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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediately Receive Tool
One Month Delay
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Dementia, Alzheimer's Disease, Caregivers, Behavioral, Caregiver burden

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins School of Nursing
  • University of Michigan Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediately Receive Tool

One Month Delay

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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"
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"

Secondary Outcome Measures

Full Information

First Posted
April 14, 2015
Last Updated
December 15, 2016
Sponsor
University of Michigan
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02420535
Brief Title
An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
Official Title
An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Alzheimer's Disease, Caregivers, Behavioral, Caregiver burden

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediately Receive Tool
Arm Type
Experimental
Arm Description
Caregiver/Care Recipient Dyad will be randomly assigned to immediately receive the WeCareAdvisor Tool for 4 weeks.
Arm Title
One Month Delay
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Immediately Receive Tool
Intervention Type
Behavioral
Intervention Name(s)
One Month Delay
Primary Outcome Measure Information:
Title
Effects of the WeCareAdvisor Tool on Caregiver Upset
Description
We will measure caregiver upset on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
Time Frame
4 weeks
Title
Effect of the WeCareAdvisor Tool on Caregiver Confidence
Description
We will measure caregiver confidence on a 5 point rating scale "not at all", "a little", "moderately", "very much" and "extremely"
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Kales, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Gitlin, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Michigan Department of Psychiatry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33417236
Citation
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.
Results Reference
derived
PubMed Identifier
29747583
Citation
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.
Results Reference
derived
PubMed Identifier
28800895
Citation
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.
Results Reference
derived

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

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