Clinical trial NCT02420535: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Alzheimer's Disease
Caregivers
Behavioral
Caregiver burden
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2015-04-20
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Effects of the WeCareAdvisor Tool on Caregiver Upset
timeFrame: 4 weeks
measure: Effect of the WeCareAdvisor Tool on Caregiver Confidence
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Department of Psychiatry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Helen Kales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Laura Gitlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.