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Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease (Empathy)

Primary Purpose

Neuro-Degenerative Disease, Dementia, Caregiver Burnout

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational Brochure
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuro-Degenerative Disease

Eligibility Criteria

30 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital, University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Abbreviated form of the Emotion Evaluation Test (EET) from The Awareness of Social Inference Test (TASIT)
Subjects watch brief (∼ 20s) videos of actors performing semantically neutral scripts portraying one of the seven basic emotions (happy, surprised, neutral, sad, anxious, frightened, revolted), and must choose the correct emotion. The maximum score is 14 and lower scores on this test indicate greater impairment in emotion recognition. Patients and caregivers will be tested separately in a quiet room. No feedback is provided after each clip. Caregivers will be asked to predict the patient's response after each clip. A caregiver accuracy score will be computed by subtracting the patient's actual TASIT-EET score and the caregiver's predicted TASIT-EET score.
Value of educational material
The caregivers will rate the brochure's quality by answering a 7-item questionnaire. The maximum score is 35, with higher scores indicating better quality and helpfulness of the educational brochure.
Change in understanding before and after reading the educational material
The caregivers will rate their understanding of decreased empathy and emotion recognition changes in people with neurodegenerative disease by answering a 5-item questionnaire. The maximum score is 25 and higher scores will indicate that the caregiver perceives the patient as capable of recognizing the emotions of other people very well.
Caregiver empathy assessment of patient
Empathy will be evaluated using the Interpersonal Reactivity Index (IRI), which measures both the cognitive and emotional aspects of empathy. Informants fill out a 28-item self report questionnaire describing the subject's current characteristics. Scores range from 28-140. Higher scores indicate better performance.
Caregiver functional assessment of patient
Functional capacity will be evaluated with the Functional Activities Questionnaire (FAQ). Informants fill out a 10-item questionnaire describing the patient's current functional capacity. Scores range from 0-30 with a cut-off score of 9 indicating impaired function and possible cognitive impairment.
Caregiver neuropsychiatric assessment of patient
The neuropsychiatric inventory (NPI) will be administered to caregivers to assess neuropsychiatric symptoms (NPS) in individuals with dementia. The NPI assesses the presence of the following NPS over the period of four weeks: delusions, hallucinations, agitation, depression/dysphoria, anxiety, euphoria/elation, apathy indifference, disinhibition, irritability/lability, aberrant motor behaviour, sleep, and appetite and eating disorder. Caregivers are asked about the frequency (4-point scale) and severity (3-point scale) of these symptoms and on caregiver distress. A total score for each symptom is obtained by multiplying the frequency and severity score, giving a maximum score of 144 with higher scores reflecting increased frequency and severity of NPS. Lastly, caregiver distress is rated on a 6-point scale.
Caregiver staging of dementia severity assessment of patient
The Clinical Dementia Rating Scale (CDR) modified version assesses 8 domains of global dementia using a five-point scale, including: memory, orientation, judgment/problem solving, community affairs, home and hobbies, personal care, behavioural comportment and personality, and language. It is used as a staging scale to assess the severity of dementia. It is performed through a semi-structured analysis with a caregiver. The CDR sum of boxes will be used in the analysis. The maximum sum of boxes is 24 with higher scores showing increased impairment.
Change in caregiver burden at 1 month
The Zarit Burden Inventory (ZBI) assesses caregiver burden in individuals caring for patients with dementia. The caregivers filled out a 22-item ZBI questionnaire to evaluate the amount of stress experienced by them due to the person's dementia. Each item is rated on a 5-point scale, and a total score is calculated by taking the sum of individual statements. The score ranges from 0-88 and higher scores on the ZBI indicates increased burden. The change in score from the initial appointment and 1 month follow up will be used in analysis.
Change in caregiver mood symptoms at 1 month
The Geriatric Depression Scale (GDS) assesses mood and depression in geriatric patients and will be used for caregivers 50 years old and above. Scores range from 0-15 with higher scores indicating greater symptoms of depression. The Depression Anxiety Stress Scale (DASS) assesses depression, anxiety, and stress and can be used in adults and geriatric patients. The DASS will be used for all caregivers aged 30 years and above. Scores range from 0-63 with higher scores indicating increased symptoms of depression. The change in score from the initial appointment and 1 month follow up will be used in analysis.
Change in caregiver quality of life at 1 month
The World Health Organization Quality of Life (WHOQOL-BREF) is a 26-item, self-reported quality of life measure, which measures quality of life in four domains: physical health, psychological health, social relationships, and environment. Answers are rated on a scale of 1-5, where numbers can be in order of increasing satisfaction or decreasing satisfaction depending on the domain and questionnaire item. The score range is from 26-130 with higher scores indicating increased quality of life satisfaction. The change in score from the initial appointment and 1 month follow up will be used in analysis.

Secondary Outcome Measures

Recruitment Rate
Number of individuals signing consent/number of individuals approached
Retention Rate
Number of those who remain in study/number of participants who have signed consent at the beginning of the study
Completion Rate
Number of dyads with completed questionnaire/total subject population (For a questionnaire to be complete, every question must be answered).

Full Information

First Posted
March 30, 2020
Last Updated
April 26, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04635540
Brief Title
Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease
Acronym
Empathy
Official Title
A Pilot Study Assessing the Benefits of a Dementia Caregiver Educational Brochure on Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuro-Degenerative Disease, Dementia, Caregiver Burnout, Alzheimer Disease, Frontotemporal Lobar Degeneration, Parkinson Disease, Vascular Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every caregiver and patient dyad will complete the study tasks. The caregiver will receive a 1 month follow up call.
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
The Interventional Arm will receive the educational brochure and complete the study tasks and questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Educational Brochure
Intervention Description
Educational brochure on decreased empathy and emotion recognition in patients with neurodegenerative disease
Primary Outcome Measure Information:
Title
Abbreviated form of the Emotion Evaluation Test (EET) from The Awareness of Social Inference Test (TASIT)
Description
Subjects watch brief (∼ 20s) videos of actors performing semantically neutral scripts portraying one of the seven basic emotions (happy, surprised, neutral, sad, anxious, frightened, revolted), and must choose the correct emotion. The maximum score is 14 and lower scores on this test indicate greater impairment in emotion recognition. Patients and caregivers will be tested separately in a quiet room. No feedback is provided after each clip. Caregivers will be asked to predict the patient's response after each clip. A caregiver accuracy score will be computed by subtracting the patient's actual TASIT-EET score and the caregiver's predicted TASIT-EET score.
Time Frame
Baseline Visit
Title
Value of educational material
Description
The caregivers will rate the brochure's quality by answering a 7-item questionnaire. The maximum score is 35, with higher scores indicating better quality and helpfulness of the educational brochure.
Time Frame
Baseline Visit
Title
Change in understanding before and after reading the educational material
Description
The caregivers will rate their understanding of decreased empathy and emotion recognition changes in people with neurodegenerative disease by answering a 5-item questionnaire. The maximum score is 25 and higher scores will indicate that the caregiver perceives the patient as capable of recognizing the emotions of other people very well.
Time Frame
Baseline Visit and 1 month after the Baseline visit
Title
Caregiver empathy assessment of patient
Description
Empathy will be evaluated using the Interpersonal Reactivity Index (IRI), which measures both the cognitive and emotional aspects of empathy. Informants fill out a 28-item self report questionnaire describing the subject's current characteristics. Scores range from 28-140. Higher scores indicate better performance.
Time Frame
Baseline Visit
Title
Caregiver functional assessment of patient
Description
Functional capacity will be evaluated with the Functional Activities Questionnaire (FAQ). Informants fill out a 10-item questionnaire describing the patient's current functional capacity. Scores range from 0-30 with a cut-off score of 9 indicating impaired function and possible cognitive impairment.
Time Frame
Baseline Visit
Title
Caregiver neuropsychiatric assessment of patient
Description
The neuropsychiatric inventory (NPI) will be administered to caregivers to assess neuropsychiatric symptoms (NPS) in individuals with dementia. The NPI assesses the presence of the following NPS over the period of four weeks: delusions, hallucinations, agitation, depression/dysphoria, anxiety, euphoria/elation, apathy indifference, disinhibition, irritability/lability, aberrant motor behaviour, sleep, and appetite and eating disorder. Caregivers are asked about the frequency (4-point scale) and severity (3-point scale) of these symptoms and on caregiver distress. A total score for each symptom is obtained by multiplying the frequency and severity score, giving a maximum score of 144 with higher scores reflecting increased frequency and severity of NPS. Lastly, caregiver distress is rated on a 6-point scale.
Time Frame
Baseline Visit
Title
Caregiver staging of dementia severity assessment of patient
Description
The Clinical Dementia Rating Scale (CDR) modified version assesses 8 domains of global dementia using a five-point scale, including: memory, orientation, judgment/problem solving, community affairs, home and hobbies, personal care, behavioural comportment and personality, and language. It is used as a staging scale to assess the severity of dementia. It is performed through a semi-structured analysis with a caregiver. The CDR sum of boxes will be used in the analysis. The maximum sum of boxes is 24 with higher scores showing increased impairment.
Time Frame
Baseline Visit
Title
Change in caregiver burden at 1 month
Description
The Zarit Burden Inventory (ZBI) assesses caregiver burden in individuals caring for patients with dementia. The caregivers filled out a 22-item ZBI questionnaire to evaluate the amount of stress experienced by them due to the person's dementia. Each item is rated on a 5-point scale, and a total score is calculated by taking the sum of individual statements. The score ranges from 0-88 and higher scores on the ZBI indicates increased burden. The change in score from the initial appointment and 1 month follow up will be used in analysis.
Time Frame
Baseline Visit and 1 month after the Baseline Visit
Title
Change in caregiver mood symptoms at 1 month
Description
The Geriatric Depression Scale (GDS) assesses mood and depression in geriatric patients and will be used for caregivers 50 years old and above. Scores range from 0-15 with higher scores indicating greater symptoms of depression. The Depression Anxiety Stress Scale (DASS) assesses depression, anxiety, and stress and can be used in adults and geriatric patients. The DASS will be used for all caregivers aged 30 years and above. Scores range from 0-63 with higher scores indicating increased symptoms of depression. The change in score from the initial appointment and 1 month follow up will be used in analysis.
Time Frame
Baseline Visit and 1 month after the Baseline Visit
Title
Change in caregiver quality of life at 1 month
Description
The World Health Organization Quality of Life (WHOQOL-BREF) is a 26-item, self-reported quality of life measure, which measures quality of life in four domains: physical health, psychological health, social relationships, and environment. Answers are rated on a scale of 1-5, where numbers can be in order of increasing satisfaction or decreasing satisfaction depending on the domain and questionnaire item. The score range is from 26-130 with higher scores indicating increased quality of life satisfaction. The change in score from the initial appointment and 1 month follow up will be used in analysis.
Time Frame
Baseline Visit and 1 month after the Baseline Visit
Secondary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of individuals signing consent/number of individuals approached
Time Frame
through study completion, an average of 1 year
Title
Retention Rate
Description
Number of those who remain in study/number of participants who have signed consent at the beginning of the study
Time Frame
through study completion, an average of 1 year
Title
Completion Rate
Description
Number of dyads with completed questionnaire/total subject population (For a questionnaire to be complete, every question must be answered).
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmela Tartaglia, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease

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