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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02420535
• Collaborator: Johns Hopkins University (Other)
• Enrollment: 114
• Locations: 2
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site: 57
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Immediately Receive Tool; Behavioral: One Month Delay	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediately Receive Tool Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.	Behavioral: Immediately Receive Tool
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.	Behavioral: One Month Delay

Outcome Measures

Primary Outcome Measures

1. 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"

2. 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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Nursing	Baltimore	Maryland	United States	21205
2	University of Michigan Department of Psychiatry	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Johns Hopkins University

Investigators

• Principal Investigator: Helen Kales, MD, University of Michigan
• Principal Investigator: Laura Gitlin, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helen Kales, Professor of Psychiatry, Director, The Program for Positive Aging Research, Associate Director for Mental Health and Aging Research,The Geriatrics Center, University of Michigan
• ClinicalTrials.gov Identifier: NCT02420535
• Other Study ID Numbers: HUM00066639
• First Posted: Apr 20, 2015
• Last Update Posted: Dec 19, 2016
• Last Verified: Dec 1, 2016

• Keywords provided by Helen Kales, Professor of Psychiatry, Director, The Program for Positive Aging Research, Associate Director for Mental Health and Aging Research,The Geriatrics Center, University of Michigan: Dementia; Alzheimer's Disease; Caregivers; Behavioral; Caregiver burden
• Additional relevant MeSH terms: Dementia; Behavioral Symptoms

Study Results

No Results Posted as of Dec 19, 2016