Voice-Activated Technology to Improve Mobility & Reduce Health Disparities (EngAGE) (EngAGE)

April 19, 2024 updated by: University of Chicago

Voice-Activated Technology to Improve Mobility & Reduce Health Disparities: EngAGEing African American Older Adult-Care Partner Dyads

The purpose of this study is to test the efficacy of EngAGE (an interactive, voice-activated app) vs usual care on improving older adult physical and social function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Physical activity is essential for all age groups, across all comorbidities and geriatric syndromes; it has been described as the 'ideal' intervention for aging. Increasing physical activity among homebound, multimorbid, African American (AA) older adults (OAs) requires a shift in interventions to target the older adult-care partner (CP) pair (dyad) and to test innovative vehicles for remote intervention delivery. Our research goal is to create an evidence-based intervention that leverages technology to reach multimorbid OA-CP dyads in the home, promotes long-term mobility and social engagement among those least able to access community resources, and empowers informal care partners with tools. We developed a socially-motivated exercise tool for multimorbid OA-CP dyads called EngAGE that leverages voice-activated technology. We propose to conduct a 6-month, randomized, in-home trial of EngAGE (intervention) versus paper exercise handouts (usual care) in 124 multimorbid, homebound, AA OA-CP dyads recruited from 2 hospital systems and the community. Our overall hypothesis is that EngAGE will improve both physical and social function of older adults.

All OA subjects will undergo an in-home baseline visit where we will collect data about physical function, social function, activity and frailty. OA-CP dyads will be randomized (1:1) to a physical activity intervention: either EngAGE or usual care. All subjects will be asked to complete exercises 3-6 times per week. Care Partners will be instructed to encourage their Older Adult partner to perform physical activities on a regular basis. There is a two week Run-In Period to troubleshoot the EngAGE app and acclimate the OA subjects to the study intervention. OA subjects will be monitored via phone visits on a monthly basis. In home study visits will take place at month 3 and month 6. Data about OA subject physical function, social function, activity and frailty will be collected at these visits.

Study Type

Interventional

Enrollment (Estimated)

248

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age greater than or equal to 65 years
  • self-identifies as African American
  • has at least 2 chronic conditions
  • requires any assistance to leave the home (this may include requiring someone to drive, requiring the use of a cane or walker, or similar)
  • can read 14 point font from a 2-foot distance on a tablet-sized screen
  • can hear spoken voice from 2-foot distance
  • SPPB score of less than or equal to 8 but greater than 3 on a 12-point scale to target moderate but not severe functional impairment.

Exclusion Criteria:

  • reported history of moderate to advanced cognitive impairment;
  • inability to stand unassisted;
  • inability to understand English (because the intervention is currently only available in English);
  • life expectancy less than 12 months or enrolled in Hospice;
  • a medical condition making unsupervised physical activity potentially unsafe including: stroke within prior 12 months, acute myocardial infarction or unstable angina in the prior 6 months, uncontrolled arrhythmias, dissecting aortic aneurysm, acute endo/pericarditis, acute thromboembolism, acute or severe heart or respiratory failure, uncontrolled hypertension greater than 180/100, fracture or joint replacement within the prior 3 months, infections affecting one's general health condition, severe peripheral vascular disease.
  • severe functional impairment as indicated by an SPPB score less than 3 (out of 12);
  • baseline Montreal Cognitive Assessment of less than or equal to 18/30;
  • inability to understand consent (teach back).

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EngAGE
Older adult subjects will receive an Alexa Echo Show that runs an exercise app called EngAGE.
Behavioral: Enhanced Engagement
EngAGE will allow care partners send older adults encouragement which will be read aloud to the older adult through the EngAGE app.
Active Comparator: Physical Exercise Handouts
Older adults subjects will receive a paper booklet containing exercise instructions.
Behavioral: Standard Engagement
Care partners can encourage their older adult partner using traditional / existing communication mechanisms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Chair Stands
Time Frame: 6 months
5 repeated chair stands
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: 6 months
Dominant grip strength measured with a dynamometer, average of 3 attempts
6 months
Loneliness
Time Frame: 6 months
Measured with the 9-item UCLS loneliness scale
6 months
4 meter usual walk
Time Frame: 6 months
Participants walk 4 meters 2 times at their usual pace, fastest of 2 attempts.
6 months
Static Balance Poses
Time Frame: 6 months
Participants are asked to hold a side-by-side, semi-tandem and tandem balance pose each for 10 seconds.
6 months
Physical activity
Time Frame: 6 months
Wrist accelerometers will be worn for 7 full days in the free living environment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Rush University
National Opinion Research Center

Investigators

  • Principal Investigator: Megan Huisingh-Scheetz, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 26, 2022

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB21-1556
  • P50MD017349 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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