Clinical trial NCT05337514: Voice-Activated Technology to Improve Mobility & Reduce Health Disparities (EngAGE)
Official title: Voice-Activated Technology to Improve Mobility & Reduce Health Disparities: EngAGEing Frail, Multimorbid and Homebound Older Adult-Care Partner Dyads
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Frailty
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Rush University
name: National Opinion Research Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-04-20
Enrollment: 248
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* age greater than or equal to 65 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).

Primary outcomes:
measure: Timed Chair Stands
timeFrame: 6 months
Secondary outcomes:
measure: Grip Strength
timeFrame: 6 months
measure: Loneliness
timeFrame: 6 months
measure: 4 meter usual walk
timeFrame: 6 months
measure: Static Balance Poses
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Megan Huisingh-Scheetz, MD
role: PRINCIPAL_INVESTIGATOR
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