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Completed

NCT Number: NCT05501275

Evaluation of Life Quality in Post Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Quality of Life Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palacky University

Olomouc, 77900, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy

Behavioral

Psychotherapy and psychoeducation in patients after stroke.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Palacky University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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