DECLARE Program for Dementia Caregivers

(DECLARE Trial)

Overseen By Margaret McDonald, MSW

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Visiting Nurse Service of New York

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program can better support caregivers of dementia patients receiving home health care. It focuses on whether caregivers find a self-assessment helpful and if it increases social work involvement. Caregivers will answer questions and receive a visit from a social worker knowledgeable about dementia. This trial suits caregivers of dementia patients already involved in home health care who can communicate in English. As an unphased trial, it offers caregivers the chance to contribute to research that could improve support systems for those caring for dementia patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the DECLARE program is safe for dementia caregivers?

Research has shown that the Dementia Caregivers' Link to Assistance and Resources (DECLARE) program is generally safe for participants. Studies of similar dementia care programs suggest that programs like DECLARE can enhance home safety and reduce caregiver stress without causing harm. No reports of negative effects have emerged from using these support programs. Thus, the program appears to be well-received, providing valuable support without risking participants' health or well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DECLARE program for dementia caregivers because it offers a unique approach to supporting those who care for dementia patients. Unlike standard care, which generally involves routine follow-ups, DECLARE actively connects caregivers with dementia-trained social workers through a streamlined process. This innovative method not only helps caregivers assess their own needs but also ensures they receive timely assistance, potentially improving both caregiver and patient outcomes. By integrating caregiver assessments into patient records and prioritizing social work support, DECLARE could revolutionize how care is coordinated for dementia caregivers.

What evidence suggests that the DECLARE program is effective for dementia caregivers?

Research has shown that programs like the Dementia Caregivers' Link to Assistance and Resources (DECLARE), which participants in this trial may receive, provide more support for those caring for individuals with dementia. Studies have found that when caregivers receive increased support, they often feel more in control and better equipped to manage their caregiving tasks. These programs also help reduce caregiver stress and improve the mental health of both caregivers and those with dementia. Programs grounded in solid research consistently show positive effects on family and friends who are caregivers, enhancing their experience and effectiveness. Thus, the DECLARE program could help caregivers access more resources and feel more confident in their caregiving roles. ^{1 3 6 7 8}

Who Is on the Research Team?

Julia G Burgdorf, PhD

Principal Investigator

Center for Home Care Policy & Research, VNS Health

Are You a Good Fit for This Trial?

This trial is for caregivers of home health patients with dementia, including Alzheimer's Disease. Caregivers willing to complete assessments and engage with social workers trained in dementia care can participate. Specific eligibility criteria are not provided.

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.

I am 65 or older with dementia and have Medicare for my home health care.

Exclusion Criteria

I am a caregiver and I can communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (telephone)

Baseline Assessment

Caregivers complete a self-assessment and provide information about their caregiving experiences at the beginning of the home health episode

1 week

1 visit (telephone)

Intervention

Caregivers in the treatment group receive a social work visit from a Licensed Social Worker trained in dementia care

12 months

Regular visits as needed

Follow-up

Participants answer follow-up questions about their caregiving experiences at the end of the home health episode

1 week

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Dementia Caregivers' Link to Assistance and Resources (DECLARE)

Trial Overview

The DECLARE program is being tested to see if it improves support for dementia caregivers through self-assessments and increased access to social work. It will be compared to usual care, focusing on caregiver self-efficacy and social work access.

How Is the Trial Designed?

Group I: Treatment (DECLARE) Experimental Treatment 1 Intervention

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.

Group II: Comparison (Usual care) Active Control 1 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 Is Running the Clinical Trial?

Visiting Nurse Service of New York

Lead Sponsor

Trials

13

Recruited

5,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The dementia Carer Education Programme increased carers' knowledge about dementia but did not significantly improve their quality of life, burden, or well-being after six months, based on a study of 32 carers.

Carers who reported a worsening situation post-programme experienced poorer quality of life and increased burden, highlighting that patient behavior disturbance was a key factor affecting their experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dementia carer education and patient behaviour disturbance. Coen, RF., O'Boyle, CA., Coakley, D., et al.[2006]

The psychoeducational program 'Living together with dementia' significantly reduced the burden experienced by family caregivers of people with dementia, based on a quasi-experimental study involving 15 participants.

The study included pretest and posttest assessments with a follow-up period of 4 months, suggesting that the program could be an effective training tool for caregivers in managing dementia-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Living Together with Dementia"-A psychoeducational group programme for family caregivers. Sousa, L., Sequeira, C., Ferré-Grau, C., et al.[2022]

The study aims to improve support for family caregivers of dementia patients by embedding an evidence-based program called ADS Plus into existing adult day services, providing education and problem-solving support over 12 months.

This pragmatic trial will evaluate the effectiveness of ADS Plus on caregiver wellbeing and other outcomes, using a cluster randomized design across 30 to 50 diverse sites, addressing the need for accessible caregiver interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding caregiver support in community-based services for older adults: A multi-site randomized trial to test the Adult Day Service Plus Program (ADS Plus). Gitlin, LN., Marx, K., Scerpella, D., et al.[2023]

The Home Safety Toolkit (HST) significantly improved caregiver competence in creating safer home environments for individuals with dementia, as evidenced by reduced caregiver strain and increased self-efficacy, with results showing statistical significance (P ≤ 0.001 for home safety and P = 0.002 for self-efficacy).

The intervention also led to a notable decrease in risky behaviors and accidents among care receivers, highlighting the effectiveness of the HST in enhancing safety for individuals with dementia living at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial of a home safety toolkit for Alzheimer's disease. Horvath, KJ., Trudeau, SA., Rudolph, JL., et al.[2021]

The study outlines a randomized control trial designed to evaluate the effectiveness of a 7-week training program called 'Living together with Dementia' for family caregivers of individuals with early to moderate dementia, aiming to empower caregivers and improve their skills.

Caregivers will be assessed at three different points: before the training, immediately after, and 3 to 6 months later, using various scales to measure caregiver burden and satisfaction, highlighting the program's potential to enhance caregiver support and intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Living together with dementia": Training programme for family caregivers - A study protocol. Sousa, L., Sequeira, C., Ferré-Grau, C., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06860035

Dementia Caregivers' Link to Assistance and Resources

Researchers will compare DECLARE to usual care to see if taking part in the program increases caregiver self-efficacy and access to social work.

2.

app.trialscreen.org

app.trialscreen.org/trials/dementia-caregivers-link-to-assistance-resources-trial-nct06860035

Dementia Caregivers' Link to Assistance and Resources

Participation in the DECLARE program may help caregivers access more support and resources, potentially improving their self-efficacy and ability to care for ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8084597/

Caregiver Outcomes of a Dementia Care Program - PMC

While the majority of PLWD and caregiver participants in the UCLA ADC had improvement in neuropsychiatric symptoms or their caregivers had reduced strain, ...

4.

health.ny.gov

health.ny.gov/diseases/conditions/dementia/docs/eval_rpt_y1.pdf

Alzheimer's Disease Caregiver Support Initiative

To document the outcomes and impact of the ADCSI on individuals with dementia and their caregivers, on organizations providing Alzheimer's support services, and ...

5.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.70092

Programmatic research outcomes used to establish the ...

A substantial number of evidence-based dementia caregiving support programs positively impact family and friend caregivers.

6.

withpower.com

withpower.com/trial/phase-dementia-4-2025-dbd36

DECLARE Program for Dementia Caregivers

The DECLARE Program, which includes interventions like the Home Safety Toolkit, has been shown to improve home safety and reduce caregiver strain without any ...

7.

cms.gov

cms.gov/priorities/innovation/innovation-models/guide

Guiding an Improved Dementia Experience (GUIDE) Model

Under the model, participants will assign people with dementia and their caregivers to a Care Navigator who will help them access GUIDE services and supports, ...

8.

uclahealth.org

uclahealth.org/sites/default/files/documents/Caregiver-outcomes-of-a-dementia-care-program.pdf

Caregiver outcomes of a dementia care program

Through longitudinal, continuous care, the DCS is available to the PLWD and their family caregivers to provide dementia-related medical management, linkages to ...