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Promoting Seniors' Health With Home Care Aides

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Moves for Aging Well (Healthy Moves)
Active Mind for Aging Well (Active Mind)
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Weakness focused on measuring Exercise, Frail Elderly, Homebound Persons, Activities of Daily Living, Mobility Limitation, Home Care Services, Long-Term Care, Dual MEDICAID MEDICARE Eligibility

Eligibility Criteria

60 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy Moves

Active Mind

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Short Physical Performance Battery (SPPB)
Range 0-12 (Guralnik et al., 1994)
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)
Self-rated health
General self-rated health, range 1-5 (poor to excellent)
Pain interference
Interference with daily activities due to pain (not at all to extremely), range 1-5
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).

Full Information

First Posted
September 21, 2017
Last Updated
March 2, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03301116
Brief Title
Promoting Seniors' Health With Home Care Aides
Official Title
Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
December 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Exercise, Frail Elderly, Homebound Persons, Activities of Daily Living, Mobility Limitation, Home Care Services, Long-Term Care, Dual MEDICAID MEDICARE Eligibility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
N/A (there are no other parties who will be masked in the clinical trial)
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naoko Muramatsu, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
After the publication of the main study results
IPD Sharing 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.

Learn more about this trial

Promoting Seniors' Health With Home Care Aides

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