Aliviado DSD Program for Dementia Caregivers

Recruiting at 1 trial location

Overseen By Shih-Yin Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Blind, Deaf

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

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

Trial Summary

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Aliviado DSD Program for Dementia Caregivers is an effective treatment?

The available research shows that similar programs to the Aliviado DSD Program, like the University of California, Los Angeles Alzheimer's and Dementia Care program, have led to improvements in caregiver depression, strain, and distress related to behavioral symptoms. Although not all participants showed improvement, most caregivers found the program very beneficial due to the support and access to dementia care experts. This suggests that the Aliviado DSD Program could also be effective in providing valuable support and improving the well-being of caregivers. ^{1 2 3 4 5}

What safety data exists for the Aliviado DSD Program for Dementia Caregivers?

The provided research does not directly mention safety data for the Aliviado DSD Program or its other names. The studies focus on caregiver support programs, their implementation, and benefits, but do not specifically address safety data for the Aliviado DSD Program. ^{6 7 8 9 10}

Is the Aliviado DSD Caregiving Mastery Program a promising treatment for dementia caregivers?

Yes, the Aliviado DSD Caregiving Mastery Program is a promising treatment for dementia caregivers. It aims to improve caregivers' skills and confidence, helping them manage the challenges of caring for someone with dementia more effectively. ^{8 9 10 11 12}

What is the purpose of this trial?

Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with 30 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).

Research Team

Shih-Yin Lin

Principal Investigator

NYU Rory Meyers College of Nursing

Eligibility Criteria

This trial is for English-speaking adults who provide at least 8 hours of unpaid care weekly or live with someone with dementia at high risk for delirium. They must be unfamiliar with DSD, able to consent, and have internet access via smartphone. Blind or deaf individuals cannot participate.

Inclusion Criteria

I am over 18, speak English, care for someone with dementia without pay, don't know much about DSD, can consent, and have Internet.

Exclusion Criteria

I am not blind or deaf.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Co-design Workshop

Development of the Aliviado DSD Caregiving Mastery Program through a 5-week co-design workshop with family caregivers

5 weeks

Caregiver Education/Training

Caregiver education and training period to learn about DSD prevention, detection, and management

2 weeks

Virtual sessions

Implementation

Implementation of the Aliviado DSD Caregiving Mastery Program by family caregivers

4 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for program impact, feasibility, and acceptability

4 weeks

Treatment Details

Interventions

• Aliviado DSD Caregiving Mastery Program

Trial Overview The study tests the 'Aliviado DSD Caregiving Mastery Program,' designed to help family caregivers manage Delirium superimposed on Dementia (DSD) through a mobile health app and educational content over a 5-week workshop.

Participant Groups

Group I: Family Caregivers of PLWD at High Risk for Delirium Experimental Treatment 1 Intervention

Participants will complete the Aliviado DSD Caregiving Mastery Program. This involves a caregiver education/training period from Week 0 to Week 2, and an implementation period from Week 3 to Week 6.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

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 UCLA Alzheimer's and Dementia Care program showed overall improvements in behavioral and depressive symptoms for persons living with dementia and their caregivers after one year, despite disease progression.

A mixed-methods study identified seven areas for improvement in the program, highlighting that while some caregivers felt they did not benefit clinically, 85% still found the program very or extremely beneficial due to the supportive relationship with dementia care experts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver outcomes of a dementia care program. Evertson, LC., Jennings, LA., Reuben, DB., et al.[2022]

The one-year activity-based day care program for dementia patients showed high attendance rates (91%) and strong enthusiasm from both patients and caregivers, indicating a positive reception of the program.

Despite the high engagement, patients did not report any improvement in their quality of life, and caregivers noted an increase in behavioral disturbances among patients, suggesting that while the program was well-received, it may not have effectively addressed the patients' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an activities-based adult dementia care program. Higgins, M., Koch, K., Hynan, LS., et al.[2022]

Patients with dementia who received services from a memory clinic had more emergency department visits over 12 months compared to a matched group, but hospitalization rates were similar, indicating potential challenges in managing their health.

Caregivers reported that the educational and social support provided by the memory clinic was valuable, suggesting that the embedded dementia navigator model effectively addresses caregiver needs and may help mitigate the increasing burden as the disease progresses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Caregiver Outcomes and Experiences With Team-Based Memory Care: A Mixed Methods Study. Liu, TL., Yates, TD., Taylor, YJ., et al.[2021]

A systematic review of 24 studies on dyadic psychoeducational support programs for people with dementia and their caregivers found that tailored, goal-oriented programs significantly improve various aspects of health and quality of life for both parties.

The review highlights the importance of long-term, individualized support programs to address the progressive needs of individuals with dementia and their caregivers, suggesting that such interventions can lead to sustained positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. Ghosh, M., Dunham, M., O'Connell, B.[2023]

After 6 months in the Memory Care and Wellness Services (MCWS) program, participants with dementia showed significantly fewer depressive behaviors and a trend toward fewer overall behavior problems compared to those without access to adult day services.

Caregivers of participants in the MCWS program reported significantly less distress related to behavior problems, indicating that the program not only benefits participants but also supports caregivers, enhancing their overall satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory Care and Wellness Services: Efficacy of Specialized Dementia Care in Adult Day Services. Logsdon, RG., Pike, KC., Korte, L., 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 Savvy Advanced psychoeducation program significantly improved caregiver competence, personal gain, self-efficacy, and reduced symptoms of depression among 100 dementia family caregivers over a 12-month period, with sustained benefits observed at 12 months.

Participants reported high satisfaction with the program, indicating its perceived value, although challenges in caregiver recruitment and trainer sustainability were noted, suggesting areas for improvement in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building on Self-efficacy for Experienced Family Caregivers: The Savvy Advanced Program. Samia, LW., O'Sullivan, A., Fallon, KC., et al.[2020]

The updated Dementia Dialogues® program significantly increased caregiver knowledge about Alzheimer's disease and related dementias, as shown by a study of 235 participants from North and South Carolina.

Caregivers showed greater knowledge improvement compared to noncaregivers, indicating that the program effectively educates those directly involved in caring for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Dementia Dialogues®: A Program for Informal and Formal Caregivers in North and South Carolina. Byers, MD., Resciniti, NV., Ureña, S., et al.[2022]

A transportable psychoeducation program for family caregivers of older adults with Alzheimer's and other dementias showed significant improvements in caregiver mastery and distress after 5 to 6 months, with 52 caregivers participating in the trial.

The program's effectiveness was comparable to previous trials conducted in academic settings, indicating it can be successfully implemented in various community settings to support caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Savvy Caregiver program: the demonstrated effectiveness of a transportable dementia caregiver psychoeducation program. Hepburn, K., Lewis, M., Tornatore, J., et al.[2019]

The IHSS + ADRD Training Project is a 10-week online training program designed to improve dementia care knowledge among IHSS caregivers in Alameda County.

Preliminary results show that caregivers who completed the training experienced significant increases in their knowledge about dementia and their confidence in providing care, highlighting the need for ongoing training initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Dementia Knowledge and Self-Efficacy of In-Home Supportive Services Caregivers Through Online Training. Yeh, J., Pond, B., Beld, M., et al.[2023]

The Savvy Caregiver Program was successfully transformed from an academic-based intervention into a self-contained program, showing feasibility for adoption in various locations, as tested in rural Minnesota, Colorado, and Alaska.

Participants reported significant improvements in their skills, knowledge, and confidence as caregivers, along with reduced self-reported burden and better emotional responses towards those they care for, indicating enhanced caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The savvy caregiver program: developing and testing a transportable dementia family caregiver training program. Hepburn, KW., Lewis, M., Sherman, CW., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Dementia carer education and patient behaviour disturbance. [2006]

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

Caregiver outcomes of a dementia care program. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of an activities-based adult dementia care program. [2022]

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

Patient and Caregiver Outcomes and Experiences With Team-Based Memory Care: A Mixed Methods Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. [2023]

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

Memory Care and Wellness Services: Efficacy of Specialized Dementia Care in Adult Day Services. [2022]

7. 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]

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

Building on Self-efficacy for Experienced Family Caregivers: The Savvy Advanced Program. [2020]

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

An Evaluation of Dementia Dialogues®: A Program for Informal and Formal Caregivers in North and South Carolina. [2022]

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

The Savvy Caregiver program: the demonstrated effectiveness of a transportable dementia caregiver psychoeducation program. [2019]

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

Enhancing Dementia Knowledge and Self-Efficacy of In-Home Supportive Services Caregivers Through Online Training. [2023]

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

The savvy caregiver program: developing and testing a transportable dementia family caregiver training program. [2022]