Clinical trial NCT03301116: Promoting Seniors' Health With Home Care Aides
Official title: Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-10-04
Enrollment: 157
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Exclusion Criteria

• Not having a home care client who participates in the study

Primary outcomes:
measure: Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4
timeFrame: Month 4
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, Month 4, Month 8
measure: Exercise-related social support from home care aides
timeFrame: Baseline, Month 4, Month 8
measure: Self-rated health
timeFrame: Baseline, Month 4, Month 8
measure: Pain interference
timeFrame: Baseline, Month 4, Month 8
measure: Fear of falling
timeFrame: Baseline, Month 4, Month 8
Other outcomes:
measure: Basic activities of daily living (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Activities of daily living that are specifically targeted by the intervention (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Instrumental activities of daily living (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Physical activity levels (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Falls (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Ankle range of motion (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Pain (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Pain medication usage (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: Depressive symptoms (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: NIH Toolbox Motor Battery (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
measure: NIH Toolbox Cognition Battery (secondary outcome)
timeFrame: Baseline, Month 4, Month 8
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Naoko Muramatsu, PhD
role: PRINCIPAL_INVESTIGATOR
References: