FrailtyEngAGENCT05337514
Voice-Activated Technology to Improve Mobility in Multimorbid, Frail, Homebound Older Adults (EngAGE)
A study testing Enhanced Engagement and Standard Engagement in people with Frailty, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Enhanced Engagement and Standard Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2022to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Voice-Activated Technology to Improve Mobility in Multimorbid, Frail, Homebound Older Adults: EngAGEing Older Adult-Care Partner Dyads
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.
Read the 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
- Being tested
- Enhanced Engagement, Standard Engagement
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced EngagementBehavioural
EngAGE will allow care partners send older adults encouragement which will be read aloud to the older adult through the EngAGE app.
Standard EngagementBehavioural
Care partners can encourage their older adult partner using traditional / existing communication mechanisms.
| Study group | Role | What they receive |
|---|---|---|
| EngAGE | Experimental | Older adult subjects will receive an Alexa Echo Show that runs an exercise app called EngAGE. Receives: Behavioral: Enhanced Engagement |
| Physical Exercise Handouts | Active comparator | Older adults subjects will receive a paper booklet containing exercise instructions. Receives: Behavioral: Standard Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Chair Stands
5 repeated chair stands
Measured: 6 months
Secondary outcomes (5)
Grip Strength
Dominant grip strength measured with a dynamometer, average of 3 attempts
Measured: 6 months
Loneliness
Measured with the 9-item UCLS loneliness scale
Measured: 6 months
4 meter usual walk
Participants walk 4 meters 2 times at their usual pace, fastest of 2 attempts.
Measured: 6 months
Static Balance Poses
Participants are asked to hold a side-by-side, semi-tandem and tandem balance pose each for 10 seconds.
Measured: 6 months
Physical activity
Wrist accelerometers will be worn for 7 full days in the free living environment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start26 Oct 2022
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University, National Opinion Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Megan Huisingh-Scheetz, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337514
- Sponsor's protocol ID
- IRB21-1556
- Other IDs
- P50MD017349
- Acronym
- EngAGE
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-Activated Technology to Improve Mobility in Multimorbid, Frail, Homebound Older Adults: EngAGEing Older Adult-Care Partner Dyads
- ClinicalTrials.gov ID
- NCT05337514
- Acronym / sponsor ID
- EngAGE / IRB21-1556
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Rush University, National Opinion Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EngAGE | Experimental | Behavioral: Enhanced EngagementOlder adult subjects will receive an Alexa Echo Show that runs an exercise app called EngAGE. |
| Physical Exercise Handouts | Active comparator | Behavioral: Standard EngagementOlder adults subjects will receive a paper booklet containing exercise instructions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced EngagementEngAGE will allow care partners send older adults encouragement which will be read aloud to the older adult through the EngAGE app. | Behavioural | EngAGE |
| Standard EngagementCare partners can encourage their older adult partner using traditional / existing communication mechanisms. | Behavioural | Physical Exercise Handouts |
Primary outcome
Timed Chair Stands
Time frame: 6 months
5 repeated chair stands
5 secondary outcomes
Grip Strength
Time frame: 6 months
Loneliness
Time frame: 6 months
4 meter usual walk
Time frame: 6 months
Static Balance Poses
Time frame: 6 months
Physical activity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Huisingh-Scheetz, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Engagement and Standard Engagement in people with Frailty, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Chair Stands (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.