Back to resultsWeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
Primary Purpose
Dementia, Caregiver, Memory Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
WeCareAdvisor
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
Eligibility Criteria
Inclusion Criteria:
Eligible caregivers must:
- Be the primary caregiver of a military veteran with dementia for at least 6 months and planning to remain the primary caregiver for the next 2 months
- Currently living with the person they are caring for (care recipient)
- Comfortable utilizing technology (e.g. computers, tablets, the internet)
- Have access to the internet and a computer or tablet device
- Plans to live in the area for the duration of the study
Care recipients (military veteran living with dementia) must:
- Exhibit at least one or more behavioral symptoms (any behavior at any frequency)
- Receiving psychotropic medication or cognitive enhancers will not exclude the care recipient.
- Have a clinical diagnosis of dementia (any type) per caregiver report.
- Be a military veteran.
Exclusion Criteria:
- Inability to read, speak or understand English
- Lack of regular access to a telephone, internet, technology (tablet or computer)
- Caregiver is unable to use a computer or tablet
- Person with dementia is not a military veteran
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
WeCareAdvisor
WeCareAdvisor after 1 month
Arm Description
immediate use of the WeCareAdvisor tool for a 1 month period
after a wait period of 1 month, use of the WeCareAdvisor tool for a 1 month period
Outcomes
Primary Outcome Measures
Change in Caregiver Stress
As measured by a study specific questionnaire completed by caregivers. Stress is measured on a scale of 1 to 5 where 1 is equivalent to no stress and 5 is equivalent to extreme stress.
Change in Caregiver Confidence in Managing Problematic Behavior
As measured by a study specific questionnaire completed by caregivers. Confidence in managing problematic behavior is measured on a scale of 0 to 10, where a score of 0 means not confident and 10 means extremely confident
Change in Caregiver Upset
As measured by a study specific questionnaire completed by caregivers. Upset is measured on a scale of 0 to 5 where 0 is equivalent to no upset and 5 is equivalent to extreme upset (midpoint is equivalent to fairly upset).
Secondary Outcome Measures
Change in Caregiver Communication
Caregivers rate the frequency of using six forms of negative communication (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming), measured on a scale of 1 to 5 where a score of 1 is never and a score of 5 is always.
Full Information
NCT ID
NCT04587583
First Posted
October 7, 2020
Last Updated
March 29, 2022
Sponsor
University of Michigan
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04587583
Brief Title
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
Official Title
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. 60 caregiver-person with dementia dyads will be recruited (30 Treatment Group, 30 Wait-List Control Group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Caregiver, Memory Disorders, Alzheimer Disease, Behavioral Symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WeCareAdvisor
Arm Type
Active Comparator
Arm Description
immediate use of the WeCareAdvisor tool for a 1 month period
Arm Title
WeCareAdvisor after 1 month
Arm Type
Active Comparator
Arm Description
after a wait period of 1 month, use of the WeCareAdvisor tool for a 1 month period
Intervention Type
Behavioral
Intervention Name(s)
WeCareAdvisor
Intervention Description
Tailored, internet-based software intended to assess, manage and track behavioral symptoms and their contributing factors and to instruct dementia caregivers in problem solving approaches (tailored strategies for in-home, medication-free behavior management) to address difficult or disruptive behaviors exhibited by the person with dementia. During the testing period participants will refer to the WeCareAdvisor when behavioral challenges occur.
Primary Outcome Measure Information:
Title
Change in Caregiver Stress
Description
As measured by a study specific questionnaire completed by caregivers. Stress is measured on a scale of 1 to 5 where 1 is equivalent to no stress and 5 is equivalent to extreme stress.
Time Frame
Baseline to 2 months
Title
Change in Caregiver Confidence in Managing Problematic Behavior
Description
As measured by a study specific questionnaire completed by caregivers. Confidence in managing problematic behavior is measured on a scale of 0 to 10, where a score of 0 means not confident and 10 means extremely confident
Time Frame
Baseline to 2 months
Title
Change in Caregiver Upset
Description
As measured by a study specific questionnaire completed by caregivers. Upset is measured on a scale of 0 to 5 where 0 is equivalent to no upset and 5 is equivalent to extreme upset (midpoint is equivalent to fairly upset).
Time Frame
Baseline to 2 months
Secondary Outcome Measure Information:
Title
Change in Caregiver Communication
Description
Caregivers rate the frequency of using six forms of negative communication (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming), measured on a scale of 1 to 5 where a score of 1 is never and a score of 5 is always.
Time Frame
Baseline to 2 months
Other Pre-specified Outcome Measures:
Title
Ease of Use of the WeCareAdvisor Tool
Description
As measured by a study specific questionnaire completed by caregivers. Ease of use of the WeCareAdvisor tool is measured on a scale of 1 to 7 where 1 is equivalent to strongly disagree and 7 is equivalent to strongly agree (midpoint is equivalent to neutral).
Time Frame
1 month after using WeCareAdvisor tool
Title
Usefulness/ Perceived Benefit of the WeCareAdvisor Tool
Description
As measured by a study specific questionnaire completed by caregivers. Usefulness/perceived benefit of the WeCareAdvisor tool is measured on a scale of 1 to 7 where 1 is equivalent to strongly disagree and 7 is equivalent to strongly agree (midpoint is equivalent to neutral).
Time Frame
1 month after using WeCareAdvisor tool
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible caregivers must:
Be the primary caregiver of a military veteran with dementia for at least 6 months and planning to remain the primary caregiver for the next 2 months
Currently living with the person they are caring for (care recipient)
Comfortable utilizing technology (e.g. computers, tablets, the internet)
Have access to the internet and a computer or tablet device
Plans to live in the area for the duration of the study
Care recipients (military veteran living with dementia) must:
Exhibit at least one or more behavioral symptoms (any behavior at any frequency)
Receiving psychotropic medication or cognitive enhancers will not exclude the care recipient.
Have a clinical diagnosis of dementia (any type) per caregiver report.
Be a military veteran.
Exclusion Criteria:
Inability to read, speak or understand English
Lack of regular access to a telephone, internet, technology (tablet or computer)
Caregiver is unable to use a computer or tablet
Person with dementia is not a military veteran
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic C Blow, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
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