Dementia Caregivers' Link to Assistance and Resources
DECLARE
2 other identifiers
interventional
200
1 country
1
Brief Summary
The goal of this clinical trial is to learn if the Dementia Caregivers' Link to Assistance and Resources (DECLARE) program can improve support of, and engagement with, caregivers of home health patients with dementia. DECLARE includes a caregiver self-assessment that is reported in the home health patient record, and increased access to social work for cases including dementia caregivers. The main questions we aim to answer are:
- Will most caregivers who are offered the chance to complete an assessment choose to do so?
- Will clinicians report that the assessment information was useful?
- Will the rate of social work access increase for cases with patients with dementia who have involved family caregivers? Researchers will compare DECLARE to usual care to see if taking part in the program increases caregiver self-efficacy and access to social work. Participants will:
- Answer a short series of assessment questions and questions about their caregiving experiences at the beginning of the home health episode.
- Receive a social work visit from a Licensed Social Worker trained in dementia care.
- Answer a series of follow-up questions about their caregiving experiences at the end of the home health episode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
May 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 13, 2026
March 1, 2026
12 months
February 27, 2025
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Completion rate for DECLARE caregiver assessments
A proportion. Numerator: the number of eligible caregivers who complete the DECLARE assessment. Denominator: the number of eligible caregivers who are contacted and asked to complete the DECLARE assessment at the start of the episode.
7 days
Caregiver Self-Efficacy
Caregiver self-efficacy, as measured by caregiver score on the Caregiver Self-Efficacy (CSE-4) 4-item scale developed by Merrilees, et al (2020).
60 days
Secondary Outcomes (3)
Acceptability among Clinicians
12 months
Access to Social Work
12 months
Acceptability among Caregivers
60 days
Study Arms (2)
Treatment (DECLARE)
EXPERIMENTALThe intervention for treatment branches includes two parallel processes: (1) calling eligible caregivers to field a self-assessment instrument and upload caregiver responses to the patient record, and (2) identifying and flagging cases for expedited social work access with dementia-trained social workers. Participants will also be contacted for a follow-up survey (at the end of home health care) to capture outcomes data.
Comparison (Usual care)
NO INTERVENTIONThe comparison arm will receive usual care. Eligible caregivers will be contacted via telephone to field baseline and follow-up surveys to capture outcomes data for comparison.
Interventions
The intervention for treatment branches includes two parallel processes: (1) calling eligible caregivers to field a self-assessment instrument and upload caregiver responses to the patient record, and (2) identifying and flagging cases for expedited social work access with dementia-trained social workers.
Eligibility Criteria
You may qualify if:
- Home health patient (care recipient) must have a documented dementia diagnosis on the home health assessment, be 65 years or older, and have Traditional Medicare or Medicare Advantage as their primary payer for the home health episode.
You may not qualify if:
- Caregivers are excluded if they are unable to communicate in English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VNS Health Home Care
New York, New York, 10017, United States
Related Publications (5)
Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
PMID: 11574710BACKGROUNDMerrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. Dementia (London). 2020 Aug;19(6):1955-1973. doi: 10.1177/1471301218814121. Epub 2018 Nov 29.
PMID: 30497302BACKGROUNDBurgdorf JG, Reckrey J, Russell D. "Care for Me, Too": A Novel Framework for Improved Communication and Support Between Dementia Caregivers and the Home Health Care Team. Gerontologist. 2023 Jun 15;63(5):874-886. doi: 10.1093/geront/gnac165.
PMID: 36317266BACKGROUNDBurgdorf JG, Wolff JL, Chase JA, Arbaje AI. Barriers and facilitators to family caregiver training during home health care: A multisite qualitative analysis. J Am Geriatr Soc. 2022 May;70(5):1325-1335. doi: 10.1111/jgs.17762. Epub 2022 Mar 30.
PMID: 35323993BACKGROUNDBurgdorf JG, Arbaje AI, Chase JA, Wolff JL. Current practices of family caregiver training during home health care: A qualitative study. J Am Geriatr Soc. 2022 Jan;70(1):218-227. doi: 10.1111/jgs.17492. Epub 2021 Oct 7.
PMID: 34618918BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia G Burgdorf, PhD
Center for Home Care Policy & Research, VNS Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 5, 2025
Study Start
May 5, 2025
Primary Completion
April 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Data will be gathered across the course of routine clinical care and we are requesting a waiver of initial informed consent in order to most closely mimic the "real-world" clinical environment in which the assessment would be performed. Therefore, we will not share individual participant data.