WeCareAdvisor Study for Caregivers of People Living With Dementia

Alzheimer Disease Clinical Trial

Official title:

Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons Living With Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05012410
• Other study ID #: 2007007999
• Secondary ID: 1R01AG061116-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 262
• Est. completion date: October 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Caregiver Burden
• Caregiver Burnout
• Caregiver Stress Syndrome
• Dementia
• Dementia With Lewy Bodies
• Dementia, Vascular
• Frontotemporal Dementia
• Lewy Body Disease
• Pick Disease of the Brain
• Vascular Dementia

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Drexel University	Johns Hopkins University, National Institute on Aging (NIA), University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Ep — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term Change in Caregiver Distress with Behaviors	For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)	1 Month
Primary	Long-term Change in Caregiver Distress with Behaviors (3-Months)	For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version (NPI-C), caregivers rate level of distress with behavior (0=not distressing to 5=extremely upset)	3 months
Primary	Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia	Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 = low confidence - 10= high confidence)	1 month
Primary	Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia	Caregivers will rate their level of confidence in dementia signs and symptom management using the 25-item Caregiver Confidence in Medical Sign/Symptom Management scale. For each of 13 domains of behavioral symptoms endorsed on the Neuropsychiatric Inventory-Clinician version, caregivers rate confidence managing behaviors (0 (low-confidence - 10- high-confidence))	3 months
Primary	Short-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors	Neuropsychiatric Inventory-Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)	1 Month
Primary	Long-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) and severity (0=none to 3=marked)	3 Months
Secondary	Short-Term Change in Person with Dementia- Level of Physical Dependence	Caregivers will identify the staging of functionality that the person of living with dementia has, using the Functional Assessment Staging (FAST) scale.	1 months
Secondary	Long-Term Term Change in Person with Dementia- Level of Physical Dependence	Caregivers will identify the staging of functionality that the person of living with dementia has, using the Functional Assessment Staging (FAST) scale from 0= normal aging to 7= severe dementia	3 months
Secondary	Short-Term Change in Person with Dementia- Level of Functioning	Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring # of ADLs/ IADLs needing assistance, and dependence level (1=total dependence to 7=total independence)	1 months
Secondary	Long-Term Change in Person with Dementia- Level of Functioning	Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring # of ADLs/ IADLs needing assistance, and dependence level (1=total dependence to 7=total independence)	3 months
Secondary	Change in Person with Dementia's Medications	Caregivers are asked to retrieve (e.g., Brown bag review) prescription and non-prescription medications of person living with dementia and relay name, frequency, and dosage for each medication to interviewer. The investigators will track information on changes in psychotropic medication use for persons living with dementia (intensifications, reductions, additions/deletions, or 'prn' or as needed use).	6 months
Secondary	Short-term Change in Caregiver's Depressive Symptoms	Caregiver depression will be measured using the Patient Health Questionnaire (PHQ-8), scoring from 0-27, with higher scores indicating higher levels of depression.	1 month
Secondary	Long-term Change in Caregiver's Depressive Symptoms	Caregiver depression will be measured using the Patient Health Questionnaire (PHQ-8), scoring from 0-27, with higher scores indicating higher levels of depression	3 months
Secondary	Short Term Change in Caregiver Wellbeing	The investigators will use the 13-item Perceived Change for Better Index which assesses caregiver perceived change (1= gotten worse to 5= improved a lot) in affective wellbeing, somatic, ability to manage daily care. It is sensitive to change and has strong psychometric properties.	1 Month
Secondary	Long Term Change in Caregiver Wellbeing	The investigators will use the 13-item Perceived Change for Better Index which assesses caregiver perceived change (0=gotten worse to 5=improved a lot) in affective wellbeing, somatic, ability to manage daily care. It is sensitive to change and has strong psychometric properties.	3 Months
Secondary	Short Term Change in Caregiver- Negative Communications	The investigators will use six items from various scales that assess frequency of use (1=Never to 5=Always) of negative communications by caregivers with persons with dementia (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming).	1 Month
Secondary	Long Term Change in Caregiver- Negative Communications	The investigators will use six items from various scales that assess frequency of use (1=Never to 5=Always) of negative communications by caregivers with persons with dementia (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming).	3 Month
Secondary	Utilization of tool use	Dashboard data indicating number of times using tool, number of times using each section of the tool, amount of time spent and for each section of the tool, number of DICE sessions started and completed.	Through study completion, up to 6 months.