Promoting Seniors' Health With Home Care Aides

• ClinicalTrials.gov Identifier: NCT03301116
• Recruitment Status: Active, not recruiting
• First Posted: October 4, 2017
• Last Update Posted: March 23, 2022
• Sponsor: University of Illinois at Chicago
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Naoko Muramatsu, University of Illinois at Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Muscle Weakness	Behavioral: Healthy Moves for Aging Well (Healthy Moves); Behavioral: Active Mind for Aging Well (Active Mind)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: N/A (there are no other parties who will be masked in the clinical trial)
• Primary Purpose: Prevention
• Official Title: Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
• Actual Study Start Date: September 1, 2017
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: April 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Healthy Moves; Home care aides (HCAs) will be trained to deliver Healthy Moves for Aging Well (Healthy Moves), a gentle physical activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the three chair-bound moves. Home care clients will be asked to do the three moves every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period.	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 Comparator: Active Mind; Home care aides (HCAs) will be trained to deliver Active Mind for Aging Well (Active Mind), a gentle thinking activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the activity. Home care clients will be asked to do a word search puzzle every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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. Pain interference [ Time Frame: Baseline, Month 4, Month 8 ]
   Interference with daily activities due to pain (not at all to extremely), range 1-5
5. 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 Outcome Measures:

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. Pain medication usage (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
   Whether the participant takes pain medication (Yes/No)
9. Depressive symptoms (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
   Feelings in the past week. 9-item scale (Yes/No), range 0-9
10. NIH Toolbox Motor Battery (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
    Dexterity, Grip strength
11. NIH Toolbox Cognition Battery (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 110 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60608

Sponsors and Collaborators

University of Illinois at Chicago

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Naoko Muramatsu, PhD; University of Illinois at Chicago

More Information

• Responsible Party: Naoko Muramatsu, Associate Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03301116
• Other Study ID Numbers: 2016-0689; R01AG053675 ( U.S. NIH Grant/Contract )
• First Posted: October 4, 2017
• Last Update Posted: March 23, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After the end of the study, data collection instruments, codebooks, and other data documentation will be made available in conjunction with the dataset in a standard format that is readable across a variety of applications. Guidelines from relevant state agencies and collaborators will be followed.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: After the publication of the main study results
• Access Criteria: To protect participants from re-identification while retaining the analytic utility of the data, the data and associated documentation will be available to users only under a data-sharing agreement, managed by the National Archive of Computerized Data on Aging (NACDA), that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will only be released once all Institutional Review Board (IRB) approvals and human subjects concerns have been addressed.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naoko Muramatsu, University of Illinois at Chicago:

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

Additional relevant MeSH terms:

Muscle Weakness; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes