Clinical trial NCT05012410: WeCareAdvisor Study for Caregivers of People Living With Dementia
Official title: Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons Living With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Caregiver Burnout
Caregiver Stress Syndrome
Alzheimer Disease
Frontotemporal Dementia
Vascular Dementia
Dementia With Lewy Bodies
Keywords: dementia
caregiver
alzheimer's disease
memory loss
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: National Institute on Aging (NIA)
name: Johns Hopkins University
First posted: 2021-08-19
Enrollment: 262
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short-term Change in Caregiver Distress with Behaviors
timeFrame: 1 Month
measure: Long-term Change in Caregiver Distress with Behaviors (3-Months)
timeFrame: 3 months
measure: Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
timeFrame: 1 month
measure: Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
timeFrame: 3 months
measure: Short-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors
timeFrame: 1 Month
measure: Long-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors
timeFrame: 3 Months
Secondary outcomes:
measure: Short-Term Change in Person with Dementia- Level of Physical Dependence
timeFrame: 1 months
measure: Long-Term Term Change in Person with Dementia- Level of Physical Dependence
timeFrame: 3 months
measure: Short-Term Change in Person with Dementia- Level of Functioning
timeFrame: 1 months
measure: Long-Term Change in Person with Dementia- Level of Functioning
timeFrame: 3 months
measure: Change in Person with Dementia's Medications
timeFrame: 6 months
measure: Short-term Change in Caregiver's Depressive Symptoms
timeFrame: 1 month
measure: Long-term Change in Caregiver's Depressive Symptoms
timeFrame: 3 months
measure: Short Term Change in Caregiver Wellbeing
timeFrame: 1 Month
measure: Long Term Change in Caregiver Wellbeing
timeFrame: 3 Months
measure: Short Term Change in Caregiver- Negative Communications
timeFrame: 1 Month
measure: Long Term Change in Caregiver- Negative Communications
timeFrame: 3 Month
measure: Utilization of tool use
timeFrame: Through study completion, up to 6 months.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Laura N Gitlin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Helen C Kales, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gitlin LN, Bouranis N, Kern V, Koeuth S, Marx KA, McClure LA, Lyketsos CG, Kales HC. WeCareAdvisor, an Online Platform to Help Family Caregivers Manage Dementia-Related Behavioral Symptoms: an Efficacy Trial in the Time of COVID-19. J Technol Behav Sci. 2022;7(1):33-44. doi: 10.1007/s41347-021-00204-8. Epub 2021 Mar 25.
citation: Gitlin LN, Kales HC, Marx K, Stanislawski B, Lyketsos C. A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor. Contemp Clin Trials. 2017 Nov;62:27-36. doi: 10.1016/j.cct.2017.08.001. Epub 2017 Aug 9.
citation: Kales HC, Gitlin LN, Stanislawski B, Myra Kim H, Marx K, Turnwald M, Chiang C, Lyketsos CG. Effect of the WeCareAdvisor on family caregiver outcomes in dementia: a pilot randomized controlled trial. BMC Geriatr. 2018 May 10;18(1):113. doi: 10.1186/s12877-018-0801-8.