Evaluation of Life Quality in Post Stroke Patients

November 15, 2023 updated by: Eva Prusova, Palacky University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

447

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Czechia
      • Olomouc, Czechia, 77900
        • Palacky University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With Psychoeducation
interventional group will receive psychoeducation.
Behavioral: psychotherapy
Psychotherapy and psychoeducation in patients after stroke.
No Intervention: Basic Therapy Only
this group will receive only basic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Health-Related Quality of Life (HRQoL) in patients after stroke
Time Frame: 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. The output is an index (HRQoL dimension). Subsequently, the respondents are asked to indicate their subjectively perceived health condition.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient´s dignity, level of depression, functional independence and pain
Time Frame: before the intervence and after 3 months

Several scales were used:

  • to measure the patient´s dignity: Patient Dignity Inventory
  • to measure the level of depression: Beck Depression Inventory-II (BDI-II)
  • to measure the level of functional independence: Barthel Index (BI)
  • to measure the level of pain: visual analogue scale (VAS)
before the intervence and after 3 months

Collaborators and Investigators

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

Sponsor

Palacky University

Investigators

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

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)

September 14, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PalackyU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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