NCT03301116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

5.3 years

First QC Date

September 21, 2017

Last Update Submit

June 24, 2025

Conditions

Keywords

ExerciseFrail ElderlyHomebound PersonsActivities of Daily LivingMobility LimitationHome Care ServicesLong-Term CareDual MEDICAID MEDICARE Eligibility

Outcome Measures

Primary Outcomes (1)

  • 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)

    Month 4

Secondary Outcomes (4)

  • Short Physical Performance Battery (SPPB)

    Baseline, Month 4, Month 8

  • Exercise-related social support from home care aides

    Baseline, Month 4, Month 8

  • Self-rated health

    Baseline, Month 4, Month 8

  • Fear of falling

    Baseline, Month 4, Month 8

Other Outcomes (8)

  • Basic activities of daily living (secondary outcome)

    Baseline, Month 4, Month 8

  • Activities of daily living that are specifically targeted by the intervention (secondary outcome)

    Baseline, Month 4, Month 8

  • Instrumental activities of daily living (secondary outcome)

    Baseline, Month 4, Month 8

  • +5 more other outcomes

Study Arms (2)

Healthy Moves

EXPERIMENTAL

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)

Active Mind

ACTIVE COMPARATOR

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)

Interventions

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.

Healthy Moves

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.

Active Mind

Eligibility Criteria

Age60 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Not having a home care client who participates in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Muscle WeaknessMotor ActivityMobility Limitation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Officials

  • Naoko Muramatsu, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
N/A (there are no other parties who will be masked in the clinical trial)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 4, 2017

Study Start

September 1, 2017

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations