An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
NCT ID: NCT02420535
Last Updated: 2016-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2015-05-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Immediately Receive Tool
Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.
Immediately Receive Tool
One Month Delay
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.
One Month Delay
Interventions
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Immediately Receive Tool
One Month Delay
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
University of Michigan
OTHER
Responsible Party
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Helen Kales
Professor of Psychiatry, Director, The Program for Positive Aging Research, Associate Director for Mental Health and Aging Research,The Geriatrics Center
Principal Investigators
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Helen Kales, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Laura Gitlin, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins School of Nursing
Baltimore, Maryland, United States
University of Michigan Department of Psychiatry
Ann Arbor, Michigan, United States
Countries
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References
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Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
Kales HC, Gitlin LN, Stanislawski B, Myra Kim H, Marx K, Turnwald M, Chiang C, Lyketsos CG. Effect of the WeCareAdvisor on family caregiver outcomes in dementia: a pilot randomized controlled trial. BMC Geriatr. 2018 May 10;18(1):113. doi: 10.1186/s12877-018-0801-8.
Gitlin LN, Kales HC, Marx K, Stanislawski B, Lyketsos C. A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor. Contemp Clin Trials. 2017 Nov;62:27-36. doi: 10.1016/j.cct.2017.08.001. Epub 2017 Aug 9.
Other Identifiers
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HUM00066639
Identifier Type: -
Identifier Source: org_study_id