WeCareAdvisor Study for Caregivers of People Living With Dementia

NCT05012410 | Completed

• 2 other identifiers: 20070079991R01AG061116-01
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (16)

• Short-Term Change in Person with Dementia- Level of Functioning

  1 months

• Long-Term Change in Person with Dementia- Level of Functioning

  3 months

• Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia

  1 months

• Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia

  3 months

• Change in Person with Dementia's Medications

  6 months

Study Arms (4)

Immediate treatment group with High-Intensity Prompts

EXPERIMENTAL

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

Behavioral: Immediate treatment group with High-Intensity Prompts

Immediate treatment group with Low-Intensity Prompts

EXPERIMENTAL

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

Behavioral: Immediate treatment group with Low-Intensity Prompts

Waitlist Control after three months with high-Intensity prompts

EXPERIMENTAL

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

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

Waitlist Control after three months with Low-Intensity Prompts

EXPERIMENTAL

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

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

Interventions

Immediate treatment group with High-Intensity Prompts 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 High-Intensity Prompts

Immediate treatment group with Low-Intensity Prompts 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.

Immediate treatment group with Low-Intensity Prompts

Waitlist Control after three months with High-Intensity Prompts 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 high-Intensity prompts

Waitlist Control after three months with Low-Intensity Prompts BEHAVIORAL

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

Waitlist Control after three months with Low-Intensity Prompts

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead
• University of California, Davis: collaborator
• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Related 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.

  PMID: 33786370 BACKGROUND

• 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.

  PMID: 28800895 RESULT

• 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.

  PMID: 29747583 RESULT

MeSH Terms

Conditions

Dementia; Caregiver Burden; Alzheimer Disease; Frontotemporal Dementia; Dementia, Vascular; Lewy Body Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Tauopathies; Neurodegenerative Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura N Gitlin, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

• Helen C Kales, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 19, 2021
• Study Start: December 13, 2021
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)