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Completed

NCT Number: NCT05012410

WeCareAdvisor Study for Caregivers of People 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.

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Caregiver Burden Caregiver Burnout Caregiver Stress Syndrome Central Nervous System Diseases Cerebrovascular Disorders Dementia With Lewy Bodies Dementia, Vascular Frontotemporal Dementia Frontotemporal Lobar Degeneration Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Memory Disorders Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Stress, Psychological Synucleinopathies TDP-43 Proteinopathies Tauopathies Vascular Dementia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

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 Low-Intensity Prompts

Behavioral

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

Primary outcomes

  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 of Behaviors by Severity

    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 of Behaviors by Severity

    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 outcomes

  1. 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)

  2. 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)

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

    Time frame: 1 months

    Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely)

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

    Time frame: 3 months

    Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely)

  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 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.

  7. 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.

  8. 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).

  9. 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).

  10. 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.

  11. Short-Term Change in Person Living with Dementia- Frequency of Behaviors

    Time frame: 1 months

    Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms.

  12. Long-Term Change in Person Living with Dementia- Frequency 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) of behavioral symptoms.

  13. Short-Term Change in Person Living with Dementia- Severity of Behaviors

    Time frame: 1 months

    Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms.

  14. Long-Term Change in Person Living with Dementia- Severity of Behaviors

    Time frame: 3 months

    Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms.

  15. Short-Term Change in Person Living with Dementia- Number of Behaviors

    Time frame: 1 months

    Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no).

  16. Long-Term Change in Person Living with Dementia- Number of Behaviors

    Time frame: 3 months

    Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no).

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2021
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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