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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how community health workers can assist frail older adults by offering resources and support through the eFRIEND program. Participants will either receive regular visits and calls from a health worker or continue with their usual care. The goal is to determine if this additional support enhances their daily life. It is suitable for residents of Forsyth County, NC, who are considered frail and have a doctor at Atrium Health Wake Forest Baptist. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies for frail older adults.

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 prior data suggests that the eFRIEND program is safe for older adults?

Research shows that the eFRIEND program employs community health workers (CHWs) to support older adults. These workers check in with participants either in person or through video calls. The goal is to help older adults find and use resources they might not know about or have trouble accessing.

Since this program is new and not a medication or medical procedure, specific safety data like that for drugs is unavailable. However, using CHWs in health programs is generally safe. Participants usually feel at ease with them because CHWs are trained to be supportive and understanding. No reports have linked negative effects directly to this type of program.

Overall, the program aims to improve access to resources and care, suggesting a low risk of harm to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eFRIEND program for aging-related frailty because it offers a unique blend of in-person and telehealth care led by Community Health Workers (CHWs). Unlike traditional treatments that might rely heavily on medical interventions or passive monitoring, eFRIEND focuses on regular, personalized contact, which can enhance patient engagement and outcomes. This hybrid approach is designed to be more accessible and flexible for older adults, potentially improving their quality of life and reducing frailty symptoms by providing consistent support and connection.

What evidence suggests that the eFRIEND program is effective for aging-related frailty?

This trial will compare the eFRIEND program, led by community health workers (CHWs), with usual care. Studies have shown that involving CHWs can help older adults manage frailty better. Research indicates that regular check-ins with CHWs, either in person or through video calls, connect people to resources they might not find on their own. These connections are important because they improve access to support and healthcare services. Early findings suggest that this approach may help reduce frailty by addressing both health and social needs. While more evidence is needed to confirm these benefits, the strategy shows promise in supporting older adults. ^{1 2 4 6 7}

Who Is on the Research Team?

Kathryn E. Callahan, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-aging-5-2022-32465

eFRIEND for Aging-Related Frailty · Info for Participants This trial involves frail older adults receiving regular check-ins and support from a trained community health worker, either in person or through video ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05293730

Trial of the Impact of the Electronic Frailty Integrated With ... eFRIEND is a 6-month CWH-led intervention. All CHW will be part of the research team to ensure successful recruitment and interaction with patients, and all CHW ...

3. ninercommons.charlotte.edu ninercommons.charlotte.edu/record/2727/files/Lenoir_uncc_0694D_13892.pdf

exploring the role of the electronic frailty index (efi) in AHWFB is currently piloting an intervention. (eFRIEND, NCT05293730 clinicaltrials.gov) in which community health workers connect older adults with frailty to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10961770/

The Frailty Reduction via Implementation of Exercise ... The results of the FRIEND intervention are anticipated in mid-2024, followed by the dissemination of educational materials. Acknowledgments.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05293730?keyword=%22Home%20Care%22

Trial of the Impact of the Electronic Frailty Integrated With ... Participants in Electronic Frailty Integrated with Social Needs (eFRIEND) will randomize to receive regularly scheduled in-person and telehealth contacts ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39982448/

Application of an Electronic Frailty Index to Identify High-Risk ... This eFI identified older adults at increased risk for adverse health outcomes even when data from routine primary care visits were not available.

7. researchgate.net researchgate.net/publication/379183157_The_Frailty_Reduction_via_Implementation_of_Exercise_Nutrition_and_Deprescribing_FRIEND_Trial_Study_Protocol_and_Recruitment_Results

(PDF) The Frailty Reduction via Implementation of Exercise ... Conclusions: The FRIEND trial is currently being implemented with results expected in mid-2024. This is the first trial to evaluate the ...