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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program called Compass for Care, designed to assist those caring for a loved one with Alzheimer's or similar dementia. It supports caregivers by providing guidance on essential self-care activities, such as taking breaks, finding information, and seeking emotional support. The trial compares two versions of the program: one focuses on caregiver well-being, and the other on safety practices. This trial may suit individuals who provide at least 8 hours of unpaid care each week for someone with dementia and experience significant stress or burden. As an unphased trial, it offers caregivers the chance to explore innovative support tools tailored to their unique needs.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Compass for Care program is generally safe for users. Studies on similar programs indicate they improve well-being without causing harm. Specifically, past research has shown that these programs enhance communication and quality of life for dementia patients and their caregivers. They also ease caregiver burden and boost empathy.

The safety aspect emphasizes practical actions like home safety and first aid. No evidence suggests negative effects from using these types of digital programs. Overall, these programs aim to support caregivers without compromising their health or safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Compass for Care interventions because they focus on enhancing the well-being and safety of dementia caregivers, a group often overlooked in traditional treatment plans. Unlike typical caregiver support that might center on therapy or support groups, Compass for Care offers a structured set of 12 weekly modules delivered digitally, making it highly accessible. The well-being intervention emphasizes crucial self-care practices, helping caregivers recharge, find information, recognize their strengths and limits, explore outside help, and seek emotional support. Meanwhile, the safety intervention focuses on practical safety behaviors like weather safety and first aid, which are paramount for creating a secure environment for both the caregiver and their loved one. By addressing both emotional and practical needs, Compass for Care represents a comprehensive approach that could significantly improve the quality of life for caregivers.

What evidence suggests that the Compass for Care program is effective for improving caregiver well-being?

Research has shown that the Compass for Care program can enhance the well-being of those caring for someone with dementia. In this trial, participants will join one of two interventions: the Compass for Care well-being intervention or the Compass for Care safety intervention. Studies have found that the well-being intervention, which promotes self-care, reduces depression and emotional stress among caregivers. It uses an online platform to guide caregivers through activities like taking breaks, seeking support, and finding helpful information, which are crucial for mental health. Early results suggest that addressing caregivers' individual needs in this program significantly boosts their well-being. Evidence indicates that such programs can offer long-term benefits, including reduced depression. ^{1 2 3 4 6}

Who Is on the Research Team?

Kerry E Evers, PhD

Principal Investigator

Pro-Change Behavior Systems

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06249139

Study Details | NCT06249139 | Compass for Care: A ... 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 ...

2. aging.jmir.org aging.jmir.org/2024/1/e47565/

Efficacy of COMPAs, an App Designed to Support ... Conclusions: COMPAs intervention improved well-being in persons living with dementia and their caregivers by developing person-centered ...

3. withpower.com withpower.com/trial/phase-dementia-10-2023-0f4a3

Compass for Care for Dementia Caregivers ... In a pilot study involving 47 participants aged 60 and over with dementia, person-centered care (PCC) significantly improved behavioral and neuropsychiatric ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11258517/

Efficacy of COMPAs, an App Designed to Support ... COMPAs intervention improved well-being in persons living with dementia and their caregivers by developing person-centered communication within the dyad.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5024377/

Safety and Health Support for Home Care Workers Objectives. To determine the effectiveness of the COMmunity of Practice And Safety Support (COMPASS) Total Worker Health intervention for home care workers.

6. stacks.cdc.gov stacks.cdc.gov/view/cdc/215989

Safety and Health Support for Home Care Workers Objectives. To determine the effectiveness of the COMmunity of Practice And Safety Support (COMPASS) Total Worker Health intervention for home care workers.