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Clinical Trials/NCT03301116
NCT03301116
Completed
N/A

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

University of Illinois at Chicago1 site in 1 country157 target enrollmentSeptember 1, 2017
ConditionsMuscle Weakness

Overview

Phase
N/A
Intervention
Not specified
Conditions
Muscle Weakness
Sponsor
University of Illinois at Chicago
Enrollment
157
Locations
1
Primary Endpoint
Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
December 7, 2022
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naoko Muramatsu

Associate Professor

University of Illinois at Chicago

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4

Time Frame: Month 4

Activities 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 Outcomes

  • Short Physical Performance Battery (SPPB)(Baseline, Month 4, Month 8)
  • Exercise-related social support from home care aides(Baseline, Month 4, Month 8)
  • Self-rated health(Baseline, Month 4, Month 8)
  • Fear of falling(Baseline, Month 4, Month 8)

Study Sites (1)

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