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Идёт набор NCT06586970

Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients

Без фазы С лечением Diet, Food and Nutrition Accidental Falls Cardiovascular Diseases Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Meals + RD services, Meals + OT services, Meals + RD + OT services.
Кому может быть актуально
Состояния в реестре: Diet, Food and Nutrition, Accidental Falls, Cardiovascular Diseases, Diabetes. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Randomized Controlled Trial

Обзор

The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.

Подробное описание

Home delivered meal programs provide essential health and nutritional support to community-dwelling older adults in the United States. Without this support, nearly three million older adults would be at even greater risk for malnourishment and subsequent health decline, leading to potential hospitalizations and nursing home placements. Despite the reported value of home delivered meals, the increasingly complex health needs of the older adult population warrant new, innovative approaches that enhance home-delivered meal services. In our prior work, we identified that the majority of home delivered meal clients are at high risk for malnutrition, increasing clients' risk of falling and warranting the need for registered dietitian services to attenuate health decline. Additionally, our other work has identified that 80% of home delivered meal clients are at elevated risk for falling,6 and over 40% have experienced a fall in the past year. The high prevalence of fall risk factors among home delivered clients suggests that additional services - such as occupational therapy - are also needed to optimize clients' ability to safely remain living in their own homes and communities. In response to home delivered meal clients' need for more enhanced and specialized services, the present study will test four different service models to determine which model is most effective for reducing fall-related outcomes.

Вмешательства

  • Поведенческое Meals + RD services
    Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
  • Поведенческое Meals + OT services
    Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies
  • Поведенческое Meals + RD + OT services
    A combination of tailored registered dietitian and occupational therapy services will be provided

Первичные конечные точки

  • Falls Efficacy Scale [Срок оценки: Baseline; 3-months; 6-months]
Вторичные конечные точки (3)
  • Mini Nutritional Assessment-Short Form [Срок оценки: Baseline; 3-months; 6-months]
  • Dietary intake [Срок оценки: Baseline; 3-months; 6-months]
  • EQ-5D-5L [Срок оценки: Baseline; 3-months; 6-months]

Критерии участия

Критерии включения

  • Eligible to receive meals according to LifeCare Alliance's standard in-take criteria (Over the age of 60; unable to safely and independently leave the home; does not have access to a caregiver who can prepare meals)
  • Has a working freezer to store between 7-14 frozen meals/week
  • Has a working microwave or oven to reheat meals
  • Lives within LifeCare Alliance's 5-county service area

Критерии исключения

  • Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within the past 40 days)
  • Individuals residing in residential care or a skilled nursing facility
  • Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection
  • Individuals at home on hospice care
  • Unable to independently answer LifeCare Alliance's in-take questions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • LifeCare Alliance — Columbus

Идентификаторы

NCT: NCT06586970 · 90INNU0044-01-00 · 90INNU0044-01-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗