Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02420535
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02420535
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : December 19, 2016
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Helen Kales, 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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Immediately Receive Tool Behavioral: One Month Delay Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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



Primary Outcome Measures :
  1. Effects of the WeCareAdvisor Tool on Caregiver Upset [ Time Frame: 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 [ Time Frame: 4 weeks ]
    We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420535


Locations
Layout table for location information
United States, Maryland
Johns Hopkins School of Nursing
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan Department of Psychiatry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Helen Kales, MD University of Michigan
Principal Investigator: Laura Gitlin, PhD Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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     History of Changes
Other Study ID Numbers: HUM00066639
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Keywords provided by Helen Kales, University of Michigan:
Dementia
Alzheimer's Disease
Caregivers
Behavioral
Caregiver burden
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders