CarePair for Dementia Caregivers

(CarePair Trial)

Overseen By Annabelle V Greenfield, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Under 18, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 2

80 Participants Needed

Trial Summary

Do I need to stop my current medications to participate in the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app for caregivers, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment CarePair for dementia caregivers?

Research shows that caregiver training programs and integrated care models can reduce caregiver burden and improve quality of life for both caregivers and dementia patients. Programs like 'Partners in Dementia Care' and the UCLA Alzheimer's and Dementia Care program have shown benefits in managing symptoms and reducing caregiver stress. ^{1 2 3 4 5}

What safety data exists for CarePair or similar treatments for dementia caregivers?

The research does not provide specific safety data for CarePair or similar treatments for dementia caregivers. ^{6 7 8 9 10}

How is the CarePair treatment for dementia caregivers different from other treatments?

CarePair is unique because it focuses on providing caregivers with an online platform that offers disease information, daily tips, and a systematic approach to managing dementia-related behaviors. This approach is designed to be more accessible and tailored to individual needs, especially during times of social isolation like the COVID-19 pandemic. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to develop and test CarePair, a mobile application-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being. The main aims of this study are: * To evaluate the feasibility and acceptability of the CarePair mobile application. * To explore the potential for CarePair to reduce feelings of depression and burden, and improve caregivers' feelings of self-efficacy. Caregiver participants will be asked to log in and use the CarePair application and complete study activities for a six-week duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up.

Research Team

Francesca Falzarano, PhD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for family caregivers of individuals with dementia. Participants should be willing to use the CarePair web application and engage in study activities over three months. Specific eligibility criteria are not provided, but typically participants must meet certain conditions related to their situation as caregivers.

Inclusion Criteria

Does not exhibit cognitive impairment (e.g., scoring below 3 on the Short Portable Mental Status Questionnaire, SPMSQ)

Able to use the internet and has internet access

Primary caregiver of a community-dwelling person with dementia (PwD)

Exclusion Criteria

Evidence of cognitive impairment

Not a primary caregiver to a community-dwelling person with dementia (PwD)

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Baseline Assessment

Caregivers are introduced to and trained in the use of the CarePair application through video tutorials, written instructions, and virtual training sessions. Baseline interviews are conducted.

1 week

1 visit (virtual)

Intervention

Caregivers use the CarePair application for six weeks, completing bi-weekly questionnaires assessing service use and satisfaction.

6 weeks

Bi-weekly virtual check-ins

Follow-up

Participants complete a follow-up survey and an optional interview to provide feedback on their experience with the CarePair application.

1 week

1 visit (virtual)

Treatment Details

Interventions

• CarePair

Trial Overview The trial is testing CarePair, a web-based platform designed to help dementia family caregivers by assessing needs and referring services. It aims to reduce caregiver stress and improve well-being through feasibility, acceptability, depression alleviation, burden reduction, and self-efficacy enhancement.

Participant Groups

Group I: CarePair Intervention Arm Experimental Treatment 1 Intervention

After completing baseline interviews, caregivers will be introduced to and trained in the use of the CarePair through video tutorials, written instructions in PDF form, and virtual training sessions via video-conferencing software as needed. They will be instructed to login to CarePair for six weeks, and complete bi-weekly short questionnaires assessing their use of services and satisfaction with services (if used). If they have not used services, they will be asked to indicate any perceived barriers with use. At the RCT's conclusion, participants will complete a follow-up survey and an optional 15-minute interview via video-conferencing to obtain quantitative and qualitative feedback about their experience. Outcomes will include pilot data on satisfaction with output of service recommendations, interaction and usability of CarePair (primary outcomes), and caregiver self-efficacy, depression and caregiver burden (secondary outcomes).

Group II: Control Arm Active Control 1 Intervention

Participants randomized to the control arm will be assigned to an attention-matching comparator consisting of access to a digital folder with general caregiving articles that are not tailored based on user needs and/or preferences. They will receive biweekly check-in emails asking about their caregiving situation, service use, and strategies they are using to address needs.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The 'Partners in Dementia Care' (PDC) program, implemented over 12 months with 148 caregivers and 84 persons with dementia, showed significant improvements in outcomes for both groups, including reduced caregiver isolation and increased confidence in caregiving.

The positive results of the PDC program in real-world settings were consistent with previous randomized controlled trials, demonstrating its effectiveness as a regular service for supporting caregivers and persons with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings From a Real-World Translation Study of the Evidence-Based "Partners in Dementia Care". Bass, DM., Hornick, T., Kunik, M., et al.[2022]

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 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]

After high-reliability training, caregivers did not significantly increase the overall number of event reports, but there was a notable decrease in clinical process error reports, indicating a potential improvement in identifying and addressing specific types of safety issues.

The study found differences in reporting patterns between day and night shifts, suggesting that factors beyond training may influence caregivers' willingness to report safety events, highlighting the need for further research into motivators for reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Use of High-Reliability Principles to Increase Error Event Reporting: A Retrospective Review. Duffey, P., Oliver, JS., Newcomb, P.[2019]

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]

References

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

A home-based training program improves caregivers' skills and dementia patients' aggressive behaviors: a randomized controlled trial. [2013]

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

"The Community That Takes Care of Itself": A Feasibility Study to Support Families Caring for a Loved One With Alzheimer Disease. [2023]

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

Findings From a Real-World Translation Study of the Evidence-Based "Partners in Dementia Care". [2022]

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

Effectiveness of Caregiver Interventions on Patient Outcomes in Adults With Dementia or Alzheimer's Disease: A Systematic Review. [2022]

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

Caregiver outcomes of a dementia care program. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Caregivers' experience of risk in dementia: the LASER-AD study. [2015]

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

Evaluating the Use of High-Reliability Principles to Increase Error Event Reporting: A Retrospective Review. [2019]

9. England pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Handover between home and respite care concerning people with dementia: An online survey. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

WeCareAdvisor, an Online Platform to Help Family Caregivers Manage Dementia-Related Behavioral Symptoms: an Efficacy Trial in the Time of COVID-19. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial. [2022]

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

Characteristics of Depressed Caregivers of Veterans With Dementia. [2015]

14. China pubmed.ncbi.nlm.nih.gov

Behavioral health characteristics of a technology-enabled sample of Alzheimer's caregivers with high caregiver burden. [2020]

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

Do caregiver interventions improve outcomes in relatives with dementia and mild cognitive impairment? A comprehensive systematic review and meta-analysis. [2022]