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Promoting Seniors' Health With Home Care Aides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03301116
Recruitment Status : Active, not recruiting
First Posted : October 4, 2017
Last Update Posted : September 19, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Naoko Muramatsu, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE September 21, 2017
First Posted Date  ICMJE October 4, 2017
Last Update Posted Date September 19, 2022
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, Month 4, Month 8 ]
    Range 0-12 (Guralnik et al., 1994)
  • 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)
  • Self-rated health [ Time Frame: Baseline, Month 4, Month 8 ]
    General self-rated health, range 1-5 (poor to excellent)
  • Pain interference [ Time Frame: Baseline, Month 4, Month 8 ]
    Interference with daily activities due to pain (not at all to extremely), range 1-5
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, Month 4, Month 8 ]
    Range 0-12 (Guralnik et al., 1994)
  • 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)
  • Self-rated health [ Time Frame: Baseline, Month 4, Month 8 ]
    General self-rated health, range 1-5 (poor to excellent)
  • Pain interference [ Time Frame: Baseline, Month 4, Month 8 ]
    Interference with daily activities due to pain (not at all to extremely), range 1-5
  • 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).
Current Other Pre-specified Outcome Measures
 (submitted: September 28, 2017)
  • 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)
  • 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
  • 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
  • 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
  • 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)
  • Ankle range of motion (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
    Angle between ankle dorsiflexion and plantarflexion in degrees
  • 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
  • Pain medication usage (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
    Whether the participant takes pain medication (Yes/No)
  • Depressive symptoms (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
    Feelings in the past week. 9-item scale (Yes/No), range 0-9
  • NIH Toolbox Motor Battery (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
    Dexterity, Grip strength
  • NIH Toolbox Cognition Battery (secondary outcome) [ Time Frame: Baseline, Month 4, Month 8 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Promoting Seniors' Health With Home Care Aides
Official Title  ICMJE Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Muscle Weakness
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Healthy Moves for Aging Well (Healthy Moves)
  • 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.
    Intervention: Behavioral: Active Mind for Aging Well (Active Mind)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03301116
Other Study ID Numbers  ICMJE 2016-0689
R01AG053675 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Current Responsible Party Naoko Muramatsu, University of Illinois at Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Illinois at Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Naoko Muramatsu, PhD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP