Recruiting

DECLARE

Sponsor:

Visiting Nurse Service of New York

Code:

NCT06860035

Conditions

Alzheimer Disease or Associated Disorder

Dementia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Dementia Caregivers' Link to Assistance and Resources (DECLARE)

Study Details

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.

Conditions

Alzheimer Disease or Associated Disorder

Dementia

Study ID

NCT06860035

Start date

May 5, 2025

Status verified date

Mar, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individual must be listed as the caregiver of record for a patient receiving home health care from the partner home health agency and have a phone number on file; the patient must meet the inclusion criteria listed below.
  • 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.

Exclusion Criteria:

  • Caregivers are excluded if they are unable to communicate in English.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Treatment (DECLARE)

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. Participants will also be contacted for a follow-up survey (at the end of home health care) to capture outcomes data.

no intervention: Comparison (Usual care)

The 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

Dementia Caregivers' Link to Assistance and Resources (DECLARE)

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.

Primary outcome measure

  • Completion rate for DECLARE caregiver assessments [ Time Frame: 7 days ]
  • Caregiver Self-Efficacy [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Julia Burgdorf, PhD

(585) 406-7926julia.burgdorf@vnshealth.org

Margaret McDonald, MSW

(646) 771-5336margaret.mcdonald@vnshealth.org

Locations

VNS Health Home Care

Recruiting

New York, New York, United States, 10017

Contacts

Julia G Burgdorf, PhD

(585) 406-7926julia.burgdorf@vnshealth.org

Margaret McDonald, MSW

(646) 771-5336margaret.mcdonald@vnshealth.org

Principal Investigator:

Julia G Burgdorf, PhD

More Information

Sponsor

Visiting Nurse Service of New York

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Visiting Nurse Service of New York on 2026-03-13.