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Completed

NCT Number: NCT04587583

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).

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Key information

Conditions

Dementia Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Caregiver Central Nervous System Diseases Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WeCareAdvisor

Behavioral

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 outcomes

  1. Change in Caregiver Stress

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Caregiver Communication

    Time frame: 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 outcomes

  1. Ease of Use of the WeCareAdvisor Tool

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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