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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT04587583
Collaborator
United States Department of Defense (U.S. Fed)
19
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2
12.1
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Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WeCareAdvisor
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
Actual Study Start Date :
Oct 19, 2020
Actual Primary Completion Date :
Oct 21, 2021
Actual Study Completion Date :
Oct 21, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Caregiver Stress [Baseline to 2 months]

    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.

  2. Change in Caregiver Confidence in Managing Problematic Behavior [Baseline to 2 months]

    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

  3. Change in Caregiver Upset [Baseline to 2 months]

    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

  1. Change in Caregiver Communication [Baseline to 2 months]

    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.

Other Outcome Measures

  1. Ease of Use of the WeCareAdvisor Tool [1 month after using 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).

  2. Usefulness/ Perceived Benefit of the WeCareAdvisor Tool [1 month after using 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • United States Department of Defense

Investigators

  • Principal Investigator: Frederic C Blow, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frederic C. Blow, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier:
NCT04587583
Other Study ID Numbers:
  • HUM00117707
  • W81XWH-16-1-0551
First Posted:
Oct 14, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022