Compass for Care for Dementia Caregivers

(Compass4Care Trial)

Overseen By Deborah F Van Marter, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pro-Change Behavior Systems

Disqualifiers: Suicidal ideation

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

305 Participants Needed

Trial Summary

What is the purpose of this trial?

In the US, the over 11 million Americans currently providing unpaid care to a family member, relative, or friend with Alzheimer's disease or a related dementia (ADRD) are over 6 times more likely than the general population to suffer from depression (33.9% vs. 5%), and nearly 60% rate their emotional distress as high or very high. The purpose of this Phase II research is to continue the successful work of the pilot development and testing by conducting a rigorous scientific study of the effects of Compass for Care, a digital program that customizes behavior change guidance for using five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Compass for Care for dementia caregivers?

The research highlights the importance of person-centered care and positive psychology in improving outcomes for dementia caregivers. Studies show that focusing on positive aspects, like hope and resilience, can enhance caregivers' well-being, suggesting that treatments like Compass for Care, which may incorporate these elements, could be beneficial. ^{1 2 3 4 5}

How is the Compass for Care treatment different from other dementia caregiver treatments?

Compass for Care is unique because it focuses on providing tailored support and resources specifically for dementia caregivers, potentially through a combination of online and in-person components, which is not commonly found in other treatments. ^{6 7 8 9 10}

Research Team

Kerry E Evers, PhD

Principal Investigator

Pro-Change Behavior Systems

Eligibility Criteria

This trial is for caregivers of individuals with Alzheimer's disease or related dementias (ADRD) who are experiencing high levels of emotional distress. It aims to help them manage their well-being through a digital program called Compass for Care.

Inclusion Criteria

Expecting to provide care to their family member or friend for at least three more months, or don't know how much longer they will be providing care

Have been providing care for at least 3 months

Score of 3 or higher on the Zarit burden item (Overall, how burdened do you feel in caring for your relative) OR a score of 2 on this item and a score of 2+ on the PHQ-2 assessment (i.e., Little interest or pleasure in doing things; Feeling down, depressed, or hopeless)

Exclusion Criteria

Indicating suicidal ideation based upon the PHQ-9 suicidality ideation item (i.e., Thoughts that you would be better off dead, or of hurting yourself)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Online screening survey

Treatment

Participants receive the Compass for Care intervention or a safety intervention, delivered in 12 weekly modules with daily messages via text or email

12 weeks

Follow-up

Participants are monitored for outcomes such as caregiver burden, depression, and well-being at 3, 6, and 9 months

9 months

Online assessments at 3, 6, and 9 months

Treatment Details

Interventions

• Compass for Care

Trial Overview The study tests two versions of the Compass for Care mobile app, one focusing on safety and the other on overall well-being. The goal is to see if these apps can reduce stress and improve mental health among ADRD caregivers.

Participant Groups

Group I: Compass for Care (Well-being intervention) Experimental Treatment 1 Intervention

Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email. The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.

Group II: Compass for Care (Safety intervention) Active Control 1 Intervention

Participants receive 12 weekly modules and tailored messages delivered via text message or email. The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)

Who Is Running the Clinical Trial?

Pro-Change Behavior Systems

Lead Sponsor

Trials

17

Recruited

14,800+

Findings from Research

Person-centered outcome measures (PCOMs) can enhance shared decision-making in dementia care by helping to understand individual needs, set care priorities, and evaluate treatment decisions, based on a review of 10 studies involving 1064 participants.

While PCOMs show potential for improving communication and care outcomes, the evidence for their effectiveness in enhancing physical function and daily activities remains weak, indicating a need for further research and training for family caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do person-centered outcome measures enable shared decision-making for people with dementia and family carers?-A systematic review. Aworinde, J., Ellis-Smith, C., Gillam, J., et al.[2023]

The COM-IC project aims to develop and implement core outcome measures for evaluating dementia care in Australia, using a participatory approach that involves stakeholders such as people living with dementia and caregivers.

A 6-month feasibility study will test the practicality and acceptability of these measures within aged care organizations, ensuring that the outcomes are relevant and useful for improving dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the success of programmes of care for people living with dementia: a protocol for consensus building with consumers to develop a set of Core Outcome Measures for Improving Care (COM-IC). Comans, T., Nguyen, K., Gray, L., et al.[2023]

In a pilot study involving 47 participants aged 60 and over with dementia, person-centered care (PCC) significantly improved behavioral and neuropsychiatric symptoms and care quality compared to usual care after 4-5 days.

Sustained improvements in care quality were observed for patients with longer hospital stays, indicating that PCC can be beneficial for enhancing the overall care experience for individuals with dementia in acute hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. Chenoweth, L., Williams, A., Fry, M., 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 survey of 161 dementia care mappers from the US and UK revealed significant differences in the usage and satisfaction levels of dementia care mapping (DCM) between the two countries, indicating a need for tailored approaches in implementation.

Despite these differences, both groups reported positive impacts of DCM on their attitudes towards dementia care, although time constraints were a common challenge faced by mappers in both regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-cultural comparison of the perceptions and experiences of dementia care mapping "mappers" in the United States and the United Kingdom. Douglass, C., Keddie, A., Brooker, D., et al.[2016]

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]

The 'Partner in Balance' (PiB) program, which combines face-to-face coaching with online modules, was well-received by both caregivers and coaches, with a participation rate of 51.9% among eligible caregivers, indicating its potential effectiveness in supporting early-stage dementia caregivers.

Despite overall satisfaction, challenges such as recruitment barriers and the need for tailored content for specific subgroups, like younger caregivers, were identified, suggesting that further adaptation and awareness of blended care programs are necessary for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial. Boots, LM., de Vugt, ME., Smeets, CM., et al.[2022]

References

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

How do person-centered outcome measures enable shared decision-making for people with dementia and family carers?-A systematic review. [2023]

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

Measuring the success of programmes of care for people living with dementia: a protocol for consensus building with consumers to develop a set of Core Outcome Measures for Improving Care (COM-IC). [2023]

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

Measuring hope and resilience in carers of people living with dementia: The positive psychology outcome measure for carers (PPOM-C). [2023]

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

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. [2022]

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

Short-Term Effects of a Gain-Focused Reappraisal Intervention for Dementia Caregivers: A Double-Blind Cluster-Randomized Controlled Trial. [2019]

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

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

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

Dementia care in eight European countries: developing a mapping system to explore systems. [2018]

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

Cross-cultural comparison of the perceptions and experiences of dementia care mapping "mappers" in the United States and the United Kingdom. [2016]

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

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

10. Canada pubmed.ncbi.nlm.nih.gov

Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial. [2022]