WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers

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).

Study Overview

• Status: Completed
• Conditions: Behavioral Symptoms; Dementia; Alzheimer Disease; Memory Disorders; Caregiver
• Intervention / Treatment: Behavioral: WeCareAdvisor

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WeCareAdvisor; immediate use of the WeCareAdvisor tool for a 1 month period	Behavioral: WeCareAdvisor; 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.
Active Comparator: WeCareAdvisor after 1 month; after a wait period of 1 month, use of the WeCareAdvisor tool for a 1 month period	Behavioral: WeCareAdvisor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 2 months
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	Baseline to 2 months
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).	Baseline to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Use of the WeCareAdvisor Tool	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).	1 month after using WeCareAdvisor tool
Usefulness/ Perceived Benefit of the WeCareAdvisor Tool	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).	1 month after using WeCareAdvisor tool

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Behavioral Symptoms; Memory Disorders
• Other Study ID Numbers: HUM00117707; W81XWH-16-1-0551 (Other Grant/Funding Number: United States Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No