Caregiver BurnoutNCT04946942

Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study

A study testing Collaborative Healthcare Encounters with Caregivers (CHEC) in people with Caregiver Burnout, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this project is to pilot test CHEC (Collaborative Healthcare Encounters with Caregivers) in primary care. CHEC is brief intervention with two components: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older patients (aged 65+) to their primary care visits and 2)… Read more about this study

Who is it for?: Ages 21 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Caregiver Burnout
What is being tested?: Collaborative Healthcare Encounters with Caregivers (CHEC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2021to 10 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients
Age 65-89
English speaking
Women and men
Of varying race/ethnicity
Accompanied to primary care visits at the Center on Aging by a family caregiver (family caregiver also consents to participating in this study)

Show all 19Show fewer

Sufficient cognitive capacity to consent themselves or through a legal representative
Caregivers
Age 21+
English speaking
Women and men
Of varying race/ethnicity
Accompany an older adult to his or her primary care visits at the Center on Aging (Older adult also consents to participating in this study)
Cognitively intact (on basis of a 6-item cognitive screen)
Clinicians
Age 21+
Women and men
Of varying race/ethnicity
Treat patients at the Center on Aging

Who cannot join

Patients, caregivers, and clinicians that do not meet the inclusion criteria.
Patients and caregivers who are deaf or have hearing impairments that limit their ability to answer telephone queries.
Caregivers who are visually impaired and cannot see well enough to read large print and complete paper-based surveys.
Patients and/or caregivers whose dyad counterpart does not consent to take part in the study (i.e., Patients gives consent and their caregiver does not).

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

Conditions: Caregiver Burnout
Being tested: Collaborative Healthcare Encounters with Caregivers (CHEC), Usual Care
Keywords: Caregiver, Older adult, Primary care, Screening
Medical subject headings: Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Collaborative Healthcare Encounters with Caregivers (CHEC)Behavioural
CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
Usual CareBehavioural
Attendance at primary care appointments as usual.

Study groups in NCT04946942
Study group	Role	What they receive
Caregiver Checklist (CHEC)	Experimental	CHEC is composed of two elements: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older adults (aged 65+) to their primary care visits and 2) Tip Sheet for clinicians. Receives: Behavioral: Collaborative Healthcare Encounters with Caregivers (CHEC)
Usual care	Active comparator	Attendance at primary care appointments as usual. Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Caregivers Who Complete the Checklist
The number of caregivers who complete the checklist
Measured: Through study completion, up to 1 year
Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable Length
Acceptable length of CHEC, as measured by the number of caregivers who report that the checklist is an acceptable length
Measured: Post intervention, at 1 week
CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to Use
CHEC's ease of use, as measured by the number of caregivers who report that the checklist is easy to use
Measured: Post intervention, at 1 week
CHEC's Helpfulness in Identify Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Identifying Their Needs
CHEC's helpfulness in identify caregivers' needs, as measured by the number of caregivers who report that the checklist is helpful in identifying their needs
Measured: Post intervention, at 1 week
CHEC's Helpfulness in Starting a Conversation With Health Care Providers About Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Starting a Conversation With Providers About Their Needs
CHEC's helpfulness in starting a conversation with health care providers about caregivers' needs, as measured by the number of caregivers who report that the checklist is helpful in starting a conversation with providers about their needs
Measured: Post intervention, at 1 week
Desire to Continue Use, as Measured by the Number Caregivers Who Report That They Desire to Continue Using the Checklist in the Future
Desire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future
Measured: Post intervention, at 1 week
Discussion of Caregivers' Needs, as Measured by the Number of Completed Checklists That Result in a Conversation With Providers About Caregiver Needs/Concerns
Discussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns
Measured: Post intervention, at 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202110 Dec 2024

First posted1 Jul 2021
Study start30 Aug 2021
Primary completion27 Aug 2024
Study completion10 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe 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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04946942
Sponsor's protocol ID: 21-04023513
Other IDs: 5K01AG061275
Status last verified: Jun 2025
First submitted: 23 Jun 2021
Last updated: 3 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Neprash HT, Everhart A, McAlpine D, Smith LB, Sheridan B, Cross DA. Measuring Primary Care Exam Length Using Electronic Health Record Data. Med Care. 2021 Jan;59(1):62-66. doi: 10.1097/MLR.0000000000001450.
PubMed 33301282
Riffin C, Brody L, Wolff JL, Pillemer KA. A Pilot Trial Evaluating Collaborative Healthcare Encounters With Caregivers: A Checklist-Based Intervention for Primary Care. J Appl Gerontol. 2025 Dec;44(12):2006-2014. doi: 10.1177/07334648251323688. Epub 2025 Feb 27.
PubMed 40015556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Caregiver Burnout trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study
ClinicalTrials.gov ID: NCT04946942
Acronym / sponsor ID: 21-04023513
Conditions: Caregiver Burnout
Keywords: Caregiver, Older adult, Primary care, Screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 30 Aug 2021 (actual)
Primary completion: 27 Aug 2024 (actual)
Study completion: 10 Dec 2024 (actual)
First posted: 1 Jul 2021 (actual)
Results: Posted 3 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Caregiver Checklist (CHEC)	Experimental	Behavioral: Collaborative Healthcare Encounters with Caregivers (CHEC)CHEC is composed of two elements: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older adults (aged 65+) to their primary care visits and 2) Tip Sheet for clinicians.
Usual care	Active comparator	Behavioral: Usual CareAttendance at primary care appointments as usual.

Who may qualify

Ages: 21 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Patients
Age 65-89
English speaking
Women and men
Of varying race/ethnicity

Key exclusion criteria (4 listed)

Patients, caregivers, and clinicians that do not meet the inclusion criteria.
Patients and caregivers who are deaf or have hearing impairments that limit their ability to answer telephone queries.
Caregivers who are visually impaired and cannot see well enough to read large print and complete paper-based surveys.
Patients and/or caregivers whose dyad counterpart does not consent to take part in the study (i.e., Patients gives consent and their caregiver does not).

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
Collaborative Healthcare Encounters with Caregivers (CHEC)CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.	Behavioural	Caregiver Checklist (CHEC)
Usual CareAttendance at primary care appointments as usual.	Behavioural	Usual care

Primary outcome

The Number of Caregivers Who Complete the Checklist
Time frame: Through study completion, up to 1 year
The number of caregivers who complete the checklist
Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable Length
Time frame: Post intervention, at 1 week
Acceptable length of CHEC, as measured by the number of caregivers who report that the checklist is an acceptable length
CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to Use
Time frame: Post intervention, at 1 week
CHEC's ease of use, as measured by the number of caregivers who report that the checklist is easy to use
CHEC's Helpfulness in Identify Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Identifying Their Needs
Time frame: Post intervention, at 1 week
CHEC's helpfulness in identify caregivers' needs, as measured by the number of caregivers who report that the checklist is helpful in identifying their needs
CHEC's Helpfulness in Starting a Conversation With Health Care Providers About Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Starting a Conversation With Providers About Their Needs
Time frame: Post intervention, at 1 week
CHEC's helpfulness in starting a conversation with health care providers about caregivers' needs, as measured by the number of caregivers who report that the checklist is helpful in starting a conversation with providers about their needs
Desire to Continue Use, as Measured by the Number Caregivers Who Report That They Desire to Continue Using the Checklist in the Future
Time frame: Post intervention, at 1 week
Desire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future
Discussion of Caregivers' Needs, as Measured by the Number of Completed Checklists That Result in a Conversation With Providers About Caregiver Needs/Concerns
Time frame: Post intervention, at 1 week
Discussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns

Results and safety

Results posted to the registry on 3 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caregiver Checklist (CHEC)	58	52
Usual Care	48	46
Clinicians	7	7

Primary outcome: The Number of Caregivers Who Complete the Checklist

Time frame: Through study completion, up to 1 year. Count of participants. Unit: Participants

Measure	Caregiver Checklist (CHEC) n = 28	Usual Care n = 0
Value	28	–

Population analysed: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

Primary outcome: Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable Length

Time frame: Post intervention, at 1 week. Count of participants. Unit: Participants

Measure	Caregiver Checklist (CHEC) n = 28	Usual Care n = 0
Value	23	–

Population analysed: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

Primary outcome: CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to Use

Time frame: Post intervention, at 1 week. Count of participants. Unit: Participants

Measure	Caregiver Checklist (CHEC) n = 28	Usual Care n = 0
Value	25	–

Population analysed: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

Primary outcome: CHEC's Helpfulness in Identify Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Identifying Their Needs

Time frame: Post intervention, at 1 week. Count of participants. Unit: Participants

Measure	Caregiver Checklist (CHEC) n = 28	Usual Care n = 0
Value	20	–

Population analysed: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caregiver Checklist (CHEC): Caregiver	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Caregiver Checklist (CHEC): Patient	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Usual Care: Caregiver	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Usual Care: Patient	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24

Limitations and caveats (from the sponsor): As a small feasibility trial, the study was not powered to conduct multivariable analyses that account for caregiver characteristics or to evaluate treatment effects by time. Additionally, findings may not generalize to mainstream primary care practice, given that recruitment occurred at a single academic geriatrics clinic with generous appointment lengths that may have enabled greater discussion of caregiver concerns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33301282Neprash HT, Everhart A, McAlpine D, Smith LB, Sheridan B, Cross DA. Measuring Primary Care Exam Length Using Electronic Health Record Data. Med Care. 2021 Jan;59(1):62-66. doi: 10.1097/MLR.0000000000001450.
Derived from this study: PubMed 40015556Riffin C, Brody L, Wolff JL, Pillemer KA. A Pilot Trial Evaluating Collaborative Healthcare Encounters With Caregivers: A Checklist-Based Intervention for Primary Care. J Appl Gerontol. 2025 Dec;44(12):2006-2014. doi: 10.1177/07334648251323688. Epub 2025 Feb 27.
Individual participant dataSharing planned: No

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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.

Catherine Riffin, PhD principal investigator

Weill Medical College of Cornell University

Karl Pillemer, PhD principal investigator

Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Collaborative Healthcare Encounters with Caregivers (CHEC) in people with Caregiver Burnout, run by Weill Medical College of Cornell University 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 19 inclusion and 4 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 2025. 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?

Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number of Caregivers Who Complete the Checklist (time frame: Through study completion, up to 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04946942, which also lists 2 linked publications.

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 2025.