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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587583
• Other study ID #: HUM00117707
• Secondary ID: W81XWH-16-1-0551
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 19, 2020
• Est. completion date: October 21, 2021

Study information

• Verified date: March 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioral Symptoms
• Caregiver
• Dementia
• Memory Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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