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

NCT ID: NCT05337514

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2026-06-30

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.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

EngAGE

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

Group Type: EXPERIMENTAL

Enhanced Engagement

Intervention Type: BEHAVIORAL

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

Physical Exercise Handouts

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

Group Type: ACTIVE_COMPARATOR

Standard Engagement

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced Engagement

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

Standard Engagement

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University

OTHER

Sponsor Role: collaborator

National Opinion Research Center

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Huisingh-Scheetz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

P50MD017349

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB21-1556

Identifier Type: -

Identifier Source: org_study_id