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Completed

NCT Number: NCT03301116

Promoting Seniors' Health With Home Care Aides

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.

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Key information

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Moves for Aging Well (Healthy Moves)

Behavioral

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.

Active Mind for Aging Well (Active Mind)

Behavioral

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.

Primary outcomes

  1. 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

  1. Short Physical Performance Battery (SPPB)

    Time frame: Baseline, Month 4, Month 8

    Range 0-12 (Guralnik et al., 1994)

  2. Exercise-related social support from home care aides

    Time frame: Baseline, Month 4, Month 8

    Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987)

  3. Self-rated health

    Time frame: Baseline, Month 4, Month 8

    General self-rated health, range 1-5 (poor to excellent)

  4. Fear of falling

    Time frame: Baseline, Month 4, Month 8

    Short 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).

Other outcomes

  1. Basic activities of daily living (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    8-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)

  2. Activities of daily living that are specifically targeted by the intervention (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    6-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

  3. Instrumental activities of daily living (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    4-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

  4. Physical activity levels (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics

  5. Falls (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)

  6. Ankle range of motion (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    Angle between ankle dorsiflexion and plantarflexion in degrees

  7. Pain (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10

  8. Depressive symptoms (secondary outcome)

    Time frame: Baseline, Month 4, Month 8

    Feelings in the past week. 9-item scale (Yes/No), range 0-9

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2017
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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