Dementia Caregivers' Link to Assistance and Resources

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease or Associated Disorder; Dementia

• Registration Number: NCT06860035
• Lead Sponsor: Visiting Nurse Service of New York

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.

Detailed Description

The goal of the present study is to pilot test a novel ADRD caregiver assessment instrument, designed specifically for the HH setting, with the ultimate aims of improving caregiver self-efficacy and increasing access to social work during HH for cases involving caregivers who are experiencing high strain and/or low preparedness for caregiving. This is the Dementia Caregivers' Link to Assistance and Resources (DECLARE) program. Specific Aims include: (1) Contacting eligible caregivers to field a caregiver self-assessment and sharing caregiver responses with frontline staff in the patient record, (2) Identifying cases for social work access, and (3) Assessing the feasibility, acceptability, and impact on caregiver outcomes of the activities described in Aims 1 and 2.

This is an embedded Pragmatic Clinical Trial (ePCT) within the VNS Health home health agency. We will implement the intervention in 4 "treatment" branches (includes 8 clinical teams) and will compare to 6 "control" branches (includes 12 clinical teams). Treatment branches will receive the DECLARE intervention described in the following section and control branches will not have any intervention. In both arms, we will conduct baseline and follow-up telephone surveys with caregivers of eligible cases to gather outcomes data. We anticipate a 12-month trial, with regular analytic checkpoints to assess for potential issues and make revisions as needed.

We will identify eligible cases based on the start of care OASIS (home health patients 65 and older with diagnosed ADRD, a caregiver on record with a phone number, and payment through Traditional Medicare or a Medicare Advantage plan managed by VNS Health. Research staff will contact the caregiver of record via telephone to field the self-assessment survey. In treatment branches, caregiver responses will be entered into a secure survey platform (RedCAP) and uploaded to the patient electronic health record (HomeCare HomeBase) as a care coordination note. For cases without a social work order, the research team will either (a) contact the Clinical Field Manager to request a social work order, if none exists or (b) contact the appropriate social worker if a social work order is already in place. We anticipate 150 participants (60 from treatment branches and 90 from control branches).

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-05-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion rate for DECLARE caregiver assessments	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	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).

Secondary Outcome Measures

Name	Time	Method
Acceptability among Clinicians	12 months	Clinician ratings (in repeated surveys across the study timeframe) of DECLARE's usefulness and relevance to clinical practice on 5-item Likert scales.
Access to Social Work	12 months	The proportion of eligible cases who receive a social work visit, comparing the treatment to comparison arms.
Acceptability among Caregivers	60 days	Among caregivers in treatment arm, ratings on 5-item Likert scales of the value of the assessment and whether they would choose to complete the assessment again. (Questions fielded during follow-up surveys at the end of the home health episode)

Trial Locations

Locations (1)

VNS Health Home Care; 🇺🇸 New York, New York, United States