Clinical trial NCT04635540: Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease
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
Overall status: UNKNOWN
Phase: NA
Conditions: Neuro-Degenerative Disease
Dementia
Caregiver Burnout
Alzheimer Disease
Frontotemporal Lobar Degeneration
Parkinson Disease
Vascular Dementia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every caregiver and patient dyad will complete the study tasks. The caregiver will receive a 1 month follow up call.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Abbreviated form of the Emotion Evaluation Test (EET) from The Awareness of Social Inference Test (TASIT)
timeFrame: Baseline Visit
measure: Value of educational material
timeFrame: Baseline Visit
measure: Change in understanding before and after reading the educational material
timeFrame: Baseline Visit and 1 month after the Baseline visit
measure: Caregiver empathy assessment of patient
timeFrame: Baseline Visit
measure: Caregiver functional assessment of patient
timeFrame: Baseline Visit
measure: Caregiver neuropsychiatric assessment of patient
timeFrame: Baseline Visit
measure: Caregiver staging of dementia severity assessment of patient
timeFrame: Baseline Visit
measure: Change in caregiver burden at 1 month
timeFrame: Baseline Visit and 1 month after the Baseline Visit
measure: Change in caregiver mood symptoms at 1 month
timeFrame: Baseline Visit and 1 month after the Baseline Visit
measure: Change in caregiver quality of life at 1 month
timeFrame: Baseline Visit and 1 month after the Baseline Visit
Secondary outcomes:
measure: Recruitment Rate
timeFrame: through study completion, an average of 1 year
measure: Retention Rate
timeFrame: through study completion, an average of 1 year
measure: Completion Rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Carmela Tartaglia, MD
role: PRINCIPAL_INVESTIGATOR
References: