WeCareAdvisor Study for Caregivers of People Living With Dementia

Sponsor

Drexel University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05012410

Collaborator

University of California, Davis (Other), National Institute on Aging (NIA) (NIH), Johns Hopkins University (Other)

326

Enrollment

Location

Arms

45.8

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Caregiver Burnout Caregiver Stress Syndrome Alzheimer Disease Frontotemporal Dementia Vascular Dementia Dementia With Lewy Bodies	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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

326 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 7, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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 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 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 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)
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)

Secondary Outcome Measures

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
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)
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

self-identify as the primary caregiver to the person diagnosed with 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 3 or more acute medical hospitalizations over the past year.