURMET-VA Trial Design
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
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,305,203 Total Patients Enrolled
38 Trials studying Heart Failure
61,788 Patients Enrolled for Heart Failure
Scott L. Hummel, MDStudy ChairVA Ann Arbor Healthcare System, Ann Arbor, MI
1 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Heart Failure
81 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility 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.You don't have enough space to store food for a week or the tools to cook food.Your blood test shows very high levels of potassium.You have a mechanical heart pump or are expected to get one within the next 6 months.I was hospitalized for at least 24 hours due to new or worsening heart failure.You weigh more than 110 pounds for every 4.9 feet of your height.I will be in a place where I can't control my diet after leaving the hospital.I am 60 years old or older.I have had a heart transplant or am on the transplant list.Veterans who are receiving care at a VHA facility.My life expectancy is less than 12 months due to my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Home-delivered meals and short-term dietary counseling
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies to participate in this medical trial?
"Clinicaltrials.gov indicates that this trial, which was primarily posted on April 1st 2024 and last amended on August 9th 2023, is not presently taking partipants. However, there are 744 other medical studies actively recruiting volunteers at the present juncture."
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