Voice-Activated Technology to Improve Mobility & Reduce Health Disparities (EngAGE) (EngAGE)
Primary Purpose
Frailty
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhanced Engagement
Standard Engagement
Sponsored by
About this trial
This is an interventional prevention trial for Frailty
Eligibility Criteria
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).
Sites / Locations
- University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EngAGE
Physical Exercise Handouts
Arm Description
Older adult subjects will receive an Alexa Echo Show that runs an exercise app called EngAGE.
Older adults subjects will receive a paper booklet containing exercise instructions.
Outcomes
Primary Outcome Measures
Timed Chair Stands
5 repeated chair stands
Secondary Outcome Measures
Grip Strength
Dominant grip strength measured with a dynamometer, average of 3 attempts
Loneliness
Measured with the 9-item UCLS loneliness scale
4 meter usual walk
Participants walk 4 meters 2 times at their usual pace, fastest of 2 attempts.
Static Balance Poses
Participants are asked to hold a side-by-side, semi-tandem and tandem balance pose each for 10 seconds.
Physical activity
Wrist accelerometers will be worn for 7 full days in the free living environment.
Full Information
NCT ID
NCT05337514
First Posted
April 13, 2022
Last Updated
July 26, 2023
Sponsor
University of Chicago
Collaborators
Rush University, National Opinion Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT05337514
Brief Title
Voice-Activated Technology to Improve Mobility & Reduce Health Disparities (EngAGE)
Acronym
EngAGE
Official Title
Voice-Activated Technology to Improve Mobility & Reduce Health Disparities: EngAGEing African American Older Adult-Care Partner Dyads
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Rush University, National Opinion Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EngAGE
Arm Type
Experimental
Arm Description
Older adult subjects will receive an Alexa Echo Show that runs an exercise app called EngAGE.
Arm Title
Physical Exercise Handouts
Arm Type
Active Comparator
Arm Description
Older adults subjects will receive a paper booklet containing exercise instructions.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Engagement
Intervention Description
EngAGE will allow care partners send older adults encouragement which will be read aloud to the older adult through the EngAGE app.
Intervention Type
Behavioral
Intervention Name(s)
Standard Engagement
Intervention Description
Care partners can encourage their older adult partner using traditional / existing communication mechanisms.
Primary Outcome Measure Information:
Title
Timed Chair Stands
Description
5 repeated chair stands
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Grip Strength
Description
Dominant grip strength measured with a dynamometer, average of 3 attempts
Time Frame
6 months
Title
Loneliness
Description
Measured with the 9-item UCLS loneliness scale
Time Frame
6 months
Title
4 meter usual walk
Description
Participants walk 4 meters 2 times at their usual pace, fastest of 2 attempts.
Time Frame
6 months
Title
Static Balance Poses
Description
Participants are asked to hold a side-by-side, semi-tandem and tandem balance pose each for 10 seconds.
Time Frame
6 months
Title
Physical activity
Description
Wrist accelerometers will be worn for 7 full days in the free living environment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Norstrom, PhD
Phone
(984) 689-2992
Email
mnorstrom@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Huisingh-Scheetz, MD
Phone
(773) 702-8311
Email
Megan.Huisingh-Scheetz@uchospitals.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Huisingh-Scheetz, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Voice-Activated Technology to Improve Mobility & Reduce Health Disparities (EngAGE)
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