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

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: One Month Delay; Behavioral: Immediately Receive Tool

• Registration Number: NCT02420535
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-20
• Study Start: 2015-05
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
One Month Delay	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.
Immediately Receive Tool	Immediately Receive Tool	Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Effects of the WeCareAdvisor Tool on Caregiver Upset	4 weeks	We will measure caregiver upset on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
Effect of the WeCareAdvisor Tool on Caregiver Confidence	4 weeks	We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"

Trial Locations

Locations (2)

University of Michigan Department of Psychiatry; 🇺🇸 Ann Arbor, Michigan, United States

Johns Hopkins School of Nursing; 🇺🇸 Baltimore, Maryland, United States