<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03301116</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0689</org_study_id>
    <secondary_id>R01AG053675</secondary_id>
    <nct_id>NCT03301116</nct_id>
  </id_info>
  <brief_title>Promoting Seniors' Health With Home Care Aides</brief_title>
  <official_title>Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to test whether a safe physical activity program with a built-in motivational&#xD;
      enhancement component, performed in a seated position, preserves the function and well-being&#xD;
      of older home care clients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regular physical activity benefits older adults physically and mentally. However, the&#xD;
      availability and the evidence for physical activity programs that are safe and appropriate&#xD;
      for home-bound older adults at risk for nursing home admission are limited. The current&#xD;
      project aims to examine the effectiveness of a safe physical activity program, led by home&#xD;
      care aides who regularly help hard-to-reach older home care clients with housekeeping and&#xD;
      routine personal care services in the home. The primary aim is to test whether the safe&#xD;
      physical activity program with a built-in motivational enhancement component, performed in a&#xD;
      seated position, preserves the function and well-being of home care clients. The secondary&#xD;
      aim is to understand for whom the program is efficacious, the extent to which the program can&#xD;
      reach the target population, the extent to which participants drop out of the program, the&#xD;
      extent to which program participants maintain the behavioral change introduced by the&#xD;
      intervention, and what the program's cost-effectiveness is. Building on a pilot project that&#xD;
      demonstrated the program's feasibility in a large home care program funded by the state and&#xD;
      Medicaid, this randomized controlled trial will inform future expansion of the physical&#xD;
      activity program into real-world home care settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 7, 2022</completion_date>
  <primary_completion_date type="Actual">December 7, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>N/A (there are no other parties who will be masked in the clinical trial)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4</measure>
    <time_frame>Month 4</time_frame>
    <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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Range 0-12 (Guralnik et al., 1994)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise-related social support from home care aides</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated health</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>General self-rated health, range 1-5 (poor to excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Interference with daily activities due to pain (not at all to extremely), range 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <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).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Basic activities of daily living (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <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)</description>
  </other_outcome>
  <other_outcome>
    <measure>Activities of daily living that are specifically targeted by the intervention (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Instrumental activities of daily living (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity levels (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics</description>
  </other_outcome>
  <other_outcome>
    <measure>Falls (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)</description>
  </other_outcome>
  <other_outcome>
    <measure>Ankle range of motion (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Angle between ankle dorsiflexion and plantarflexion in degrees</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain medication usage (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Whether the participant takes pain medication (Yes/No)</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive symptoms (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Feelings in the past week. 9-item scale (Yes/No), range 0-9</description>
  </other_outcome>
  <other_outcome>
    <measure>NIH Toolbox Motor Battery (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
    <description>Dexterity, Grip strength</description>
  </other_outcome>
  <other_outcome>
    <measure>NIH Toolbox Cognition Battery (secondary outcome)</measure>
    <time_frame>Baseline, Month 4, Month 8</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Healthy Moves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Mind</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Moves for Aging Well (Healthy Moves)</intervention_name>
    <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.</description>
    <arm_group_label>Healthy Moves</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Mind for Aging Well (Active Mind)</intervention_name>
    <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.</description>
    <arm_group_label>Active Mind</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        HOME CARE CLIENTS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  English or Spanish-speaking older adults aged 60+&#xD;
&#xD;
          -  Receiving Illinois Department on Aging Community Care Program In-Home service from the&#xD;
             collaborating home care agency&#xD;
&#xD;
          -  Able to sit in a chair independently for &gt;=15 minutes (it is fine if the person needs&#xD;
             help with transferring to a chair)&#xD;
&#xD;
          -  Cognitive status sufficient to follow directions and respond to survey questions as&#xD;
             determined by the Six-Item Screener (Callahan, et al., 2002) (the instrument used in&#xD;
             the phone screening) and the Modified Mini-Mental State (3MS) Examination (the&#xD;
             instrument used in the in-home screening)&#xD;
&#xD;
          -  Willing to be assigned to either intervention program&#xD;
&#xD;
          -  Willing to have the research team notify the primary care physician of the client's&#xD;
             study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a legal guardian appointed&#xD;
&#xD;
          -  Bedridden or unable to sit in a chair independently&#xD;
&#xD;
          -  Receiving hospice care or having a terminal diagnosis&#xD;
&#xD;
          -  Self-reported inability to read large print books&#xD;
&#xD;
        HOME CARE AIDES&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  English or Spanish-speaking home care aide caring for an older home care client&#xD;
             eligible for the study&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Willing to implement the intervention program routine with their eligible client(s)&#xD;
             for the full 4 months&#xD;
&#xD;
          -  Willing to be randomly assigned to either intervention program&#xD;
&#xD;
          -  Intend to be a home care aide for the next 12 months&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        • Not having a home care client who participates in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naoko Muramatsu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Naoko Muramatsu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Frail Elderly</keyword>
  <keyword>Homebound Persons</keyword>
  <keyword>Activities of Daily Living</keyword>
  <keyword>Mobility Limitation</keyword>
  <keyword>Home Care Services</keyword>
  <keyword>Long-Term Care</keyword>
  <keyword>Dual MEDICAID MEDICARE Eligibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After the publication of the main study results</ipd_time_frame>
    <ipd_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_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03301116
org study id: 2016-0689
secondary id: R01AG053675
nct id: NCT03301116
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: N/A (there are no other parties who will be masked in the clinical trial)
measure: Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4
time frame: 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)
measure: Short Physical Performance Battery (SPPB)
time frame: Baseline, Month 4, Month 8
description: Range 0-12 (Guralnik et al., 1994)
measure: Exercise-related social support from home care aides
time frame: Baseline, Month 4, Month 8
description: Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987)
measure: Self-rated health
time frame: Baseline, Month 4, Month 8
description: General self-rated health, range 1-5 (poor to excellent)
measure: Pain interference
time frame: Baseline, Month 4, Month 8
description: Interference with daily activities due to pain (not at all to extremely), range 1-5
measure: Fear of falling
time frame: Baseline, Month 4, Month 8
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).
measure: Basic activities of daily living (secondary outcome)
time frame: Baseline, Month 4, Month 8
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)
measure: Activities of daily living that are specifically targeted by the intervention (secondary outcome)
time frame: Baseline, Month 4, Month 8
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
measure: Instrumental activities of daily living (secondary outcome)
time frame: Baseline, Month 4, Month 8
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
measure: Physical activity levels (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics
measure: Falls (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)
measure: Ankle range of motion (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: Angle between ankle dorsiflexion and plantarflexion in degrees
measure: Pain (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10
measure: Pain medication usage (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: Whether the participant takes pain medication (Yes/No)
measure: Depressive symptoms (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: Feelings in the past week. 9-item scale (Yes/No), range 0-9
measure: NIH Toolbox Motor Battery (secondary outcome)
time frame: Baseline, Month 4, Month 8
description: Dexterity, Grip strength
measure: NIH Toolbox Cognition Battery (secondary outcome)
time frame: Baseline, Month 4, Month 8
arm group label: Healthy Moves
arm group type: Experimental
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 group label: Active Mind
arm group type: Active Comparator
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: Healthy Moves for Aging Well (Healthy Moves)
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.
arm group label: Healthy Moves
intervention type: Behavioral
intervention name: Active Mind for Aging Well (Active Mind)
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.
arm group label: Active Mind
criteria: 
gender: All
minimum age: 60 Years
maximum age: 110 Years
healthy volunteers: No
last name: Naoko Muramatsu, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Naoko Muramatsu
investigator title: Associate Professor
mesh term: Muscle Weakness
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: After the publication of the main study results
ipd 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.