Voice-Activated Technology to Improve Mobility in Multimorbid, Frail, Homebound Older Adults (EngAGE)

NCT05337514 | Active Not Recruiting DMC

• 2 other identifiers: IRB21-1556P50MD017349
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• Timed Chair Stands

  5 repeated chair stands

  6 months

Secondary Outcomes (5)

• Grip Strength

  6 months

• Loneliness

  6 months

• 4 meter usual walk

  6 months

• Static Balance Poses

  6 months

• Physical activity

  6 months

Study Arms (2)

EngAGE

EXPERIMENTAL

Older adult subjects will receive an Alexa Echo Show that runs an exercise app called EngAGE.

Behavioral: Enhanced Engagement

Physical Exercise Handouts

ACTIVE COMPARATOR

Older adults subjects will receive a paper booklet containing exercise instructions.

Behavioral: Standard Engagement

Interventions

Standard Engagement BEHAVIORAL

Care partners can encourage their older adult partner using traditional / existing communication mechanisms.

Physical Exercise Handouts

Enhanced Engagement BEHAVIORAL

EngAGE will allow care partners send older adults encouragement which will be read aloud to the older adult through the EngAGE app.

EngAGE

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than or equal to 60 years
• 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 9 but greater than 3 on a 12-point scale to target moderate but not severe functional impairment.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Opinion Research Center: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Chicago: lead
• Rush University: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Huisingh-Scheetz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: October 26, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)