- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301116
Promoting Seniors' Health With Home Care Aides
March 2, 2023 updated by: Naoko Muramatsu, University of Illinois at Chicago
Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
157
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- University of Illinois at Chicago
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery (SPPB)
Time Frame: Baseline, Month 4, Month 8
|
Range 0-12 (Guralnik et al., 1994)
|
Baseline, Month 4, Month 8
|
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)
|
Baseline, Month 4, Month 8
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Self-rated health
Time Frame: Baseline, Month 4, Month 8
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General self-rated health, range 1-5 (poor to excellent)
|
Baseline, Month 4, Month 8
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Pain interference
Time Frame: Baseline, Month 4, Month 8
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Interference with daily activities due to pain (not at all to extremely), range 1-5
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Baseline, Month 4, Month 8
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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).
|
Baseline, Month 4, Month 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline, Month 4, Month 8
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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
|
Baseline, Month 4, Month 8
|
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
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Baseline, Month 4, Month 8
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Physical activity levels (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics
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Baseline, Month 4, Month 8
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Falls (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)
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Baseline, Month 4, Month 8
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Ankle range of motion (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Angle between ankle dorsiflexion and plantarflexion in degrees
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Baseline, Month 4, Month 8
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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
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Baseline, Month 4, Month 8
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Pain medication usage (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Whether the participant takes pain medication (Yes/No)
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Baseline, Month 4, Month 8
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Depressive symptoms (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Feelings in the past week.
9-item scale (Yes/No), range 0-9
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Baseline, Month 4, Month 8
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NIH Toolbox Motor Battery (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Dexterity, Grip strength
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Baseline, Month 4, Month 8
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NIH Toolbox Cognition Battery (secondary outcome)
Time Frame: Baseline, Month 4, Month 8
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Baseline, Month 4, Month 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Naoko Muramatsu, PhD, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
December 7, 2022
Study Completion (Actual)
December 7, 2022
Study Registration Dates
First Submitted
September 21, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (Actual)
October 4, 2017
Study Record Updates
Last Update Posted (Estimate)
March 3, 2023
Last Update Submitted That Met QC Criteria
March 2, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0689
- R01AG053675 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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