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History of Changes for Study: NCT03301116
Promoting Seniors' Health With Home Care Aides
Latest version (submitted September 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 28, 2017 None (earliest Version on record)
2 October 3, 2017 Outcome Measures and Study Status
3 October 17, 2018 Study Status
4 March 9, 2020 Study Status
5 August 20, 2020 Study Status and Study Design
6 May 19, 2021 Study Status
7 March 21, 2022 Recruitment Status, Study Status and Contacts/Locations
8 September 15, 2022 Study Status
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Study NCT03301116
Submitted Date:  September 28, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2016-0689
Brief Title: Promoting Seniors' Health With Home Care Aides
Official Title: Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
Secondary IDs: R01AG053675 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: September 2017
Overall Status: Recruiting
Study Start: September 1, 2017
Primary Completion: May 31, 2020 [Anticipated]
Study Completion: April 30, 2021 [Anticipated]
First Submitted: September 21, 2017
First Submitted that
Met QC Criteria:
September 28, 2017
First Posted: October 4, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 28, 2017
Last Update Posted: October 4, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Illinois at Chicago
Responsible Party: Principal Investigator
Investigator: Naoko Muramatsu
Official Title: Associate Professor
Affiliation: University of Illinois at Chicago
Collaborators: National Institute on Aging (NIA)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Muscle Weakness
Keywords: Exercise
Frail Elderly
Homebound Persons
Activities of Daily Living
Mobility Limitation
Home Care Services
Long-Term Care
Dual MEDICAID MEDICARE Eligibility
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
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.
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module 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 ]

  1. 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)
  2. Instrumental activities of daily living (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)
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 assessed separately for family or friends, and 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 ]

Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age: 110 Years
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Central Contact Person: Naoko Muramatsu, PhD
Telephone: 312-413-0485
Email: naoko@uic.edu
Central Contact Backup: Maria Caceres, B.S.
Telephone: 312-996-6698
Email: cacemari@uic.edu
Study Officials: Naoko Muramatsu, PhD
Principal Investigator
University of Illinois at Chicago
Locations: United States, Illinois
University of Illinois at Chicago
[Recruiting]
Chicago, Illinois, United States, 60608
Contact:Contact: Maria Caceres, BS 312-996-6698 cacemari@uic.edu
Contact:Contact: Naoko Muramatsu, PhD 312-413-0485 naoko@uic.edu
Contact:Principal Investigator: Naoko Muramatsu, PhD
Contact:Sub-Investigator: Michael L. Berbaum, PhD
Contact:Sub-Investigator: David X. Marquez, PhD
Contact:Sub-Investigator: Surrey M. Walton, PhD
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
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.
URL:
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Citations:
Links:
Available IPD/Information:

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