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



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:May 2015
End Date:May 2016
Contact:Barbara Stanislawski, MPH, MSW
Email:bstanisl@med.umich.edu
Phone:734-232-0323

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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.


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
We found this trial at
2
sites
Baltimore, Maryland 21205
Principal Investigator: Laura Gitlin, PhD
Phone: 443-287-8633
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Baltimore, MD
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Ann Arbor, Michigan 48109
Principal Investigator: Helen Kales, MD
Phone: 734-232-0323
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Ann Arbor, MI
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