Voice-Activated Technology for Frailty

(EngAGE Trial)

Overseen By Melanie Norstrom, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Cognitive impairment, English understanding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

248 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Enhanced Engagement, EngAGE, Enhanced Engagement, Motivational Enhancement Therapy, Standard Engagement for frailty?

The research suggests that engaging older adults living with frailty and their caregivers in decision-making and care can be beneficial, as it considers their specific needs and empowers them. Additionally, using technology to monitor frailty remotely has shown positive user experiences and acceptance, indicating that similar engagement-focused treatments could be effective. ^{1 2 3 4 5}

Is voice-activated technology for frailty safe for humans?

The studies reviewed did not report any safety concerns or adverse events related to the use of technology or interventions for frailty, suggesting that these approaches are generally safe for humans. ^{3 6 7 8 9}

How does the Voice-Activated Technology for Frailty treatment differ from other treatments for frailty?

Voice-Activated Technology for Frailty is unique because it uses voice-activated systems to help manage frailty, which is different from traditional methods like exercise and nutrition programs. This approach leverages technology to provide a potentially low-cost and proactive way to monitor and manage frailty, although the evidence for its effectiveness is still developing. ^{6 7 9 10 11}

Research Team

Megan Huisingh-Scheetz, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for African American individuals aged 65 or older with at least two chronic conditions and moderate mobility issues. They must need some assistance to leave home, be able to read on a tablet screen, hear spoken voice from a distance, and have no severe cognitive impairments.

Inclusion Criteria

Can read 14 point font from a 2-foot distance on a tablet-sized screen

My physical function is moderately impaired, not severely.

I can hear someone speaking from 2 feet away.

Exclusion Criteria

Life expectancy less than 12 months or enrolled in Hospice

You have a history of significant memory or thinking problems.

I have a health condition that makes it unsafe for me to exercise alone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-In Period

Two-week period to troubleshoot the EngAGE app and acclimate participants to the study intervention

2 weeks

1 visit (in-person)

Treatment

Participants receive either the EngAGE intervention or usual care with physical exercise handouts

6 months

Monthly phone visits, in-home visits at month 3 and month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Engagement
• Standard Engagement

Trial Overview The study compares the effectiveness of EngAGE (a voice-activated app) versus usual care in improving physical and social functions of older adults. Participants will either use the app regularly or continue with their normal routines without it.

Participant Groups

Group I: EngAGE Experimental Treatment 1 Intervention

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

Group II: Physical Exercise Handouts Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

National Opinion Research Center

Collaborator

Trials

15

Recruited

251,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

In a study of 541 patients aged 70 and older with incurable cancer, those classified as frail engaged in more and higher quality conversations about aging-related concerns compared to robust patients, regardless of whether they received a geriatric assessment (GA) intervention or usual care.

The GA intervention significantly enhanced the number and quality of these conversations across all levels of frailty, indicating its effectiveness in improving communication between patients and oncologists about aging-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the association of frailty with communication about aging-related concerns between older patients with advanced cancer and their oncologists. Gilmore, N., Xu, H., Kehoe, L., et al.[2023]

Engaging older adults living with frailty and their family caregivers is crucial for improving health outcomes, as their input is often under-represented in research and health policy, despite their significant use of healthcare resources.

Flexibility in engagement strategies, such as accommodating location and timing, along with incentivizing participation, is essential to effectively involve this vulnerable population in health and social care discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Giving voice to older adults living with frailty and their family caregivers: engagement of older adults living with frailty in research, health care decision making, and in health policy. Holroyd-Leduc, J., Resin, J., Ashley, L., et al.[2022]

The CAPACITY mobile system, designed for remote monitoring of frail older adults, demonstrated high usability with an average System Usability Scale (SUS) score of 83.68 after six months, indicating that users found it easy to use.

User experience and acceptance were also positive, with high scores in the User Experience Questionnaire (UEQ) and a trend of improvement in the Technology Acceptance Model (TAM), highlighting the importance of involving end users in the design process to enhance technology for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability, User Experience, and Acceptance Evaluation of CAPACITY: A Technological Ecosystem for Remote Follow-Up of Frailty. Pérez-Rodríguez, R., Villalba-Mora, E., Valdés-Aragonés, M., et al.[2021]

In a study of 1,135 older adults, various frailty measures were assessed to determine clinically meaningful changes over one year, revealing that the frailty phenotype and FRAIL scale showed the largest changes, indicating their potential effectiveness in tracking frailty progression.

The study provides specific estimates for small and large clinically meaningful changes in frailty measures, which can help guide the selection of appropriate tools for monitoring frailty in clinical trials and healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Clinically Meaningful Changes in Measures of Frailty. Jang, IY., Jung, HW., Lee, HY., et al.[2021]

The Frailty Outcomes Consensus Project successfully established a core set of data elements and outcomes for frailty research, involving 184 participants from 25 countries through a structured Delphi consensus process.

This core set aims to standardize how frailty is measured across studies, which will enhance the ability to analyze research collectively and improve care for individuals living with frailty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An international Delphi consensus process to determine a common data element and core outcome set for frailty: FOCUS (The Frailty Outcomes Consensus Project). Prorok, JC., Williamson, PR., Shea, B., et al.[2022]

The MoveStrong program, an 8-week exercise and nutrition intervention delivered via telephone and virtual sessions, was feasible and well-accepted by older adults, with a high retention rate of 93% and adherence to sessions exceeding 80%.

Participants showed significant improvements in physical function, as evidenced by increased chair stand test scores and enhanced dietary protein intake, indicating the program's effectiveness in addressing frailty in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. Wang, E., Keller, H., Mourtzakis, M., et al.[2022]

Remote physical activity monitoring using a chest-worn accelerometer can effectively identify individuals with cognitive frailty, showing promise for early detection of cognitive decline.

In a study of 163 older adults, specific metrics like sleep patterns and physical activity behaviors were significant indicators of cognitive frailty, with a decision tree classifier achieving an area under the curve of 0.75 for accurate identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Using Wearables to Remotely Monitor Cognitive Frailty in Community-Living Older Adults: An Observational Study. Razjouyan, J., Najafi, B., Horstman, M., et al.[2021]

A 12-session high-intensity walking training (HIWT) program significantly reduced frailty and improved physical performance in five prefrail and frail older adults, with notable increases in gait speed and balance.

The intervention was safe, with no adverse events reported, and participants rated their satisfaction highly, indicating strong support for incorporating HIWT into routine care for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Impact of High-Intensity Walking Training in Frail Older Adults. Danilovich, MK., Conroy, DE., Hornby, TG.[2018]

A study involving 163 participants aged 55 and older found that daily walking speed (DWS) measured through a smartphone app is associated with frailty, with slower speeds observed in frail individuals compared to those who are robust or prefrail.

The frailty group exhibited significantly shorter step lengths, indicating that both DWS and step length can be useful indicators for assessing frailty in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between daily life walking speed and frailty measured by a smartphone application: a cross-sectional study. Kawai, H., Obuchi, S., Ejiri, M., et al.[2023]

A systematic review of 19 studies found that while information and telecommunication technologies (ICT) show promise for managing frailty in older adults, they are currently at the 'Technology Demonstration' level, meaning they are not yet fully operational in real-world settings.

The most common applications of ICT for frailty management include detection and monitoring, but there is a lack of interventional studies, indicating that more research is needed to establish effective treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and Communication Technologies for Managing Frailty: A Systematic Literature Review. Cruz, AM., Monsalve, L., Ladurner, AM., et al.[2021]

The VOCALE intervention, which involved an 8-week online community for older adults with pre-frailty and frailty, showed promising results in improving health literacy and self-efficacy among participants, with an average age of 82.7 years.

Participants actively engaged in the program, posting at least twice a week, and reported increased awareness of health management and enjoyment in learning from each other, indicating the potential effectiveness of online platforms for health promotion in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Problem Solving About Health Management: A Mixed-Methods Pilot Evaluation of a Digital Health Intervention for Older Adults With Pre-Frailty and Frailty. Chen, AT., Chu, F., Teng, AK., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating the association of frailty with communication about aging-related concerns between older patients with advanced cancer and their oncologists. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Giving voice to older adults living with frailty and their family caregivers: engagement of older adults living with frailty in research, health care decision making, and in health policy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Usability, User Experience, and Acceptance Evaluation of CAPACITY: A Technological Ecosystem for Remote Follow-Up of Frailty. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Clinically Meaningful Changes in Measures of Frailty. [2021]

5. England pubmed.ncbi.nlm.nih.gov

An international Delphi consensus process to determine a common data element and core outcome set for frailty: FOCUS (The Frailty Outcomes Consensus Project). [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Toward Using Wearables to Remotely Monitor Cognitive Frailty in Community-Living Older Adults: An Observational Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Impact of High-Intensity Walking Training in Frail Older Adults. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Association between daily life walking speed and frailty measured by a smartphone application: a cross-sectional study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Information and Communication Technologies for Managing Frailty: A Systematic Literature Review. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Promoting Problem Solving About Health Management: A Mixed-Methods Pilot Evaluation of a Digital Health Intervention for Older Adults With Pre-Frailty and Frailty. [2021]