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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420535
• Other study ID #: HUM00066639
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: December 15, 2016
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Behavioral Symptoms
• Dementia

Intervention

Behavioral:
• Immediately Receive Tool

• One Month Delay

Locations

Country	Name	City	State
United States	University of Michigan Department of Psychiatry	Ann Arbor	Michigan
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No