CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 18
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Home-delivered meals and short-term dietary counseling (Other)
Control
Study-defined standard of care
干预措施: Study -defined standard of care (Other)
结局指标
主要结局
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
时间窗: within 6 weeks post-index hospital discharge
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: 1. 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. 2. 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.
次要结局
- DAOH at 6 months post-discharge(6 months post-discharge)