WeCareAdvisor for Caregiver Support in Dementia

Overseen By WeCareAdvisor Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Visual impairment, Hearing impairment, Terminal disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online tool called WeCareAdvisor, designed to help caregivers manage difficult behaviors in people with dementia. The trial aims to determine if the tool can reduce caregiver stress and improve confidence in handling these behaviors. Participants will either begin using the tool immediately or after a three-month wait, with varying levels of support such as phone or email prompts. This trial suits primary caregivers who have been in this role for at least six months and are managing behavioral symptoms in someone with dementia. For more details, visit the study's website. As an unphased trial, it offers caregivers the chance to explore innovative support methods that could enhance their caregiving experience.

Do I need to stop my current medications to join the trial?

No, you don't need to stop your current medications. However, if you or the person you care for are on anti-dementia, anti-depression, or other psychotropic medications, you must have been on a stable dose for at least 60 days before joining the trial.

What prior data suggests that the WeCareAdvisor tool is safe for caregivers?

Research shows that the WeCareAdvisor tool is safe for use. This tool assists caregivers in managing behavior and mood issues in people with dementia. As an online platform, it lacks the medical side effects associated with medications.

Previous studies have shown positive results. Caregivers using the WeCareAdvisor tool reported feeling less stressed and upset. These studies found no problems or safety issues. The tool's online nature makes it easy to use and free from harm or discomfort.

So far, research supports that WeCareAdvisor is safe and helpful for caregivers. For those considering joining a trial, this tool appears to be a low-risk choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WeCareAdvisor tool for caregiver support in dementia because it offers a personalized approach to managing caregiver stress and burnout. Unlike traditional support options that may include in-person support groups or counseling, WeCareAdvisor is a digital platform that caregivers can access anytime, providing convenience and flexibility. The tool delivers tailored prompts and guidance via email or telephone, helping caregivers address their specific challenges in real-time. Additionally, the use of high- and low-intensity prompts allows for a customizable experience, potentially enhancing the effectiveness of support based on individual needs.

What evidence suggests that the WeCareAdvisor tool is effective for caregiver support in dementia?

Research shows that the WeCareAdvisor tool benefits caregivers of people with dementia. In this trial, researchers will divide participants into groups to assess the tool's effectiveness. Some caregivers will use the WeCareAdvisor tool for six months with high-intensity prompts, while others will receive low-intensity prompts. Additionally, waitlist control groups will start using the tool after three months, with either high-intensity or low-intensity prompts. One study found that caregivers who used the tool felt significantly less stressed, with stress levels dropping by about 6 points on a distress scale after just one month. Other studies have found that the tool also reduces the frequency and severity of dementia-related behaviors. As a result, caregivers felt less overwhelmed and more confident in managing challenging behaviors. Overall, evidence suggests that the WeCareAdvisor can significantly improve caregivers' daily lives. ^{1 2 3 6 7}

Who Is on the Research Team?

Laura N Gitlin, PhD

Principal Investigator

Drexel University

Helen C Kales, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for primary caregivers who have been caring for someone with dementia for at least 6 months, can use a smartphone or computer with internet, and speak English. They must not be planning to move the person into long-term care soon, be in another similar study, or have severe visual/hearing impairments.

Inclusion Criteria

You have experienced more than one behavioral symptom in the past month.

I have been on a stable dose of my mental health medication for at least 60 days.

Lives in the United States or US territory

Exclusion Criteria

The person with dementia is at risk of attempting suicide, as reported by their caregiver.

You are currently helping with a different study about helping people with memory problems.

The person I care for with dementia does not respond to their surroundings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers use the WeCareAdvisor tool for either three or six months, depending on group allocation, with varying intensity of prompts

3-6 months

Interviews at baseline, 1, 3, and 6 months by telephone

Follow-up

Participants are monitored for long-term changes in caregiver distress, confidence, and wellbeing, as well as changes in the person with dementia's symptoms and medication use

3 months

What Are the Treatments Tested in This Trial?

Interventions

• WeCareAdvisor Study

Trial Overview The WeCareAdvisor online tool is being tested to see if it helps caregivers manage dementia-related behaviors better. Caregivers are split into groups: some get immediate prompts from the tool; others wait three months before starting. The intensity of these prompts varies between high and low.

How Is the Trial Designed?

Group I: Waitlist Control after three months with high-Intensity prompts Experimental Treatment 1 Intervention

After three months, caregivers will receive WeCareAdvisor and telephone and email prompts.

Group II: Waitlist Control after three months with Low-Intensity Prompts Experimental Treatment 1 Intervention

After three months, caregivers will receive WeCareAdvisor and email prompts only.

Group III: Immediate treatment group with Low-Intensity Prompts Experimental Treatment 1 Intervention

Caregivers will use the WeCareAdvisor tool for six months and receive email prompts only.

Group IV: Immediate treatment group with High-Intensity Prompts Experimental Treatment 1 Intervention

Caregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5432421/

WeCareAdvisor™: The development of a caregiver ... The randomized controlled trial of WeCareAdvisor™ will test whether the tool improves outcomes including caregiver upset and burden and frequency and severity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7994055/

WeCareAdvisor, an Online Platform to Help Family ... The enhanced design features will yield new knowledge concerning tool efficacy on key outcomes of importance to families, and whether ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05012410

WeCareAdvisor Study for Caregivers of People Living With ... The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia.

4. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-018-0801-8

Effect of the WeCareAdvisor™ on family caregiver outcomes ... After their one-month of tool use (T1), WCA caregivers showed significant within group improvement in caregiver distress (− 6.08 ± 6.31 points, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714417303385

A randomized trial of a web-based platform to help families ... During treatment phase, participants receive 3 weekly check-in calls to encourage tool use and troubleshoot. Key outcomes include number of times using ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1016/j.jalz.2017.07.030

[F1–05–04]: WECAREADVISOR™: A RANDOMIZED ... Preliminary results from the trial are encouraging with significant change in caregiver outcomes with tool use for one month. The lessons ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29747583/

Effect of the WeCareAdvisor™ on family caregiver outcomes ... After their one-month of tool use (T1), WCA caregivers showed significant within group improvement in caregiver distress (- 6.08 ± 6.31 points, ...