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

ConditionsDiet, Food and NutritionAccidental FallsCardiovascular DiseasesDiabetesDebilityFrailtyFunctional Disability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Meals + RD services

    Behavioral

    Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education

  • Meals + OT services

    Behavioral

    Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies

  • Meals + RD + OT services

    Behavioral

    A combination of tailored registered dietitian and occupational therapy services will be provided

Treatment groups

750 Participants
are divided into 4 treatment groups
Group A: Arm 1: Meals onlyNo intervention 0 interventions
Group B: Arm 2: Meals + RD servicesActive comparator 1 intervention
Group C: Meals + OT servicesActive comparator 1 intervention
Group D: Arm 4: Meals + RD + OT servicesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Falls Efficacy Scale

Questionnaire to assess concerns with falling during routine activities of daily living; scores range from 7-28 points with lower scores indicating a lower concern with falling

Time frame
Baseline; 3-months; 6-months

Secondary outcomes

1

Mini Nutritional Assessment-Short Form

Questionnaire to assess risk of malnutrition; scores range from 0-14 points with lower scores indicating a lower risk of malnutrition

Time frame
Baseline; 3-months; 6-months
2

Dietary intake

Four items drawn from the Summary of Diabetes Self-Care Activities questionnaire to assess quality of foods consumed; scores range from 0-28 with higher scores indicating consumption of higher quality foods

Time frame
Baseline; 3-months; 6-months
3

EQ-5D-5L

Five domain measure to assess quality of life in the areas of mobility, self-care, usual activities, pain/discomfort and anxiety/depression; scores range from 5 to 25 points with lower scores indicating better quality of life

Time frame
Baseline; 3-months; 6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

LifeCare Alliance

Collaborator

Source ClinicalTrials.gov
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