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

Обзор

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.

Вмешательства

• Другое 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.
• Другое Study -defined standard of care
  Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge

Первичные конечные точки

• 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 [Срок оценки: within 6 weeks post-index hospital discharge]

Вторичные конечные точки (1)

• DAOH at 6 months post-discharge [Срок оценки: 6 months post-discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 16 центров

• Birmingham VA Medical Center, Birmingham, AL — Birmingham
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles
• Washington DC VA Medical Center, Washington, DC — Washington D.C.
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor
• … и ещё 8 центров

Идентификаторы

NCT: NCT05996328 · 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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