NCT02420535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

April 14, 2015

Last Update Submit

December 15, 2016

Conditions

Dementia

Keywords

DementiaAlzheimer's DiseaseCaregiversBehavioralCaregiver burden

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Immediately Receive Tool

EXPERIMENTAL

Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.

Behavioral: Immediately Receive Tool

One Month Delay

ACTIVE COMPARATOR

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

Interventions

Immediately Receive ToolBEHAVIORAL
Immediately Receive Tool
One Month DelayBEHAVIORAL
One Month Delay

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

University of Michigan Department of Psychiatry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • 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.

    PMID: 33417236DERIVED

  • 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.

    PMID: 29747583DERIVED

  • 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.

    PMID: 28800895DERIVED

MeSH Terms

Conditions

DementiaAlzheimer DiseaseBehaviorCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesStress, PsychologicalBehavioral Symptoms

Study Officials

  • Helen Kales, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Laura Gitlin, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry, Director, The Program for Positive Aging Research, Associate Director for Mental Health and Aging Research,The Geriatrics Center

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 20, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations

US(2)