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WeCareAdvisor Study for Caregivers of People Living With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05012410
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : January 5, 2022
Sponsor:
Collaborators:
University of California, Davis
National Institute on Aging (NIA)
Johns Hopkins University
Information provided by (Responsible Party):
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.


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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : December 7, 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : October 2025


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.




Primary Outcome Measures :
  1. Short-term Change in Caregiver Distress with Behaviors [ Time Frame: 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)

  2. Long-term Change in Caregiver Distress with Behaviors (3-Months) [ Time Frame: 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. Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia [ Time Frame: 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)

  4. Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia [ Time Frame: 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))

  5. Short-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors [ Time Frame: 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)

  6. Long-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors [ Time Frame: 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 :
  1. Short-Term Change in Person with Dementia- Level of Physical Dependence [ Time Frame: 1 months ]
    Caregivers will identify the staging of functionality that the person of living with dementia has, using the Functional Assessment Staging (FAST) scale.

  2. Long-Term Term Change in Person with Dementia- Level of Physical Dependence [ Time Frame: 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

  3. Short-Term Change in Person with Dementia- Level of Functioning [ Time Frame: 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)

  4. Long-Term Change in Person with Dementia- Level of Functioning [ Time Frame: 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)

  5. Change in Person with Dementia's Medications [ Time Frame: 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).

  6. Short-term Change in Caregiver's Depressive Symptoms [ Time Frame: 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.

  7. Long-term Change in Caregiver's Depressive Symptoms [ Time Frame: 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

  8. Short Term Change in Caregiver Wellbeing [ Time Frame: 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.

  9. Long Term Change in Caregiver Wellbeing [ Time Frame: 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.

  10. Short Term Change in Caregiver- Negative Communications [ Time Frame: 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).

  11. Long Term Change in Caregiver- Negative Communications [ Time Frame: 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).

  12. Utilization of tool use [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05012410


Contacts
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Contact: WeCareAdvisor Study Team 267-359-1111 wecare@drexel.edu

Locations
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United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: WeCareAdvisor Study Team       wecare@drexel.edu   
Sponsors and Collaborators
Drexel University
University of California, Davis
National Institute on Aging (NIA)
Johns Hopkins University
Investigators
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Principal Investigator: Laura N Gitlin, PhD Drexel University
Principal Investigator: Helen C Kales, MD University of California, Davis
Publications of Results:
Other Publications:
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT05012410    
Other Study ID Numbers: 2007007999
1R01AG061116-01 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be stored after 7 years following completion of study and reporting of main outcomes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Drexel University:
dementia
caregiver
alzheimer's disease
memory loss
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Lewy Body Disease
Dementia, Vascular
Caregiver Burden
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Stress, Psychological
Behavioral Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders