Evaluation of Life Quality in Post Stroke Patients

Palacky University (Other)
Overall Status
Enrolling by invitation
CT.gov ID

Study Details

Study Description

Brief Summary

Despite numerous advances in diagnosing procedures, treatment and prevention, stroke is considered a significant cause of long-term disability in the adult population Quality of life, which is deteriorated in patients after stroke (CVA), especially in the first years after stroke, is not only affected by the disease but is closely related to dignity and the satisfaction of human needs, including educational needs.

The term "Health-Related Quality of Life" (HRQoL) is used in the scientific literature as a criterion of change for medical purposes. It is an indicator of health service needs and a way to evaluate health status in a very efficient way. Psychoeducation can be applied in medical and nursing practice, as an intervention that can improve and/or maintain the quality of life, especially if it is provided to patients without a significant cognitive deficit. Psychoeducational programmes can be defined as didactic-therapeutic interventions that serve to provide information about the disease, emotional and social support and, last but not least, facilitate adaptation to new life situations.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: psychotherapy

Detailed Description

Detailed description:

The influence of selected aspects on HRQoL will be statistically assessed in the initial phase of the research. At a later stage, the monitored file will be randomized, in a predefined 1:1 ratio.

The control group will be provided only with conventional treatment focused on neurorehabilitation care according to the workplace's habits, and structured psychoeducation will be added to this usual care. The group psychoeducational interview, which reflects the issue of CVA, will be conducted face-to-face by a clinical psychologist, a health and social worker and a nurse. It will be limited by a 6-week therapy session 1 time per week, lasting approximately 45 minutes.

Patients will be tested with 6 standardized questionnaires in the Czech language version initially before the start of treatment and subsequently one month post the completion date of their treatment. The EuroQol-5 (EQ-5D-5L) instrument will be used to assess HRQoL. The Patient Dignity Inventory (PDI) questionnaire has been chosen to identify problems related to problems associated with patient dignity. The Mini-Mental State Examination (MMSE) cognitive test will be used to indicatively detect dementia and the Beck Depression Inventory Second Edition (BDI-II) will be used to diagnose the severity of depressive symptoms. The Visual Analogue Scale (VAS) will be used to objectify the perception of pain and the Barthel Index (BI) for scoring ADL. At the same time, selected relevant clinical and anamnestic data will be extracted from the medical records.

Study Design

Study Type:
Anticipated Enrollment :
500 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Life Quality in Post Stroke Patients
Actual Study Start Date :
Sep 14, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional

interventional group will receive psychoeducation.

Behavioral: psychotherapy
Psychotherapy and psychoeducation in patients after stroke.

No Intervention: Non-Interventional

this group will receive only basic therapy

Outcome Measures

Primary Outcome Measures

  1. Change in the Health-Related Quality of Life (HRQoL) in patients after stroke [3 months]

    Change in the Health-Related Quality of Life (HRQoL) [Time Frame: Baseline state (immediately prior to the rehabilitation facility admission) and follow-up monitoring (two and a half months after the rehabilitation facility admission)]. Health-Related Quality of Life (HRQoL) is assessed using the European Quality of Life Questionnaire version 5, level 5 instrument. Subjects are asked to assess their mobility, self-care, ADLs, pain/difficulties and anxiety/depression in 5 dimensions. Each item is scored on a 5-point scale i.e. without problems, mild problems, moderate problems, severe problems and extreme problems. The output is an index (HRQoL dimension). Subsequently, the respondents are asked to indicate their subjectively perceived health condition on a visual analogue scale forming part of the instrument.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • adult with a clinical diagnosis of CVA in his/her medical history, lasting at ≥ 6 months and ≤ 3 years since the primo-attack,

  • first hospitalized in a specialized medical institution,

  • partial self-sufficiency,

  • signed informed consent.

Exclusion Criteria:
  • non-cooperation,

  • recurrent CVA,

  • severe depression with BDI-II score ≥ 40,

  • dementia with MMSE score ≤ 25,

  • presence of cancer and/or the end-stage of the disease.

Contacts and Locations


Site City State Country Postal Code
1 Palacky University Olomouc Czechia 77900

Sponsors and Collaborators

  • Palacky University


  • Principal Investigator: David Skoloudik, Prof, Faculty of Medicine, University of Ostrava, Syllabova 19, 703 00 Ostrava 3, Czech Republic

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Eva Prusova, Principal Investigator, Palacky University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • PalackyU
First Posted:
Aug 15, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Eva Prusova, Principal Investigator, Palacky University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022