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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG061116-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| National Institute on Aging (NIA) | NIH |
| Johns Hopkins University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment group with High-Intensity Prompts | Experimental | Caregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts. |
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| Immediate treatment group with Low-Intensity Prompts | Experimental | Caregivers will use the WeCareAdvisor tool for six months and receive email prompts only. |
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| Waitlist Control after three months with high-Intensity prompts | Experimental | After three months, caregivers will receive WeCareAdvisor and telephone and email prompts. |
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| Waitlist Control after three months with Low-Intensity Prompts | Experimental | After three months, caregivers will receive WeCareAdvisor and email prompts only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Short-Term Change in Person with Dementia- Level of Functioning | 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) | 1 months |
| Long-Term Change in Person with Dementia- Level of Functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura N Gitlin, PhD | Drexel University | Principal Investigator |
| Helen C Kales, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33786370 | Background | 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. | |
| 28800895 | Result | 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. |
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Data will be stored after 7 years following completion of study and reporting of main outcomes.
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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.
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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.
| 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. |
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| 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. |
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| 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. |
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| 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 |
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 months |
| Short-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia | Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely) | 1 months |
| Long-Term Change in Caregiver Upset with Level of Functioning of Person with Dementia | Caregiver Assessment of Function (CAFU), a psychometrically sound scale measuring level of upset with ADLs/ IADLs dependence (0=Not at all to 4=Extremely) | 3 months |
| Change in Person with Dementia's Medications | 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 months |
| Short Term Change in Caregiver Wellbeing | 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. | 1 Month |
| Long Term Change in Caregiver Wellbeing | 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. | 3 Months |
| Short Term Change in Caregiver- Negative Communications | 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). | 1 Month |
| Long Term Change in Caregiver- Negative Communications | 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). | 3 Month |
| Utilization of tool use | 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. | Through study completion, up to 6 months. |
| Short-Term Change in Person Living with Dementia- Frequency of Behaviors | Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms. | 1 months |
| Long-Term Change in Person Living with Dementia- Frequency of Behaviors | Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring frequency (0=none to 4=very frequently) of behavioral symptoms. | 3 months |
| Short-Term Change in Person Living with Dementia- Severity of Behaviors | Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms. | 1 months |
| Long-Term Change in Person Living with Dementia- Severity of Behaviors | Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring severity (0=none to 3=marked) of behavioral symptoms. | 3 months |
| Short-Term Change in Person Living with Dementia- Number of Behaviors | Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no). | 1 months |
| Long-Term Change in Person Living with Dementia- Number of Behaviors | Neuropsychiatric Inventory- Clinician version (NPI-C) is a well-validated questionnaire measuring the number of behavioral symptoms of dementia endorsed (1=yes,0=no). | 3 months |
| 29747583 | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| D000544 | Alzheimer Disease |
| D057180 | Frontotemporal Dementia |
| D015140 | Dementia, Vascular |
| D020961 | Lewy Body Disease |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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