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

The University of Chicago

Status: Active, not recruiting

Conditions: Frailty

Treatments: Behavioral: Enhanced Engagement; Behavioral: Standard Engagement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05337514

P50MD017349 (U.S. NIH Grant/Contract)

IRB21-1556

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

137 participants in 2 patient groups

EngAGE

Experimental group

Description:

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

Treatment:

Behavioral: Enhanced Engagement

Physical Exercise Handouts

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Engagement