Voice-Activated Technology to Improve Mobility & Reduce Health Disparities (EngAGE)

Frailty Clinical Trial

— EngAGE  

Official title:

Voice-Activated Technology to Improve Mobility & Reduce Health Disparities: EngAGEing African American Older Adult-Care Partner Dyads

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337514
• Other study ID #: IRB21-1556
• Secondary ID: P50MD017349
• Status: Recruiting
• Phase: Phase 2
• Start date: October 26, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: Melanie Norstrom, PhD
• Phone: (984) 689-2992
• Email: mnorstrom[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age greater than or equal to 65 years
• self-identifies as African American
• 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 8 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).

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Enhanced Engagement
EngAGE will allow care partners send older adults encouragement which will be read aloud to the older adult through the EngAGE app.
• Standard Engagement
Care partners can encourage their older adult partner using traditional / existing communication mechanisms.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Minority Health and Health Disparities (NIMHD), National Opinion Research Center, Rush University

Country where clinical trial is conducted

United States, 

References & Publications (17)

Bendayan M, Bibas L, Levi M, Mullie L, Forman DE, Afilalo J. Therapeutic interventions for frail elderly patients: part II. Ongoing and unpublished randomized trials. Prog Cardiovasc Dis. 2014 Sep-Oct;57(2):144-51. doi: 10.1016/j.pcad.2014.07.005. Epub 20 — View Citation

Bethancourt HJ, Rosenberg DE, Beatty T, Arterburn DE. Barriers to and facilitators of physical activity program use among older adults. Clin Med Res. 2014 Sep;12(1-2):10-20. doi: 10.3121/cmr.2013.1171. Epub 2014 Jan 10. — View Citation

Corbett DB, Rejeski WJ, Tudor-Locke C, Glynn NW, Kritchevsky SB, McDermott MM, Church TS, Fielding RA, Gill TM, King AC, Miller ME, Chen H, Pahor M, Manini TM; LIFE Study Investigators. Social Participation Modifies the Effect of a Structured Physical Act — View Citation

Dunlop DD, Song J, Lee J, Gilbert AL, Semanik PA, Ehrlich-Jones L, Pellegrini CA, Pinto D, Ainsworth B, Chang RW. Physical Activity Minimum Threshold Predicting Improved Function in Adults With Lower-Extremity Symptoms. Arthritis Care Res (Hoboken). 2017 — View Citation

Fried LP. Interventions for Human Frailty: Physical Activity as a Model. Cold Spring Harb Perspect Med. 2016 Jun 1;6(6):a025916. doi: 10.1101/cshperspect.a025916. — View Citation

Gill TM, Baker DI, Gottschalk M, Peduzzi PN, Allore H, Byers A. A program to prevent functional decline in physically frail, elderly persons who live at home. N Engl J Med. 2002 Oct 3;347(14):1068-74. doi: 10.1056/NEJMoa020423. — View Citation

LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures o — View Citation

Mankowski RT, Anton SD, Axtell R, Chen SH, Fielding RA, Glynn NW, Hsu FC, King AC, Layne AS, Leeuwenburgh C, Manini TM, Marsh AP, Pahor M, Tudor-Locke C, Conroy DE, Buford TW; LIFE Research Group. Device-Measured Physical Activity As a Predictor of Disabi — View Citation

Ornstein KA, Garrido MM, Bollens-Lund E, Reckrey JM, Husain M, Ferreira KB, Liu SH, Ankuda CK, Kelley AS, Siu AL. The Association Between Income and Incident Homebound Status Among Older Medicare Beneficiaries. J Am Geriatr Soc. 2020 Nov;68(11):2594-2601. — View Citation

Ornstein KA, Leff B, Covinsky KE, Ritchie CS, Federman AD, Roberts L, Kelley AS, Siu AL, Szanton SL. Epidemiology of the Homebound Population in the United States. JAMA Intern Med. 2015 Jul;175(7):1180-6. doi: 10.1001/jamainternmed.2015.1849. Erratum In: — View Citation

Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect o — View Citation

Rogers WA, Mitzner TL. Envisioning the Future for Older Adults: Autonomy, Health, Well-being, and Social Connectedness with Technology Support. Futures. 2017 Mar;87:133-139. doi: 10.1016/j.futures.2016.07.002. Epub 2016 Jul 5. — View Citation

Saint-Maurice PF, Coughlan D, Kelly SP, Keadle SK, Cook MB, Carlson SA, Fulton JE, Matthews CE. Association of Leisure-Time Physical Activity Across the Adult Life Course With All-Cause and Cause-Specific Mortality. JAMA Netw Open. 2019 Mar 1;2(3):e190355 — View Citation

Soones T, Federman A, Leff B, Siu AL, Ornstein K. Two-Year Mortality in Homebound Older Adults: An Analysis of the National Health and Aging Trends Study. J Am Geriatr Soc. 2017 Jan;65(1):123-129. doi: 10.1111/jgs.14467. Epub 2016 Sep 19. — View Citation

Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbos — View Citation

Struck BD, Ross KM. Health promotion in older adults. Prescribing exercise for the frail and home bound. Geriatrics. 2006 May;61(5):22-7. — View Citation

Usher T, Buta B, Thorpe RJ, Huang J, Samuel LJ, Kasper JD, Bandeen-Roche K. Dissecting the Racial/Ethnic Disparity in Frailty in a Nationally Representative Cohort Study with Respect to Health, Income, and Measurement. J Gerontol A Biol Sci Med Sci. 2021 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Chair Stands	5 repeated chair stands	6 months
Secondary	Grip Strength	Dominant grip strength measured with a dynamometer, average of 3 attempts	6 months
Secondary	Loneliness	Measured with the 9-item UCLS loneliness scale	6 months
Secondary	4 meter usual walk	Participants walk 4 meters 2 times at their usual pace, fastest of 2 attempts.	6 months
Secondary	Static Balance Poses	Participants are asked to hold a side-by-side, semi-tandem and tandem balance pose each for 10 seconds.	6 months
Secondary	Physical activity	Wrist accelerometers will be worn for 7 full days in the free living environment.	6 months