NCT06860035 · Visiting Nurse Service of New York
Dementia Caregivers' Link to Assistance and Resources
(DECLARE)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 measures
Completion rate for DECLARE caregiver assessments
Time frame: 7 days
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.
Caregiver Self-Efficacy
Time frame: 60 days
Caregiver self-efficacy, as measured by caregiver score on the Caregiver Self-Efficacy (CSE-4) 4-item scale developed by Merrilees, et al (2020).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations