Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease

NCT ID: NCT04635540

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2022-07-31

Brief Summary

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This study evaluates an educational brochure tailored to caregivers of people with Alzheimer's disease, Parkinson's disease dementia, Lewy body disease, frontotemporal dementia, and vascular disease dementia. The goal of the brochure is educating caregivers about the decreased ability to detect emotion and decreased empathy that can be seen in dementia, increasing caregiver competence in providing care, and teaching caregivers ways to manage over time that lessens burden and improves quality of life.

Detailed Description

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The 1.5-hour initial visit will involve the caregiver completing questionnaires, structured interviews, and a computer task, and the person with dementia completing a computer task. A 20-30 minute follow-up phone call with the caregiver one month after the initial visit will involve completing questionnaires.

Conditions

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Neuro-Degenerative Disease Dementia Caregiver Burnout Alzheimer Disease Frontotemporal Lobar Degeneration Parkinson Disease Vascular Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Every caregiver and patient dyad will complete the study tasks. The caregiver will receive a 1 month follow up call.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Interventional Arm

The Interventional Arm will receive the educational brochure and complete the study tasks and questionnaires.

Group Type EXPERIMENTAL

Educational Brochure

Intervention Type BEHAVIORAL

Educational brochure on decreased empathy and emotion recognition in patients with neurodegenerative disease

Interventions

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Educational Brochure

Educational brochure on decreased empathy and emotion recognition in patients with neurodegenerative disease

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All caregivers who visit the UHN Memory Clinic with a patient with a neurodegenerative disease will be asked to participate.
* The patient must be aged 50 to 95 (inclusive) and speak English
* The caregiver must be aged 30 to 95 (inclusive) and speak English.
* The patients must have a diagnosis of one of the following conditions: Alzheimer's Disease, Parkinson's Disease/Dementia with Lewy Body, Frontotemporal Lobar Degeneration-syndromes or Vascular Dementia.
* The patient must have a Montreal Cognitive Assessment (MOCA) score of 10-25

Exclusion Criteria

* Not English speaking.
* Patients who do not have a caregiver that would be able to participate in the study.
* Caregivers who do not have a patient being followed at the UHN Memory Clinic
Minimum Eligible Age

30 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmela Tartaglia, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Informed Consent Form: Patient Consent Form

View Document

Document Type: Informed Consent Form: Caregiver Consent Form

View Document

Other Identifiers

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18-6350

Identifier Type: -

Identifier Source: org_study_id

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