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

April 3, 2024 updated by: Elena Gurkova

Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults: a Prospective Observational Study in Young Ischemic Stroke Patients Under 50 Years

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Olomouc, Czechia, 77515
        • Recruiting
        • Palacky University, Faculty of Health Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Stroke Impact Scale (version 3.0)
Time Frame: 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
three, six and 12 months after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported)
Time Frame: 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)
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
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.
three, six and 12 months after stroke
Change of Modified Rankin Scale (self-reported)
Time Frame: 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.
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
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.
three, six and 12 months after stroke
Change of the Montreal Cognitive Assessment (MoCA)
Time Frame: 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.
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
Semi-structured interviews with stroke patients
three and 12 months after stroke
Change in the NIH Stroke Scale (NIHSS)
Time Frame: 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.
three, six and 12 months after stroke

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Fatigue Severity Scale
Time Frame: 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.
three, six and 12 months after stroke
Change in the Brief Pain Inventory
Time Frame: 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.
three, six and 12 months after stroke
Change in the Multi-dimensional Scale of Perceived Social Support
Time Frame: 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.
three, six and 12 months after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elena Gurkova

Collaborators

University Hospital Olomouc

Investigators

  • Principal Investigator: Elena Gurkova, PhD, Palacky University, Faculty of Health Sciences, Department of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU21-09-00053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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