eFRIEND for Aging-Related Frailty

Overseen By Renee Woodard

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Dementia, Non-English speaking

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

2050 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves frail older adults receiving regular check-ins and support from a trained community health worker, either in person or through video calls. The goal is to help these older adults by identifying and addressing any unmet social or functional needs. Community health workers will assess their needs and provide necessary resources and assistance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications, so it's best to ask the trial coordinators for clarification.

What data supports the effectiveness of the treatment eFRIEND for aging-related frailty?

The research highlights the importance of structured frailty assessment and management, as seen in the Successful Aging and Frailty Evaluation Clinic, which suggests that systematic approaches can help manage frailty. Additionally, multicomponent frailty prevention programs have shown positive effects in older adults, indicating that comprehensive treatments like eFRIEND may be beneficial. ^{1 2 3 4 5}

How is the eFRIEND treatment different from other treatments for aging-related frailty?

The eFRIEND treatment is unique because it involves an online frailty check application that allows older adults to self-assess their frailty through a questionnaire and self-assessment of sarcopenia (muscle loss). This approach is novel as it provides a reliable and accessible way for continuous screening, especially during situations like the COVID-19 pandemic, where traditional in-person assessments may not be feasible. ^{6 7 8 9 10}

Research Team

Kathryn E. Callahan, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Eligibility Criteria

This trial is for older adults in Forsyth County, NC who are considered frail (eFI>0.21), connected to an ACO registry, have a PCP within the AHWFB system and have visited their clinic in the past year. It's not for those with dementia or non-English speakers.

Inclusion Criteria

Live in Forsyth County, NC

Frail based on the electronic Frailty Index (eFI>0.21)

Linked to any Accountable Care Organizations (ACO) registry

Exclusion Criteria

I was diagnosed with dementia in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive regularly scheduled in-person and telehealth contacts with a community health worker (CHW) as part of the eFRIEND program

6 months

Regularly scheduled in-person and telehealth contacts

Follow-up

Participants are monitored for outcomes such as food insecurity, transportation, housing instability, and social isolation

6 months

Treatment Details

Interventions

• eFRIEND

Trial Overview The eFRIEND study tests if regular visits and telehealth check-ins with a community health worker can help frail elderly people more than usual care alone by connecting them to helpful resources.

Participant Groups

Group I: Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND) Experimental Treatment 1 Intervention

Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW.

Group II: Usual Care Active Control 1 Intervention

Usual care group will be monitored passively for outcomes under a waiver of informed consent

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

A review of 12 trials involving frail older inpatients found that while many studies reported significant outcomes, there was a high risk of bias and a lack of standardized measures for frailty, which limits the reliability of the findings.

The study highlights the need for using validated frailty measurement tools and consistent health outcome reporting to improve the quality and generalizability of future research in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for frail older inpatients: A systematic review of frailty measures and reported outcomes in randomised controlled trials. King, SJ., Raine, KA., Peel, NM., et al.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Interventions for frail older inpatients: A systematic review of frailty measures and reported outcomes in randomised controlled trials. [2021]

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

Effects of a Multicomponent Frailty Prevention Program in Prefrail Community-Dwelling Older Persons: A Randomized Controlled Trial. [2021]

3. Brazil pubmed.ncbi.nlm.nih.gov

Agreement between fragility assessment instruments for older adults registered in primary health care. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Health care are associated with worsening of frailty in community older adults. [2023]

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

Translating Frailty Research Into Clinical Practice: Insights From the Successful Aging and Frailty Evaluation Clinic. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Co-Design/Co-Development and Evaluation of an Online Frailty Check Application for Older Adults: Participatory Action Research with Older Adults. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Frailty Is a Geriatric Syndrome Characterized by Multiple Impairments: A Comprehensive Approach Is Needed. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Frailty and health risks in an agricultural population, Chile 2014-2017. [2020]

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

Agreement between standard and self-reported assessments of physical frailty syndrome and its components in a registry of community-dwelling older adults. [2023]

10. Spain pubmed.ncbi.nlm.nih.gov

[Prevalence of frailty in an elderly Spanish urban population. Relationship with comorbidity and disability]. [2021]