NCT04946942

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

Completed NA Results posted Last updated 3 July 2025

What this trial tests

NA trial testing Collaborative Healthcare Encounters with Caregivers (CHEC) in Caregiver Burnout in 113 participants. Completed in 10 December 2024.

Timeline

30 August 2021

Primary endpoint
27 August 2024

10 December 2024

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	113
Start date	30 August 2021
Primary completion	27 August 2024
Estimated completion	10 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Collaborative Healthcare Encounters with Caregivers (CHEC)
• Usual Care

Conditions studied

• Caregiver Burnout — all drugs for Caregiver Burnout →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 21 to 89, any sex, with Caregiver Burnout. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Caregivers Who Complete the Checklist Primary · Through study completion, up to 1 year

The number of caregivers who complete the checklist

Group	Value	95% CI
Caregiver Checklist (CHEC)	28

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

Group	Value	95% CI
Caregiver Checklist (CHEC)	23

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

Group	Value	95% CI
Caregiver Checklist (CHEC)	25

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 Primary · 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

Group	Value	95% CI
Caregiver Checklist (CHEC)	20

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 Primary · 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

Group	Value	95% CI
Caregiver Checklist (CHEC)	22

Desire to Continue Use, as Measured by the Number Caregivers Who Report That They Desire to Continue Using the Checklist in the Future Primary · 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

Group	Value	95% CI
Caregiver Checklist (CHEC)	15

Discussion of Caregivers' Needs, as Measured by the Number of Completed Checklists That Result in a Conversation With Providers About Caregiver Needs/Concerns Primary · 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

Group	Value	95% CI
Caregiver Checklist (CHEC)	22

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Caregiver Checklist (CHEC): Caregiver

Serious: 0/29 (0%)

Deaths: 0/29

Caregiver Checklist (CHEC): Patient

Serious: 0/29 (0%)

Deaths: 0/29

Usual Care: Caregiver

Serious: 0/24 (0%)

Deaths: 0/24

Usual Care: Patient

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (1 terms — click to expand)

Reaction	System	Caregiver Checklist (CHEC)…	Caregiver Checklist (CHEC)…	Usual Care: Caregiver	Usual Care: Patient
Patient/care recipient abuse	Social circumstances	—	—	—	—

Data from ClinicalTrials.gov NCT04946942 adverse events section.

Sponsor's own description

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) accompanying Tip Sheet for clinicians.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Pilot Trial Evaluating Collaborative Healthcare Encounters With Caregivers: A Checklist-Based Intervention for Primary Care.
   Riffin C, Brody L, Wolff JL, Pillemer KA. · · 2025 · PMID 40015556 · DOI 10.1177/07334648251323688