WeCareAdvisor Study for Caregivers of People Living With Dementia

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05012410
• Lead Sponsor: Drexel University

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.

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Study Start: 2021-12-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-04-30
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 262

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia	1 month	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)
Long-term Change in Caregiver Distress with Behaviors (3-Months)	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)
Short-term Change in Caregiver Distress with Behaviors	1 Month	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)
Long-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors	3 Months	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)
Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia	3 months	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))
Short-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors	1 Month	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)

Secondary Outcome Measures

Name	Time	Method
Short-Term Change in Person with Dementia- Level of Functioning	1 months	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)
Long-Term Change in Person with Dementia- Level of Functioning	3 months	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)
Short-Term Change in Person with Dementia- Level of Physical Dependence	1 months	Caregivers will identify the staging of functionality that the person of living with dementia has, using the Functional Assessment Staging (FAST) scale.
Long-Term Term Change in Person with Dementia- Level of Physical Dependence	3 months	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
Change in Person with Dementia's Medications	6 months	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).
Short-term Change in Caregiver's Depressive Symptoms	1 month	Caregiver depression will be measured using the Patient Health Questionnaire (PHQ-8), scoring from 0-27, with higher scores indicating higher levels of depression.
Long-term Change in Caregiver's Depressive Symptoms	3 months	Caregiver depression will be measured using the Patient Health Questionnaire (PHQ-8), scoring from 0-27, with higher scores indicating higher levels of depression
Short Term Change in Caregiver Wellbeing	1 Month	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.
Short Term Change in Caregiver- Negative Communications	1 Month	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).
Long Term Change in Caregiver- Negative Communications	3 Month	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).
Utilization of tool use	Through study completion, up to 6 months.	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.
Long Term Change in Caregiver Wellbeing	3 Months	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.

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States