WeCareAdvisor Study for Caregivers of People Living With Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2024-07-19

Brief Summary

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The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia. The trial will evaluate its efficacy to reduce caregiver distress, improve confidence managing behaviors, as well as reduce occurrences and severity of behavioral and psychological symptoms.

Visit https://wecareadvisorstudy.com/ for more information.

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Detailed Description

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Caregivers enrolled in the study will use the web-based WeCareAdvisor tool for either three or six months, depending upon group allocation (immediate treatment vs. 3-month waitlist). Caregivers will be interviewed at baseline, 1, 3 and 6 months by telephone to evaluate their health and wellbeing. Also, utilization data of the tool will be captured.

Conditions

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Dementia Caregiver Burnout Caregiver Stress Syndrome Alzheimer Disease Frontotemporal Dementia Vascular Dementia Dementia With Lewy Bodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Prospective randomized trial involving an immediate treatment group (Group A) and a 3-month waitlist control group (Group B). Also, groups will be randomized to different prompting conditions (email only, telephone and email) to remind participants to use the tool.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Single blind allocation. Study interviewers will be masked to group allocation. Other research personnel (investigator, project manager, interventionist), may become aware of group allocation. Caregivers will be asked not to disclose to interviewers the group to which they are assigned.

Study Groups

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Immediate treatment group with High-Intensity Prompts

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

Group Type EXPERIMENTAL

Immediate treatment group with High-Intensity Prompts

Intervention Type BEHAVIORAL

Caregivers in the immediate treatment group with high-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive telephone and email prompts to use the tool.

Immediate treatment group with Low-Intensity Prompts

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

Group Type EXPERIMENTAL

Immediate treatment group with Low-Intensity Prompts

Intervention Type BEHAVIORAL

Caregivers in the immediate treatment group with low-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive email prompts to use the tool.

Waitlist Control after three months with high-Intensity prompts

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

Group Type EXPERIMENTAL

Waitlist Control after three months with High-Intensity Prompts

Intervention Type BEHAVIORAL

After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive telephone and email prompts. Once the caregiver receives the WeCareAdvisor tool, they will receive a weekly automated email as well as a weekly telephone call from study staff to prompt them to use the tool.

Waitlist Control after three months with Low-Intensity Prompts

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

Group Type EXPERIMENTAL

Waitlist Control after three months with Low-Intensity Prompts

Intervention Type BEHAVIORAL

After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive email prompts.

Interventions

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Immediate treatment group with High-Intensity Prompts

Caregivers in the immediate treatment group with high-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive telephone and email prompts to use the tool.

Intervention Type BEHAVIORAL

Immediate treatment group with Low-Intensity Prompts

Caregivers in the immediate treatment group with low-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive email prompts to use the tool.

Intervention Type BEHAVIORAL

Waitlist Control after three months with High-Intensity Prompts

After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive telephone and email prompts. Once the caregiver receives the WeCareAdvisor tool, they will receive a weekly automated email as well as a weekly telephone call from study staff to prompt them to use the tool.

Intervention Type BEHAVIORAL

Waitlist Control after three months with Low-Intensity Prompts

After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive email prompts.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* self-identify as the primary caregiver to the person living with memory loss or dementia;
* has been a primary caregiver for at least 6 months;
* report managing \>1 behavioral symptom(s) in the past month;
* has an email account or smartphone (to receive daily tips and reminder messages);
* English speaking;
* has own smartphone, tablet, laptop, or desktop computer and access to Internet;
* If person living with dementia is on an anti-dementia or psychotropic medication, they must be on a stable dose for at least 60 days prior to enrollment.
* If caregiver is on an anti-depression or other psychotropic medication, they must be on a stable does for at least 60 days prior to enrollment
* Lives in the United States or US territory

Exclusion Criteria

* Caregiver currently involved in another clinical trial of psychosocial or educational interventions for dementia;
* Caregiver has a visual impairment that prohibits interaction with the tool, and/or have a hearing impairment sufficient to prohibit telephone communication;
* Caregiver reports person living with dementia is not responsive to his/her environment (e.g., unable to understand short commands or recognize a person coming in/out of the room);
* Caregiver reports person living with dementia is an active suicide risk
* Caregiver reports person living with dementia is likely to have an imminent placement in a long-term care facility (within 6 months).
* Either caregiver/person living with dementia has a terminal disease with life expectancy \< 6 months, is in active treatment for cancer, or has had more than 3 acute medical hospitalizations over the past year.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes