Clinical trial NCT06586970: Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients
Official title: Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Food and Nutrition
Accidental Falls
Cardiovascular Diseases
Diabetes
Debility
Frailty
Functional Disability
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: LifeCare Alliance
First posted: 2024-09-19
Enrollment: 750
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Falls Efficacy Scale
timeFrame: Baseline; 3-months; 6-months
Secondary outcomes:
measure: Mini Nutritional Assessment-Short Form
timeFrame: Baseline; 3-months; 6-months
measure: Dietary intake
timeFrame: Baseline; 3-months; 6-months
measure: EQ-5D-5L
timeFrame: Baseline; 3-months; 6-months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: LifeCare Alliance
state: Ohio
Study officials:
References: