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

Overview

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.

Primary outcome measures

• Change in the Stroke Impact Scale (version 3.0) [Time frame: three, six and 12 months after stroke]

Secondary outcome measures (7)

• Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported) [Time frame: three, six and 12 months after stroke]
• Change of the Barthel Index of Activities of Daily Living (self-reported) [Time frame: three, six and 12 months after stroke]
• Change of Modified Rankin Scale (self-reported) [Time frame: three, six and 12 months after stroke]
• Change of post-stroke depression and anxiety (self-reported) [Time frame: three, six and 12 months after stroke]
• Change of the Montreal Cognitive Assessment (MoCA) [Time frame: three, six and 12 months after stroke]
• Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months. [Time frame: three and 12 months after stroke]
• Change in the NIH Stroke Scale (NIHSS) [Time frame: three, six and 12 months after stroke]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Czechia · 1 center

• Palacky University, Faculty of Health Sciences — Olomouc

Publications

• Arntz RM, van Alebeek ME, Synhaeve NE, Brouwers PJ, van Dijk GW, Gons RA, den Heijer T, de Kort PL, de Laat KF, van Norden AG, Vermeer SE, van der Vlugt MJ, Kessels RP, van Dijk EJ, de Leeuw FE. Observational Dutch Young Symptomatic StrokE studY (ODYSSEY): study rationale and protocol of a multicentre prospective cohort study. BMC Neurol. 2014 Mar 22;14:55. doi: 10.1186/1471-2377-14-55. PMID 24655479
• Bartholome L, Winter Y. Quality of Life and Resilience of Patients With Juvenile Stroke: A Systematic Review. J Stroke Cerebrovasc Dis. 2020 Oct;29(10):105129. doi: 10.1016/j.jstrokecerebrovasdis.2020.105129. Epub 2020 Jul 15. PMID 32912563
• Boot E, Ekker MS, Putaala J, Kittner S, De Leeuw FE, Tuladhar AM. Ischaemic stroke in young adults: a global perspective. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):411-417. doi: 10.1136/jnnp-2019-322424. Epub 2020 Feb 3. PMID 32015089
• de Bruijn MA, Synhaeve NE, van Rijsbergen MW, de Leeuw FE, Mark RE, Jansen BP, de Kort PL. Quality of Life after Young Ischemic Stroke of Mild Severity Is Mainly Influenced by Psychological Factors. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2183-8. doi: 10.1016/j.jstrokecerebrovasdis.2015.04.040. Epub 2015 Jul 26. PMID 26215135
• Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Kohler S. The Cognition and Affect after Stroke - a Prospective Evaluation of Risks (CASPER) study: rationale and design. BMC Neurol. 2016 May 12;16:65. doi: 10.1186/s12883-016-0588-1. PMID 27176617
• Ekker MS, Boot EM, Singhal AB, Tan KS, Debette S, Tuladhar AM, de Leeuw FE. Epidemiology, aetiology, and management of ischaemic stroke in young adults. Lancet Neurol. 2018 Sep;17(9):790-801. doi: 10.1016/S1474-4422(18)30233-3. PMID 30129475
• Harno H, Haapaniemi E, Putaala J, Haanpaa M, Makela JP, Kalso E, Tatlisumak T. Central poststroke pain in young ischemic stroke survivors in the Helsinki Young Stroke Registry. Neurology. 2014 Sep 23;83(13):1147-54. doi: 10.1212/WNL.0000000000000818. Epub 2014 Aug 15. PMID 25128182
• Heiberg G, Friborg O, Pedersen SG, Thrane G, Holm Stabel H, Feldbaek Nielsen J, Anke A. Post-stroke health-related quality of life at 3 and 12 months and predictors of change in a Danish and Arctic Norwegian Region. J Rehabil Med. 2020 Sep 8;52(9):jrm00096. doi: 10.2340/16501977-2716. PMID 32735024

Identifiers

NCT: NCT04839887 · NU21-09-00053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗