An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia

Study Overview
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Brief Summary
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Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors. The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to 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. This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.

Official Title
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An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Immediately Receive Tool
* Behavioral: One Month Delay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Age 21 years or older Ability to read, speak and understand English Home location within 50 miles of the study site Caregivers (CG) Active primary caregiver of a Person with Dementia (PwD) for at least 6 months and planning to remain the primary caregiver for the next 2 months Currently living with the PwD CG plans to live in the area for the duration of the study Is familiar and comfortable utilizing technology (e.g. computers, tablets, the internet) Persons with Dementia (PwD) CG reports that the PwD exhibits at least one or more behavioral symptoms (any behavior at any frequency) PwD receiving psychotropic medication or cognitive enhancers will not be excluded. If PwD is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that he/she have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications. Clinical diagnosis of dementia (any type) or a score of less than 24 on the Mini-Mental State Examination (MMSE) Exclusion Criteria: General Inability to read, speak or understand English Home location greater than 50 miles from the study site Lack of regular access to a telephone Caregivers (CG) Reading literacy of less than 6th grade Visual impairment to the extent of prohibiting interaction with the tool Hearing impairment sufficient to prohibit telephone communication Other self-identified mental or physical health issues that would distinctly interfere with the ability to reasonably test the tool or complete behavioral interventions (e.g. substance use disorder, schizophrenia, severe mobility issues) Hospitalized more than 3 times in the past year Participating in another study to help caregivers care for the person with dementia. Persons with Dementia (PwD) At a terminal phase of illness, unable to respond to the environment or with a life expectancy less than 6 months Active suicide risk Imminent placement to nursing home (within the next 60 days) Hospitalized more than 3 times in the past year Currently in another study testing a medication to control behavioral symptoms

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediately Receive Tool<br>Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks. | Behavioral: Immediately Receive Tool<br> <br> |
| Active Comparator: One Month Delay<br>Caregiver/Care Recipient Dyad will be randomly assigned to a 4 week delay (usual care activities only) before receiving the WeCareAdvisor Tool for 4 weeks. | Behavioral: One Month Delay<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of the WeCareAdvisor Tool on Caregiver Upset | We will measure caregiver upset on a 5 point rating scale not at all, a little, moderately, very much and extremely | 4 weeks | 
| Effect of the WeCareAdvisor Tool on Caregiver Confidence | We will measure caregiver confidence on a 5 point rating scale not at all, a little, moderately, very much and extremely | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Alzheimer's Disease, Caregivers, Behavioral, Caregiver burden