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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the DECLARE treatment for dementia caregivers?

Research shows that caregiver support programs, like the Adult Day Service Plus Program, which provide education, referrals, and problem-solving techniques, can improve caregiver well-being and reduce the risk of depression and burden. Additionally, caregiver training programs have been effective in providing emotional and social support, improving coping strategies, and enhancing the quality of life for caregivers. ^{1 2 3 4 5}

Is the DECLARE Program for Dementia Caregivers safe for participants?

The DECLARE Program, which includes interventions like the Home Safety Toolkit, has been shown to improve home safety and reduce caregiver strain without any reported safety issues, suggesting it is generally safe for participants. ^{6 7 8 9 10}

How is the DECLARE Program for Dementia Caregivers treatment different from other treatments for dementia caregivers?

The DECLARE Program for Dementia Caregivers is unique because it focuses on preparing caregivers to provide care after a patient with dementia is discharged home, which is not typically addressed by other programs. It emphasizes caregiver readiness and support, which can help reduce stress and improve the mental and physical health of caregivers. ^{1 11 12 13 14}

Research Team

Julia G Burgdorf, PhD

Principal Investigator

Center for Home Care Policy & Research, VNS Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Interventions supporting caregiver readiness when caring for patients with dementia following discharge home: A mixed-methods systematic review. [2022]

2. United States 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). [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effects of caregiver dementia training in caregiver-patient dyads: A randomized controlled study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Dementia carer education and patient behaviour disturbance. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

"Living Together with Dementia"-A psychoeducational group programme for family caregivers. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safe home program: a suite of technologies to support extended home care of persons with dementia. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical trial of a home safety toolkit for Alzheimer's disease. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Implementing an evidence-based caregiver intervention within an integrated healthcare system. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Caregiver competence to prevent home injury to the care recipient with dementia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Falls and Hospitalizations Among Persons With Dementia and Associated Caregiver Emotional Difficulties. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Training and support for caregivers of people with dementia: The process of culturally adapting the World Health Organization iSupport programme to Portugal. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

"Living together with dementia": Training programme for family caregivers - A study protocol. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Caring for the Caregivers: An Alzheimer Disease Research Center Call to Action. [2023]

14. England pubmed.ncbi.nlm.nih.gov

German adaptation of the Resources for Enhancing Alzheimer's Caregiver Health II: study protocol of a single-centred, randomised controlled trial. [2021]