Promoting Seniors' Health With Home Care Aides

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301116
• Other study ID #: 2016-0689
• Secondary ID: R01AG053675
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 7, 2022

Study information

• Verified date: March 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Behavioral:
• Healthy 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.
• Active 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Basic activities of daily living (secondary outcome)	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)	Baseline, Month 4, Month 8
Other	Activities of daily living that are specifically targeted by the intervention (secondary outcome)	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	Baseline, Month 4, Month 8
Other	Instrumental activities of daily living (secondary outcome)	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	Baseline, Month 4, Month 8
Other	Physical activity levels (secondary outcome)	Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics	Baseline, Month 4, Month 8
Other	Falls (secondary outcome)	Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)	Baseline, Month 4, Month 8
Other	Ankle range of motion (secondary outcome)	Angle between ankle dorsiflexion and plantarflexion in degrees	Baseline, Month 4, Month 8
Other	Pain (secondary outcome)	A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10	Baseline, Month 4, Month 8
Other	Pain medication usage (secondary outcome)	Whether the participant takes pain medication (Yes/No)	Baseline, Month 4, Month 8
Other	Depressive symptoms (secondary outcome)	Feelings in the past week. 9-item scale (Yes/No), range 0-9	Baseline, Month 4, Month 8
Other	NIH Toolbox Motor Battery (secondary outcome)	Dexterity, Grip strength	Baseline, Month 4, Month 8
Other	NIH Toolbox Cognition Battery (secondary outcome)		Baseline, Month 4, Month 8
Primary	Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at 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)	Month 4
Secondary	Short Physical Performance Battery (SPPB)	Range 0-12 (Guralnik et al., 1994)	Baseline, Month 4, Month 8
Secondary	Exercise-related social support from home care aides	Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987)	Baseline, Month 4, Month 8
Secondary	Self-rated health	General self-rated health, range 1-5 (poor to excellent)	Baseline, Month 4, Month 8
Secondary	Pain interference	Interference with daily activities due to pain (not at all to extremely), range 1-5	Baseline, Month 4, Month 8
Secondary	Fear of falling	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).	Baseline, Month 4, Month 8