Ischemic Stroke
Conditions
Keywords
Young Ischemic Stroke, Stroke recovery, Health-Related Quality of Life, Life Change Events, Life Experiences
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.
Interventions
None listed
Sponsors
University Hospital Olomouc
Elena Gurkova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Stroke Impact Scale (version 3.0) | three, six and 12 months after stroke | Assessment of the impact of stroke on eight domains relating to self-rated quality of life, self-perceived disability, and global recovery after stroke (i.e., strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation). Scores for each domain range from 0 to 100, and higher scores indicate a better health related quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Modified Rankin Scale (self-reported) | three, six and 12 months after stroke | Scale used for measuring the degree of disability or dependence in the daily activities in patients after stroke. Most widely used clinical outcome measure after stroke. Scale has six points and higher score means worse outcome; minimum is 0 points indicating no symptoms at all and maximum is 6 points indicating death. |
| Change of the Montreal Cognitive Assessment (MoCA) | three, six and 12 months after stroke | Assessment of cognitive functions (cognitive test measuring specific cognitive domains). The MoCA generates a total score and six domain-specific index scores: Memory, Executive Functioning, Attention, Language, Visuospatial, and Orientation. MoCA score range between 0 and 30. Higher score indicates better cognitive functions. The following ranges are used to grade the severity of cognitive impairment: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment. |
| Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months. | three and 12 months after stroke | Semi-structured interviews with stroke patients |
| Change in the NIH Stroke Scale (NIHSS) | three, six and 12 months after stroke | NIHSS is used to objectively quantify the impairment caused by a stroke. Higher score indicates more severe neurological deficit. |
| Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported) | three, six and 12 months after stroke | Assessment of four domains relating to quality of life (Physical health, Psychological domain, Social relationships, Environment). The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The domain scores will be transformed in accordance with two transformation methods outlined in the WHOQOL-BREF scoring instructions. The domain scores will be transformed into scores ranging between 4 and 20 points (the first transformation method) or into a linear scale between 0 and 100 points (the second transformation method) |
| Change of the Barthel Index of Activities of Daily Living (self-reported) | three, six and 12 months after stroke | Measure of performance in activities of daily living. Measure of performance in activities of daily living. Scores of 10 personal activities range from 0 to 100 points and higher score indicates greater independence. |
| Change of post-stroke depression and anxiety (self-reported) | three, six and 12 months after stroke | Assessment of depressive and anxiety symptoms using Beck Depression Inventory II and Hospital Anxiety and Depression Scale. Higher total scores indicate more severe depressive symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Multi-dimensional Scale of Perceived Social Support | three, six and 12 months after stroke | The Multi-dimensional Scale of Perceived Social Support (MSPSS) assesses different sources of support. The MSPSS is a brief 12-item, self-administered measurement tool with three subscales: Family, Friends, and Significant Others. A higher score indicates greater social support perceived by an individual; the total possible score ranges between 12 and 84 points. |
| Change in the Fatigue Severity Scale | three, six and 12 months after stroke | Assessment of post-stroke fatigue using Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. The minimum score is nine and the highest is 63 points. The higher score indicates more severe fatigue and greater affecting of the person's activities. |
| Change in the Brief Pain Inventory | three, six and 12 months after stroke | Includes questions on site of pain, severity of pain, and how pain interfered with the patient's mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. These questions are rated on a scale of 0 to 10; a higher score indicates greater pain or greater interference with the daily activities. |
Countries
Czechia
Contacts
Primary ContactElena Gurkova, PhD
Backup ContactDaniel Sanak, MD, PhD
Outcome results
None listed