WeCareAdvisor Study for Caregivers of People Living With Dementia

Drexel University

Status: Completed

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

Treatments: Behavioral: Waitlist Control after three months with High-Intensity Prompts; Behavioral: Immediate treatment group with High-Intensity Prompts; Behavioral: Waitlist Control after three months with Low-Intensity Prompts; Behavioral: Immediate treatment group with Low-Intensity Prompts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05012410

2007007999

1R01AG061116-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 262 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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262 participants in 4 patient groups

Immediate treatment group with High-Intensity Prompts

Experimental group

Description:

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

Treatment:

Behavioral: Immediate treatment group with High-Intensity Prompts

Immediate treatment group with Low-Intensity Prompts

Experimental group

Description:

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

Treatment:

Behavioral: Immediate treatment group with Low-Intensity Prompts

Waitlist Control after three months with high-Intensity prompts

Experimental group

Description:

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

Treatment:

Behavioral: Waitlist Control after three months with High-Intensity Prompts

Waitlist Control after three months with Low-Intensity Prompts

Experimental group

Description:

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

Treatment:

Behavioral: Waitlist Control after three months with Low-Intensity Prompts