Neuro-Degenerative DiseaseEmpathyNCT04635540
Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease
A study testing Educational Brochure in people with Neuro-Degenerative Disease and Dementia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 95 years
- Conditions the study is for
- Neuro-Degenerative Disease, Dementia, Caregiver Burnout
- What is being tested?
- Educational Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jul 2019to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
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
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.
Read the 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.
- Conditions
- Neuro-Degenerative Disease, Dementia, Caregiver Burnout, Alzheimer Disease, Frontotemporal Lobar Degeneration, Parkinson Disease
- Being tested
- Educational Brochure
- Medical subject headings
- Dementia, Caregiver Burden, Alzheimer Disease, Frontotemporal Lobar Degeneration, Parkinson Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational BrochureBehavioural
Educational brochure on decreased empathy and emotion recognition in patients with neurodegenerative disease
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | The Interventional Arm will receive the educational brochure and complete the study tasks and questionnaires. Receives: Behavioral: Educational Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Visit
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.
Measured: Baseline Visit
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.
Measured: Baseline Visit and 1 month after the Baseline visit
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.
Measured: Baseline Visit
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.
Measured: Baseline Visit
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.
Measured: Baseline Visit
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.
Measured: Baseline Visit
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.
Measured: Baseline Visit and 1 month after the Baseline Visit
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.
Measured: Baseline Visit and 1 month after the Baseline Visit
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.
Measured: Baseline Visit and 1 month after the Baseline Visit
Secondary outcomes (3)
Recruitment Rate
Number of individuals signing consent/number of individuals approached
Measured: through study completion, an average of 1 year
Retention Rate
Number of those who remain in study/number of participants who have signed consent at the beginning of the study
Measured: through study completion, an average of 1 year
Completion Rate
Number of dyads with completed questionnaire/total subject population (For a questionnaire to be complete, every question must be answered).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start22 Jul 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmela Tartaglia, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635540
- Sponsor's protocol ID
- 18-6350
- Acronym
- Empathy
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04635540
- Acronym / sponsor ID
- Empathy / 18-6350
- Conditions
- Neuro-Degenerative Disease, Dementia, Caregiver Burnout, Alzheimer Disease, Frontotemporal Lobar Degeneration, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every caregiver and patient dyad will complete the study tasks. The caregiver will receive a 1 month follow up call.
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Behavioral: Educational BrochureThe Interventional Arm will receive the educational brochure and complete the study tasks and questionnaires. |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational BrochureEducational brochure on decreased empathy and emotion recognition in patients with neurodegenerative disease | Behavioural | Interventional Arm |
Primary outcome
Abbreviated form of the Emotion Evaluation Test (EET) from The Awareness of Social Inference Test (TASIT)
Time frame: Baseline Visit
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
Time frame: Baseline Visit
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
Time frame: Baseline Visit and 1 month after the Baseline visit
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
Time frame: Baseline Visit
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
Time frame: Baseline Visit
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
Time frame: Baseline Visit
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
Time frame: Baseline Visit
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
Time frame: Baseline Visit and 1 month after the Baseline Visit
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
Time frame: Baseline Visit and 1 month after the Baseline Visit
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
Time frame: Baseline Visit and 1 month after the Baseline Visit
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.
3 secondary outcomes
Recruitment Rate
Time frame: through study completion, an average of 1 year
Retention Rate
Time frame: through study completion, an average of 1 year
Completion Rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmela Tartaglia, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Brochure in people with Neuro-Degenerative Disease and Dementia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbreviated form of the Emotion Evaluation Test (EET) from The Awareness of Social Inference Test (TASIT) (time frame: Baseline Visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.