Clinical trial NCT04839887: Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults
Official title: Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults: a Prospective Observational Study in Young Ischemic Stroke Patients Under 50 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: Young Ischemic Stroke
Stroke recovery
Health-Related Quality of Life
Life Change Events
Life Experiences
Lead sponsor: Palacky University
Sponsor class: OTHER
Collaborators: name: University Hospital Olomouc
First posted: 2021-04-09
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from individuals, diagnosed with ischemic stroke according to the ICD-10 classification who will be admitted to the stroke unit.

Brief summary: Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Better identification and understanding to these factors may improve stroke rehabilitation and stroke self-management programmes, wich will lead to better stroke recovery. The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. In the second phase of study, 200 enrolled IS patients (100 young IS patients \< 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In the third phase of study, twenty young IS patients \< 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.

Detailed description: Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Fatigue, cognitive impairment, anxiety, depression, sexual dysfunction, loss of employment, social isolation, lack of specialist support, reduction in mobility and life roles, negative body image, impaired self-efficacy and self-esteem are considered most relevant factors. Investigation of predictors of post-stroke quality of life in young-onset patients is needed to design, implement, and evaluate specific young stroke rehabilitation and stroke self-management programmes.

The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. The aims of the study will be met by the triangulation of qualitative and quantitative research methods.

In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. In the second phase of study, 200 enrolled IS patients (100 young IS patients \< 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. In the third phase of study, twenty young IS patients \< 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke
* Age 18-65 years

Exclusion Criteria:

* Transient ischemic attack without progression to ischemic stroke
* Haemorrhagic stroke
* Severe cognitive impairment
* Severe communication disorder (sensory aphasia with the inability to understand having been verified by a certified speech therapist)
* Concomitant severe systemic illness
* Impaired ability to understand the questionnaires

Primary outcomes:
measure: Change in the Stroke Impact Scale (version 3.0)
timeFrame: three, six and 12 months after stroke
Secondary outcomes:
measure: Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported)
timeFrame: three, six and 12 months after stroke
measure: Change of the Barthel Index of Activities of Daily Living (self-reported)
timeFrame: three, six and 12 months after stroke
measure: Change of Modified Rankin Scale (self-reported)
timeFrame: three, six and 12 months after stroke
measure: Change of post-stroke depression and anxiety (self-reported)
timeFrame: three, six and 12 months after stroke
measure: Change of the Montreal Cognitive Assessment (MoCA)
timeFrame: three, six and 12 months after stroke
measure: Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months.
timeFrame: three and 12 months after stroke
measure: Change in the NIH Stroke Scale (NIHSS)
timeFrame: three, six and 12 months after stroke
Other outcomes:
measure: Change in the Fatigue Severity Scale
timeFrame: three, six and 12 months after stroke
measure: Change in the Brief Pain Inventory
timeFrame: three, six and 12 months after stroke
measure: Change in the Multi-dimensional Scale of Perceived Social Support
timeFrame: three, six and 12 months after stroke
Locations:
city: Olomouc
country: Czechia
facility: Palacky University, Faculty of Health Sciences
Study officials:
affiliation: Palacky University, Faculty of Health Sciences, Department of Nursing
name: Elena Gurkova, PhD
role: PRINCIPAL_INVESTIGATOR
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