Online Workshop for Family Caregivers of People with Dementia

Recruiting at 1 trial location

Overseen By Elizabeth López Macias, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Investigator discretion, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

108 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Building Better Caregivers workshop?

Research shows that structured workshops for family caregivers, like the Minnesota Family Workshop, can reduce the burden on caregivers by providing education, support, and skills training. These types of programs help caregivers manage stress and improve their caregiving skills, which suggests that the Building Better Caregivers workshop could be effective in similar ways. ^{1 2 3 4 5}

Is the Online Workshop for Family Caregivers of People with Dementia safe?

The research articles reviewed do not provide specific safety data for the Online Workshop for Family Caregivers of People with Dementia or similar programs like the Building Better Caregivers workshop. ^{6 7 8 9 10}

How is the Building Better Caregivers workshop different from other treatments for dementia caregivers?

The Building Better Caregivers workshop is unique because it is an online program specifically designed to educate and support family caregivers of people with dementia, offering multimedia resources and interactive tools that can be accessed from home, making it more convenient and accessible compared to traditional in-person support groups. ^{11 12 13 14 15}

What is the purpose of this trial?

Many family and friend caregivers of persons living with dementia experience depression, stress, and other adverse health consequences due to the responsibilities of their caregiving role. These caregivers express a desire for education and support. The overarching goal of this project is to improve education and support for caregivers of persons living with dementia so that they can take better care of themselves and also their person living with dementia. Building Better Caregivers workshop is an online, 6-week, small group workshop for family caregivers of persons living with dementia that teaches them caregiving skills and how to manage difficult emotions, stress, and other challenging aspects of caregiving. Caregivers also receive support from other caregivers and two trained workshop facilitators and a workbook to keep. The workshop uses asynchronous delivery that allows caregivers to use materials at home when they have time day or night, self-pace their learning, and chat with other caregivers through threaded discussion board conversations. In this pilot embedded pragmatic clinical trial the investigators will evaluate the workshop among 108 caregivers who receive health care in urban areas of California and rural areas of New York. To achieve the project goals the investigators will (1) determine the feasibility of identifying, enrolling, and randomizing caregivers to a workshop group or wait-list group; (2) assess the feasibility of using electronic health record data as study outcomes, including depressive symptoms of caregivers and emergency room visits and hospitalizations of their patients with dementia; and (3) determine whether caregivers complete the workshop and think it is acceptable. If this pilot trial is successful, the investigators will have the information necessary to conduct a larger study among many additional caregivers with the long-term goal of improving their health and the well-being of their person with dementia.

Research Team

Veronica Yank, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for family caregivers of persons living with dementia (PLWD) who are experiencing stress or depression. Participants must be receiving health care in urban California or rural New York and willing to engage in an online workshop.

Inclusion Criteria

Race/ethnicity: any race/ethnicity

My gender or sex does not limit my participation.

Able to read and write in English

Exclusion Criteria

Investigator discretion for clinical safety or protocol adherence reasons, e.g., potential participant who might not be able to meet the time requirements of the study (anticipating a move)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia

6 weeks

Asynchronous online participation, 2-3 logins per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of caregiver depressive symptoms survey

4 months

Wait-list Control

Participants in the wait-list control group are offered the workshop after their 3-month trial participation is completed

3 months

Treatment Details

Interventions

• Building Better Caregivers workshop

Trial Overview The 'Building Better Caregivers' workshop, a 6-week online program designed to teach caregiving skills, manage emotions and stress, is being tested. It includes support from facilitators and peers, using materials that can be accessed anytime.

Participant Groups

Group I: Workshop Experimental Treatment 1 Intervention

A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.

Group II: Control Active Control 1 Intervention

Wait-list control group.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The Minnesota Family Workshop, consisting of seven weekly sessions, effectively reduced caregiver burden for families of dementia patients by providing education, support, and skills training.

The program's design encouraged family involvement by requiring primary caregivers to bring at least one other family member, enhancing the support network for both caregivers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training family caregivers of patients with dementia. A structured workshop approach. Ostwald, SK., Hepburn, KW., Burns, T.[2019]

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]

A one-day training program significantly improved confidence in dementia care management for over 50% of family caregivers on 11 out of 12 confidence items, with notable improvements in 4 specific areas.

The training, which included interactive elements and real-world case discussions using the DICE approach, was particularly effective for family caregivers, who showed greater confidence gains compared to professional caregivers in 6 out of 12 items.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving Evidence-Informed Assessment and Management of Behavioral and Psychological Symptoms of Dementia into the Real World: Training Family and Staff Caregivers in the DICE Approach. Kales, HC., Kern, V., Kim, HM., et al.[2021]

In a study involving 43 caregiver and person-with-dementia dyads, active psychoeducational interventions significantly improved caregivers' skills and reduced their burden compared to passive interventions, as measured by various assessment tools.

The active intervention led to better outcomes in caregiver competence and distress levels after just three months, highlighting the effectiveness of engaging methods like role-play and problem-solving in caregiver training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver active participation in psychoeducational intervention improved caregiving skills and competency. Tang, SH., Chio, OI., Chang, LH., et al.[2019]

Family caregivers who are also trained nurses actively monitor and identify risks in the care of their loved ones, using their professional expertise to enhance safety.

These nurse caregivers face a dilemma when deciding whether to intervene in care situations, weighing the potential benefits and drawbacks of their actions, which can affect their willingness to disclose their professional background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

“Watchful? For sure!” – Health professionals as family carers and their roles in patient safety Jähnke, A., Liebert, Y., Käppeli, A., et al.[2019]

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]

The consensus conference developed key recommendations for improving the disclosure of adverse events to patients and their families, emphasizing the need for institutional policies and guidelines.

Training healthcare professionals in communication skills and patient safety is crucial, along with creating supportive strategies for those involved in adverse events, to foster a culture of transparency and trust in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Consensus conference on providing information of adverse events to patients and relatives]. Martín-Delgado, MC., Fernández-Maillo, M., Bañeres-Amella, J., et al.[2015]

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

Internet interventions can improve the well-being of informal caregivers for dementia patients, enhancing aspects like confidence, depression, and self-efficacy, especially when tailored to individual needs and including multiple components.

Despite showing potential benefits, the overall quality of evidence from the studies is low, indicating a need for more rigorous randomized controlled trials to better assess the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. Boots, LM., de Vugt, ME., van Knippenberg, RJ., et al.[2022]

A systematic review of 19 studies found that online dementia training programs significantly improve the preparedness and condition of both formal and informal caregivers, addressing the growing need for skilled dementia care as Alzheimer's disease rates rise.

Future research should focus on enhancing study designs by incorporating multiple time points, control groups, and personalized, interactive content to better evaluate the effectiveness of these online training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online dementia caregivers training programs: A systematic review. Pleasant, M., Molinari, V., Dobbs, D., et al.[2021]

References

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

Training family caregivers of patients with dementia. A structured workshop approach. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Improving adherence to guideline recommendations in dementia care through establishing a quality improvement collaborative of agents of change: an interrupted time series study. [2022]

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

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

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

Moving Evidence-Informed Assessment and Management of Behavioral and Psychological Symptoms of Dementia into the Real World: Training Family and Staff Caregivers in the DICE Approach. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Caregiver active participation in psychoeducational intervention improved caregiving skills and competency. [2019]

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

Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 20: patient or caregiver training, patient monitoring and adverse events reporting, and quality-assurance program. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

“Watchful? For sure!” – Health professionals as family carers and their roles in patient safety [2019]

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. Spain pubmed.ncbi.nlm.nih.gov

[Consensus conference on providing information of adverse events to patients and relatives]. [2015]

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

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]

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

A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. [2022]

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

Developing a novel Internet-based psychoeducational intervention for dementia caregivers. [2016]

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

Effectiveness of online dementia caregivers training programs: A systematic review. [2021]

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

Designing and developing a co-produced theoretical and evidence-based online support for family caregivers of people with dementia at the end of life. [2023]

15. Canada pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Implementing Web-Based Dementia Caregiver Education From the Clinician's Perspective: Qualitative Study. [2020]