WeCareAdvisor Study for Caregivers of People Living With Dementia

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Frontotemporal Dementia; Vascular Dementia; Dementia With Lewy Bodies; Caregiver Stress Syndrome; Caregiver Burnout
• Intervention / Treatment: Behavioral: Immediate treatment group with High-Intensity Prompts; Behavioral: Immediate treatment group with Low-Intensity Prompts; Behavioral: Waitlist Control after three months with High-Intensity Prompts; Behavioral: Waitlist Control after three months with Low-Intensity Prompts

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.

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate treatment group with High-Intensity Prompts; Caregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts.	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.
Experimental: Immediate treatment group with Low-Intensity Prompts; Caregivers will use the WeCareAdvisor tool for six months and receive email prompts only.	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.
Experimental: Waitlist Control after three months with high-Intensity prompts; After three months, caregivers will receive WeCareAdvisor and telephone and email prompts.	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.
Experimental: Waitlist Control after three months with Low-Intensity Prompts; After three months, caregivers will receive WeCareAdvisor and email prompts only.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Short-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity	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
Long-Term Change in Person Living with Dementia- Frequency of Behaviors by Severity	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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.
Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia	Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely)	1 months
Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia	Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely)	3 months
Short-Term Change in Person Living with Dementia- Frequency of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms.	1 months
Long-Term Change in Person Living with Dementia- Frequency of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms.	3 months
Short-Term Change in Person Living with Dementia- Severity of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms.	1 months
Long-Term Change in Person Living with Dementia- Severity of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms.	3 months
Short-Term Change in Person Living with Dementia- Number of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no).	1 months
Long-Term Change in Person Living with Dementia- Number of Behaviors	Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no).	3 months

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: Johns Hopkins University; National Institute on Aging (NIA); University of California, Davis
• Investigators: Principal Investigator: Laura N Gitlin, PhD, Drexel University; Principal Investigator: Helen C Kales, MD, University of California, Davis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): July 19, 2024
• Study Completion (Actual): July 19, 2024

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: dementia; caregiver; alzheimer's disease; memory loss
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Metabolic Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Stress, Psychological; Parkinsonian Disorders; Basal Ganglia Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Arteriosclerosis; Arterial Occlusive Diseases; Leukoencephalopathies; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Frontotemporal Lobar Degeneration; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Caregiver Burden; Alzheimer Disease; Dementia; Frontotemporal Dementia; Dementia, Vascular; Lewy Body Disease; Memory Disorders
• Other Study ID Numbers: 2007007999; 1R01AG061116-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be stored after 7 years following completion of study and reporting of main outcomes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No