Clinical Trials Directory

Trials / Completed

CompletedNCT05293730

Trial of the Impact of the Electronic Frailty Integrated With Social Needs

Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,050 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

Participants in Electronic Frailty Integrated with Social Needs (eFRIEND) will randomize to receive regularly scheduled in-person and telehealth contacts with a community health worker (CHW) or continue to receive standard of care. The purpose of this research is to use CHW to help older adults because there may be some resources that could benefit them that they are not aware of or for which they need help applying.

Detailed description

The study team will conduct a pragmatic randomized pilot trial of a CHW-led hybrid in-person/telehealth program pathway (eFRIEND) for frail older adults. Using Zelen's effectiveness design, the study team will identify eligible frail older adults via the Electronic Health Record (EHR). Eligible participants will be randomized to the eFRIEND pathway or usual care. The study team will randomize 2050 older adults (1050 to eFRIEND, 1000 to usual care), with the randomization stratified by primary care clinic. Eligible participants randomized to the eFRIEND pathway will be contacted by phone to discuss study procedures and obtain verbal informed consent. eFRIEND comprises a 6-month intervention. All CHW will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training. CHW are trusted members of the community and are utilized as part of routine care to assist patients. At the first visit, the CHW will assess if the participants have any unmet social and/or functional needs (baseline survey). The frequency and amount of time of each point of contact will be at the discretion of the CHW.

Conditions

Interventions

TypeNameDescription
BEHAVIORALeFRIENDeFRIEND 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 will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training.
OTHERUsual CareRoutine treatment in primary care

Timeline

Start date
2022-09-06
Primary completion
2024-05-12
Completion
2024-05-12
First posted
2022-03-24
Last updated
2024-07-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05293730. Inclusion in this directory is not an endorsement.