Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults

NCT04839887 | Recruiting

• 1 other identifier: NU21-09-00053
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Young Ischemic Stroke; Stroke recovery; Health-Related Quality of Life; Life Change Events; Life Experiences

Outcome Measures

Primary Outcomes (1)

• Change in the Stroke Impact Scale (version 3.0)

  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

  three, six and 12 months after stroke

Secondary Outcomes (7)

• Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported)

  three, six and 12 months after stroke

• Change of the Barthel Index of Activities of Daily Living (self-reported)

  three, six and 12 months after stroke

• Change of Modified Rankin Scale (self-reported)

  three, six and 12 months after stroke

• Change of post-stroke depression and anxiety (self-reported)

  three, six and 12 months after stroke

• Change of the Montreal Cognitive Assessment (MoCA)

  three, six and 12 months after stroke

Other Outcomes (3)

• Change in the Fatigue Severity Scale

  three, six and 12 months after stroke

• Change in the Brief Pain Inventory

  three, six and 12 months after stroke

• Change in the Multi-dimensional Scale of Perceived Social Support

  three, six and 12 months after stroke

Study Arms (3)

Validation study

Three hundred patients with ischemic stroke (18-65 years) 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.

Prospective quantitative study

Two hundred 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-depth interview qualitative 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

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Acute ischemic stroke
• Age 18-65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Elena Gurkova: lead
• University Hospital Olomouc: collaborator

Study Sites (1)

Palacky University, Faculty of Health Sciences

Olomouc, 77515, Czechia

RECRUITING

Related Publications (22)

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• 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.

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  PMID: 27176617 RESULT

• 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 RESULT

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  PMID: 25128182 RESULT

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  PMID: 32735024 RESULT

• Kapoor A, Scott C, Lanctot KL, Herrmann N, Murray BJ, Thorpe KE, Lien K, Sicard M, Swartz RH. Symptoms of depression and cognitive impairment in young adults after stroke/transient ischemic attack. Psychiatry Res. 2019 Sep;279:361-363. doi: 10.1016/j.psychres.2019.06.022. Epub 2019 Jul 1.

  PMID: 31272664 RESULT

• Kono Y, Terasawa Y, Sakai K, Iguchi Y, Nishiyama Y, Nito C, Suda S, Kimura K, Kanzawa T, Imafuku I, Nakayama T, Ueda M, Iwanaga T, Kono T, Yamashiro K, Tanaka R, Okubo S, Nakajima M, Nakajima N, Mishina M, Yaguchi H, Oka H, Suzuki M, Osaki M, Kaneko N, Kitagawa K, Okamoto S, Nomura K, Yamazaki M, Nagao T, Murakami Y. Risk factors, etiology, and outcome of ischemic stroke in young adults: A Japanese multicenter prospective study. J Neurol Sci. 2020 Oct 15;417:117068. doi: 10.1016/j.jns.2020.117068. Epub 2020 Jul 29.

  PMID: 32745720 RESULT

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  PMID: 31678939 RESULT

• Maaijwee NA, Arntz RM, Rutten-Jacobs LC, Schaapsmeerders P, Schoonderwaldt HC, van Dijk EJ, de Leeuw FE. Post-stroke fatigue and its association with poor functional outcome after stroke in young adults. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1120-6. doi: 10.1136/jnnp-2014-308784. Epub 2014 Oct 31.

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• Rhudy LM, Wells-Pittman J, Flemming KD. Psychosocial Sequelae of Stroke in Working-Age Adults: A Pilot Study. J Neurosci Nurs. 2020 Aug;52(4):192-199. doi: 10.1097/JNN.0000000000000523.

  PMID: 32511173 RESULT

• Schneider S, Taba N, Saapar M, Vibo R, Korv J. Determinants of Long-Term Health-Related Quality of Life in Young Ischemic Stroke Patients. J Stroke Cerebrovasc Dis. 2021 Feb;30(2):105499. doi: 10.1016/j.jstrokecerebrovasdis.2020.105499. Epub 2020 Nov 30.

  PMID: 33271487 RESULT

• Synhaeve NE, Arntz RM, Maaijwee NA, Rutten-Jacobs LC, Schoonderwaldt HC, Dorresteijn LD, de Kort PL, van Dijk EJ, de Leeuw FE. Poor long-term functional outcome after stroke among adults aged 18 to 50 years: Follow-Up of Transient Ischemic Attack and Stroke Patients and Unelucidated Risk Factor Evaluation (FUTURE) study. Stroke. 2014 Apr;45(4):1157-60. doi: 10.1161/STROKEAHA.113.004411. Epub 2014 Feb 27.

  PMID: 24578210 RESULT

• Rutten-Jacobs LC, Maaijwee NA, Arntz RM, Van Alebeek ME, Schaapsmeerders P, Schoonderwaldt HC, Dorresteijn LD, Overeem S, Drost G, Janssen MC, van Heerde WL, Kessels RP, Zwiers MP, Norris DG, van der Vlugt MJ, van Dijk EJ, de Leeuw FE. Risk factors and prognosis of young stroke. The FUTURE study: a prospective cohort study. Study rationale and protocol. BMC Neurol. 2011 Sep 20;11:109. doi: 10.1186/1471-2377-11-109.

  PMID: 21933424 RESULT

• Zawawi NSM, Aziz NA, Fisher R, Ahmad K, Walker MF. The Unmet Needs of Stroke Survivors and Stroke Caregivers: A Systematic Narrative Review. J Stroke Cerebrovasc Dis. 2020 Aug;29(8):104875. doi: 10.1016/j.jstrokecerebrovasdis.2020.104875. Epub 2020 May 23.

  PMID: 32689648 RESULT

• Sanakova S, Gurkova E, Bartonickova D, Sturekova L, Franc D, Zapletalova J, Divisova P, Sanak D. Post-Stroke Fatigue in Patients at 3 Months After Ischemic Stroke: Analysis From the FRAILTY Study. SAGE Open Nurs. 2025 Nov 26;11:23779608251400226. doi: 10.1177/23779608251400226. eCollection 2025 Jan-Dec.

  PMID: 41321434 DERIVED

• Sanakova S, Gurkova E, Sturekova L, Bartonickova D, Machalkova L, Mazalova L. How to return? experiences of patients in working age after first Ischaemic stroke: an interpretative phenomenological analysis of patient s perspective at 12 - 24 months post-stroke. Int J Qual Stud Health Well-being. 2024 Dec;19(1):2398249. doi: 10.1080/17482631.2024.2398249. Epub 2024 Sep 4.

  PMID: 39229807 DERIVED

• Sanak D, Gurkova E, Sturekova L, Sanakova S, Zapletalova J, Franc D, Bartonickova D. Quality of Life in Patients with Excellent 3-Month Clinical Outcome after First-Ever Ischemic Stroke: A Time to Redefine Excellent Outcome? Eur Neurol. 2024;87(1):1-10. doi: 10.1159/000535685. Epub 2024 Jan 17.

  PMID: 38232714 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elena Gurkova, PhD

  Palacky University, Faculty of Health Sciences, Department of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Gurkova, PhD

CONTACT

+420585632825; elena.gurkova@upol.cz

Daniel Sanak, MD, PhD

CONTACT

+420588442836; daniel.sanak@fnol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CZ (1)