Alzheimer Disease or Associated DisorderDECLARENCT06860035
Dementia Caregivers' Link to Assistance and Resources
A study testing Dementia Caregivers' Link to Assistance and Resources (DECLARE) in people with Alzheimer Disease or Associated Disorder and Dementia, run by Visiting Nurse Service of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease or Associated Disorder, Dementia
- What is being tested?
- Dementia Caregivers' Link to Assistance and Resources (DECLARE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Caregivers are excluded if they are unable to communicate in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VNS Health Home Care
New York, New York, 10017
Julia G Burgdorf, PhD, (585) 406-7926, julia.burgdorf@vnshealth.org
Margaret McDonald, MSW, (646) 771-5336, margaret.mcdonald@vnshealth.org
About this study
Official title: Dementia Caregivers' Link to Assistance and Resources: Supporting Caregivers of Home Health Patients With Dementia
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?
Read more
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.
Read the 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).
- Conditions
- Alzheimer Disease or Associated Disorder, Dementia
- Being tested
- Dementia Caregivers' Link to Assistance and Resources (DECLARE)
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Caregivers' Link to Assistance and Resources (DECLARE)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (DECLARE) | Experimental | 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. Receives: Other: Dementia Caregivers' Link to Assistance and Resources (DECLARE) |
| Comparison (Usual care) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 60 days
Secondary outcomes (3)
Acceptability among Clinicians
Clinician ratings (in repeated surveys across the study timeframe) of DECLARE's usefulness and relevance to clinical practice on 5-item Likert scales.
Measured: 12 months
Access to Social Work
The proportion of eligible cases who receive a social work visit, comparing the treatment to comparison arms.
Measured: 12 months
Acceptability among Caregivers
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)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start5 May 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease or Associated DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Visiting Nurse Service of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Julia G Burgdorf, PhD, Principal investigator, Center for Home Care Policy & Research, VNS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860035
- Sponsor's protocol ID
- 2298464
- Other IDs
- K01AG081502
- Acronym
- DECLARE
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 11574710Merrilees 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.
PubMed 30497302Burgdorf 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.
PubMed 36317266Burgdorf 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.
PubMed 35323993Burgdorf 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.
PubMed 34618918
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Caregivers' Link to Assistance and Resources: Supporting Caregivers of Home Health Patients With Dementia
- ClinicalTrials.gov ID
- NCT06860035
- Acronym / sponsor ID
- DECLARE / 2298464
- Conditions
- Alzheimer Disease or Associated Disorder, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Visiting Nurse Service of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (DECLARE) | Experimental | 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. 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 intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Caregivers are excluded if they are unable to communicate in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Treatment (DECLARE) |
Primary outcome
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).
3 secondary outcomes
Acceptability among Clinicians
Time frame: 12 months
Access to Social Work
Time frame: 12 months
Acceptability among Caregivers
Time frame: 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 11574710Bedard 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.
- Background: PubMed 30497302Merrilees 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.
- Background: PubMed 36317266Burgdorf 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.
- Background: PubMed 35323993Burgdorf 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.
- Background: PubMed 34618918Burgdorf 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia G Burgdorf, PhD principal investigator
Center for Home Care Policy & Research, VNS Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Caregivers' Link to Assistance and Resources (DECLARE) in people with Alzheimer Disease or Associated Disorder and Dementia, run by Visiting Nurse Service of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Burgdorf, PhD ((585) 406-7926, julia.burgdorf@vnshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate for DECLARE caregiver assessments (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.