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Promoting Seniors' Health With Home Care Aides

Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03301116
Enrollment
157
Registered
2017-10-04
Start date
2017-09-01
Completion date
2022-12-07
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness

Keywords

Exercise, Frail Elderly, Homebound Persons, Activities of Daily Living, Mobility Limitation, Home Care Services, Long-Term Care, Dual MEDICAID MEDICARE Eligibility

Brief summary

This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.

Detailed description

Regular physical activity benefits older adults physically and mentally. However, the availability and the evidence for physical activity programs that are safe and appropriate for home-bound older adults at risk for nursing home admission are limited. The current project aims to examine the effectiveness of a safe physical activity program, led by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home. The primary aim is to test whether the safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of home care clients. The secondary aim is to understand for whom the program is efficacious, the extent to which the program can reach the target population, the extent to which participants drop out of the program, the extent to which program participants maintain the behavioral change introduced by the intervention, and what the program's cost-effectiveness is. Building on a pilot project that demonstrated the program's feasibility in a large home care program funded by the state and Medicaid, this randomized controlled trial will inform future expansion of the physical activity program into real-world home care settings.

Interventions

BEHAVIORALHealthy Moves for Aging Well (Healthy Moves)

A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position. The intervention will be delivered by home care aides for their clients.

BEHAVIORALActive Mind for Aging Well (Active Mind)

A word puzzle program which consists of a brief motivational enhancement and word search activities. The intervention will be delivered by home care aides for their clients.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

N/A (there are no other parties who will be masked in the clinical trial)

Intervention model description

Home care aide-client pairs will be randomly assigned to one of two groups in parallel for the duration of the study. Home care aides will not be allowed to have multiple participating clients assigned to different groups to prevent group contamination.

Eligibility

Sex/Gender
ALL
Age
60 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

HOME CARE CLIENTS Inclusion Criteria: * English or Spanish-speaking older adults aged 60+ * Receiving Illinois Department on Aging Community Care Program In-Home service from the collaborating home care agency * Able to sit in a chair independently for \>=15 minutes (it is fine if the person needs help with transferring to a chair) * Cognitive status sufficient to follow directions and respond to survey questions as determined by the Six-Item Screener (Callahan, et al., 2002) (the instrument used in the phone screening) and the Modified Mini-Mental State (3MS) Examination (the instrument used in the in-home screening) * Willing to be assigned to either intervention program * Willing to have the research team notify the primary care physician of the client's study participation

Exclusion criteria

* Having a legal guardian appointed * Bedridden or unable to sit in a chair independently * Receiving hospice care or having a terminal diagnosis * Self-reported inability to read large print books HOME CARE AIDES Inclusion Criteria: * English or Spanish-speaking home care aide caring for an older home care client eligible for the study * Age 18 and older * Willing to implement the intervention program routine with their eligible client(s) for the full 4 months * Willing to be randomly assigned to either intervention program * Intend to be a home care aide for the next 12 months

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4Month 4Activities of daily living that are specifically targeted by the intervention (6-items scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help; summed score, range 0-12)

Secondary

MeasureTime frameDescription
Fear of fallingBaseline, Month 4, Month 8Short Falls Efficacy Scale-International (FES-I), seven items, 4-point scale (not at all worried to very worried), range 7-28 (Kempen et al., 2008).
Short Physical Performance Battery (SPPB)Baseline, Month 4, Month 8Range 0-12 (Guralnik et al., 1994)
Exercise-related social support from home care aidesBaseline, Month 4, Month 8Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987)
Self-rated healthBaseline, Month 4, Month 8General self-rated health, range 1-5 (poor to excellent)

Other

MeasureTime frameDescription
Falls (secondary outcome)Baseline, Month 4, Month 8Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)
Ankle range of motion (secondary outcome)Baseline, Month 4, Month 8Angle between ankle dorsiflexion and plantarflexion in degrees
Pain (secondary outcome)Baseline, Month 4, Month 8A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10
Depressive symptoms (secondary outcome)Baseline, Month 4, Month 8Feelings in the past week. 9-item scale (Yes/No), range 0-9
Basic activities of daily living (secondary outcome)Baseline, Month 4, Month 88-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-16 (Gill, Robinson, and Tinetti, 1998)
Activities of daily living that are specifically targeted by the intervention (secondary outcome)Baseline, Month 4, Month 86-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-12
Instrumental activities of daily living (secondary outcome)Baseline, Month 4, Month 84-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-8
Physical activity levels (secondary outcome)Baseline, Month 4, Month 8Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026