AgingNCT05293730
Trial of the Impact of the Electronic Frailty Integrated With Social Needs
A study testing eFRIEND in people with Aging, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- eFRIEND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,050 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 12 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Frail based on the electronic Frailty Index (eFI>0.21)
- Live in Forsyth County, NC
- Linked to any Accountable Care Organizations (ACO) registry
- Have a Primary Care Provider (PCP) in Atrium Health Wake Forest Baptist (AHWFB) system, and have seen their PCP or someone else in the clinic of their PCP within the last 12 months
Who cannot join
- Diagnosis code for dementia in the past 2 years
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults
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.
Read the 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
- Aging
- Being tested
- eFRIEND, Usual Care
- Keywords
- Community Health Care Worker, elderly, assistance, at home care
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eFRIENDBehavioural
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 will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training.
Usual CareOther
Routine treatment in primary care
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND) | Experimental | Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW. Receives: Behavioral: eFRIEND |
| Usual Care | Active comparator | Usual care group will be monitored passively for outcomes under a waiver of informed consent Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ED Visits or Inpatient Hospitalizations
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Measured: Month 6
Number of ED Visits or Inpatient Hospitalizations
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Measured: Month 12
Secondary outcomes (19)
Number of Completed Medicare Annual Wellness Visits (AWVs)
Determined through data extraction from the EHR
Measured: Month 6 and Month 12
Usage of Advance Care Planning (ACP)
Total number of patients who completed ACP based on billing codes (99497 and 99498) from the EHR. The listed billing codes indicate that ACP has been completed at a patient's appointment.
Measured: Month 6 and Month 12
Acceptability of Program
Survey by clinicians at the participating sites. Mean score on the program acceptability survey Acceptability survey is comprised of the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Scores range from 12-60, with higher scores indicating greater acceptability.
Measured: Month 6 and Month 12
Participant Uptake of Home Health Services--Total Number
Care at home survey measuring if patient received home health services with yes or no answer. Total number of participants who say yes.
Measured: Month 6 and Month 12
Participant Uptake of Home Health Services--Proportion
Care at home survey measuring if patient received home health services with yes or no answer. Proportion of participants who say yes.
Measured: Month 6 and Month 12
Proportion of eligible patients who interact with CHW
Shows feasibility of patient recruitment.
Measured: Month 6 and Month 12
Number of Annual Wellness Visits (AWV)s
Measured: Month 6 and Month 12
Percentage of Participants who Report Food Insecurity--Total Number
Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Food Insecurity--Proportion
Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Housing Instability--Total Number
Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Housing Instability--Proportion
Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Lack of Transportation--Total Number
Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Lack of Transportation--Proportion
Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Use of Social Services--Total Number
Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Use of Social Services--Proportion
Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Use of Home Health Services--Total Number
Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Use of Home Health Services--Proportion
Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Social Isolation--Total Number
Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included.
Measured: Month 6 and Month 12
Percentage of Participants who Report Social Isolation--Proportion
Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included.
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start6 Sep 2022
- Primary completion12 May 2024
- Study completion12 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn E. Callahan, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293730
- Sponsor's protocol ID
- IRB00079444
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our study, is a Pragmatic Trial of the impact of the Electronic Frailty Integrated with Social Needs (eFRIEND) on high cost, high burden healthcare use of older adults in Atrium Health Wake Forest Baptist, agrees to share study data that fulfill the ICMJE requirements starting after the first 3 months after our study has started and 36 months after our first article publication. We agree to provide data to researchers who can provide our lab with a methodologically sound proposal, and who need our data to help achieve aims outlined in their proposal. The study's data will be comprised of individual participant data that underlie the results reported in our publication. Participant data will be deidentified and can be used in text, tables, figures, and appendices, after approval from the study's primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults
- ClinicalTrials.gov ID
- NCT05293730
- Acronym / sponsor ID
- IRB00079444
- Conditions
- Aging
- Keywords
- Community Health Care Worker, elderly, assistance, at home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,050 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 12 May 2024 (actual)
- Study completion
- 12 May 2024 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND) | Experimental | Behavioral: eFRIENDParticipants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW. |
| Usual Care | Active comparator | Other: Usual CareUsual care group will be monitored passively for outcomes under a waiver of informed consent |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Frail based on the electronic Frailty Index (eFI>0.21)
- Live in Forsyth County, NC
- Linked to any Accountable Care Organizations (ACO) registry
- Have a Primary Care Provider (PCP) in Atrium Health Wake Forest Baptist (AHWFB) system, and have seen their PCP or someone else in the clinic of their PCP within the last 12 months
Key exclusion criteria (2 listed)
- Diagnosis code for dementia in the past 2 years
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eFRIENDeFRIEND 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. | Behavioural | Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND) |
| Usual CareRoutine treatment in primary care | Other | Usual Care |
Primary outcome
Number of ED Visits or Inpatient Hospitalizations
Time frame: Month 6
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Number of ED Visits or Inpatient Hospitalizations
Time frame: Month 12
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
19 secondary outcomes
Number of Completed Medicare Annual Wellness Visits (AWVs)
Time frame: Month 6 and Month 12
Usage of Advance Care Planning (ACP)
Time frame: Month 6 and Month 12
Acceptability of Program
Time frame: Month 6 and Month 12
Participant Uptake of Home Health Services--Total Number
Time frame: Month 6 and Month 12
Participant Uptake of Home Health Services--Proportion
Time frame: Month 6 and Month 12
Proportion of eligible patients who interact with CHW
Time frame: Month 6 and Month 12
Number of Annual Wellness Visits (AWV)s
Time frame: Month 6 and Month 12
Percentage of Participants who Report Food Insecurity--Total Number
Time frame: Month 6 and Month 12
Percentage of Participants who Report Food Insecurity--Proportion
Time frame: Month 6 and Month 12
Percentage of Participants who Report Housing Instability--Total Number
Time frame: Month 6 and Month 12
Percentage of Participants who Report Housing Instability--Proportion
Time frame: Month 6 and Month 12
Percentage of Participants who Report Lack of Transportation--Total Number
Time frame: Month 6 and Month 12
Percentage of Participants who Report Lack of Transportation--Proportion
Time frame: Month 6 and Month 12
Percentage of Participants who Report Use of Social Services--Total Number
Time frame: Month 6 and Month 12
Percentage of Participants who Report Use of Social Services--Proportion
Time frame: Month 6 and Month 12
Percentage of Participants who Report Use of Home Health Services--Total Number
Time frame: Month 6 and Month 12
Percentage of Participants who Report Use of Home Health Services--Proportion
Time frame: Month 6 and Month 12
Percentage of Participants who Report Social Isolation--Total Number
Time frame: Month 6 and Month 12
Percentage of Participants who Report Social Isolation--Proportion
Time frame: Month 6 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes. Our study, is a Pragmatic Trial of the impact of the Electronic Frailty Integrated with Social Needs (eFRIEND) on high cost, high burden healthcare use of older adults in Atrium Health Wake Forest Baptist, agrees to share study data that fulfill the ICMJE requirements starting after the first 3 months after our study has started and 36 months after our first article publication. We agree to provide data to researchers who can provide our lab with a methodologically sound proposal, and who need our data to help achieve aims outlined in their proposal. The study's data will be comprised of individual participant data that underlie the results reported in our publication. Participant data will be deidentified and can be used in text, tables, figures, and appendices, after approval from the study's primary investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn E. Callahan, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eFRIEND in people with Aging, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ED Visits or Inpatient Hospitalizations (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.