Back to resultsWeCareAdvisor Study for Caregivers of People Living With Dementia
Primary Purpose
Dementia, Caregiver Burnout, Caregiver Stress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate treatment group with High-Intensity Prompts
Immediate treatment group with Low-Intensity Prompts
Waitlist Control after three months with High-Intensity Prompts
Waitlist Control after three months with Low-Intensity Prompts
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring dementia, caregiver, alzheimer's disease, memory loss
Eligibility 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.
Sites / Locations
- Drexel UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Immediate treatment group with High-Intensity Prompts
Immediate treatment group with Low-Intensity Prompts
Waitlist Control after three months with high-Intensity prompts
Waitlist Control after three months with Low-Intensity Prompts
Arm Description
Caregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts.
Caregivers will use the WeCareAdvisor tool for six months and receive email prompts only.
After three months, caregivers will receive WeCareAdvisor and telephone and email prompts.
After three months, caregivers will receive WeCareAdvisor and email prompts only.
Outcomes
Primary Outcome Measures
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)
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)
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)
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))
Short-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT05012410
First Posted
August 6, 2021
Last Updated
January 4, 2022
Sponsor
Drexel University
Collaborators
University of California, Davis, National Institute on Aging (NIA), Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05012410
Brief Title
WeCareAdvisor Study for Caregivers of People Living With Dementia
Official Title
Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons Living With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
University of California, Davis, National Institute on Aging (NIA), Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Caregiver Burnout, Caregiver Stress Syndrome, Alzheimer Disease, Frontotemporal Dementia, Vascular Dementia, Dementia With Lewy Bodies
Keywords
dementia, caregiver, alzheimer's disease, memory loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
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.
Allocation
Randomized
Enrollment
326 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate treatment group with High-Intensity Prompts
Arm Type
Experimental
Arm Description
Caregivers will use the WeCareAdvisor tool for six months and receive telephone and email prompts.
Arm Title
Immediate treatment group with Low-Intensity Prompts
Arm Type
Experimental
Arm Description
Caregivers will use the WeCareAdvisor tool for six months and receive email prompts only.
Arm Title
Waitlist Control after three months with high-Intensity prompts
Arm Type
Experimental
Arm Description
After three months, caregivers will receive WeCareAdvisor and telephone and email prompts.
Arm Title
Waitlist Control after three months with Low-Intensity Prompts
Arm Type
Experimental
Arm Description
After three months, caregivers will receive WeCareAdvisor and email prompts only.
Intervention Type
Behavioral
Intervention Name(s)
Immediate treatment group with High-Intensity Prompts
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Immediate treatment group with Low-Intensity Prompts
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control after three months with High-Intensity Prompts
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control after three months with Low-Intensity Prompts
Intervention Description
After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive email prompts.
Primary Outcome Measure Information:
Title
Short-term Change in Caregiver Distress with Behaviors
Description
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)
Time Frame
1 Month
Title
Long-term Change in Caregiver Distress with Behaviors (3-Months)
Description
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)
Time Frame
3 months
Title
Short-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
Description
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)
Time Frame
1 month
Title
Long-Term Change in Caregiver Confidence Managing Behavioral and Psychological Symptoms of Dementia
Description
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))
Time Frame
3 months
Title
Short-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors
Description
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)
Time Frame
1 Month
Title
Long-Term Change in Person Living with Dementia- Frequency and Severity of Behaviors
Description
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)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Short-Term Change in Person with Dementia- Level of Physical Dependence
Description
Caregivers will identify the staging of functionality that the person of living with dementia has, using the Functional Assessment Staging (FAST) scale.
Time Frame
1 months
Title
Long-Term Term Change in Person with Dementia- Level of Physical Dependence
Description
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
Time Frame
3 months
Title
Short-Term Change in Person with Dementia- Level of Functioning
Description
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)
Time Frame
1 months
Title
Long-Term Change in Person with Dementia- Level of Functioning
Description
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)
Time Frame
3 months
Title
Change in Person with Dementia's Medications
Description
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).
Time Frame
6 months
Title
Short-term Change in Caregiver's Depressive Symptoms
Description
Caregiver depression will be measured using the Patient Health Questionnaire (PHQ-8), scoring from 0-27, with higher scores indicating higher levels of depression.
Time Frame
1 month
Title
Long-term Change in Caregiver's Depressive Symptoms
Description
Caregiver depression will be measured using the Patient Health Questionnaire (PHQ-8), scoring from 0-27, with higher scores indicating higher levels of depression
Time Frame
3 months
Title
Short Term Change in Caregiver Wellbeing
Description
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.
Time Frame
1 Month
Title
Long Term Change in Caregiver Wellbeing
Description
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.
Time Frame
3 Months
Title
Short Term Change in Caregiver- Negative Communications
Description
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).
Time Frame
1 Month
Title
Long Term Change in Caregiver- Negative Communications
Description
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).
Time Frame
3 Month
Title
Utilization of tool use
Description
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.
Time Frame
Through study completion, up to 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WeCareAdvisor Study Team
Phone
267-359-1111
Email
wecare@drexel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura N Gitlin, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen C Kales, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WeCareAdvisor Study Team
Email
wecare@drexel.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be stored after 7 years following completion of study and reporting of main outcomes.
Citations:
PubMed Identifier
33786370
Citation
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.
Results Reference
background
PubMed Identifier
28800895
Citation
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.
Results Reference
result
PubMed Identifier
29747583
Citation
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.
Results Reference
result
Learn more about this trial
WeCareAdvisor Study for Caregivers of People Living With Dementia
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