- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420535
An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
December 15, 2016 updated by: Helen Kales, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Nursing
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Psychiatry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediately Receive Tool
Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.
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Active Comparator: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of the WeCareAdvisor Tool on Caregiver Upset
Time Frame: 4 weeks
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We will measure caregiver upset on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
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4 weeks
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Effect of the WeCareAdvisor Tool on Caregiver Confidence
Time Frame: 4 weeks
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We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
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4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Helen Kales, MD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
April 14, 2015
First Submitted That Met QC Criteria
April 14, 2015
First Posted (Estimate)
April 20, 2015
Study Record Updates
Last Update Posted (Estimate)
December 19, 2016
Last Update Submitted That Met QC Criteria
December 15, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00066639
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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