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CompletedNCT05501275Updated Nov 18, 2023

Evaluation of Life Quality in Post Stroke Patients

An interventional study of psychotherapy in Stroke and Quality of Life, sponsored by Palacky University. Completed at 1 site in Czechia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Palacky University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
447
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke
  • Quality of Life

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Keywords

  • stroke
  • life quality
  • evaluation
03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 447 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Palacky University is the lead sponsor of 32 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
447 participants (actual)

Study arms

  • Experimental
    With Psychoeducation

    interventional group will receive psychoeducation.

    Behavioral: psychotherapy

  • No intervention
    Basic Therapy Only

    this group will receive only basic therapy

Interventions

  • Behavioralpsychotherapy

    Psychotherapy and psychoeducation in patients after stroke.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 3 months

Secondary outcomes

  1. Change in patient´s dignity, level of depression, functional independence and pain

    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)

    Time frame: before the intervence and after 3 months

07

Study locations

1 site
  • Palacky University
    Olomouc, 77900, Czechia
08

References and documents

Publications

  • Hamid GM, MacKenzie MA. CE: Early Intervention in Patients with Poststroke Depression. Am J Nurs. 2017 Jul;117(7):32-40. doi: 10.1097/01.NAJ.0000520919.26724.9b. PubMed 28594643 ↗
  • Mavaddat N, Sadler E, Lim L, Williams K, Warburton E, Kinmonth AL, Mant J, Burt J, McKevitt C. Perceptions of self-rated health among stroke survivors: a qualitative study in the United Kingdom. BMC Geriatr. 2018 Apr 2;18(1):81. doi: 10.1186/s12877-018-0765-8. PubMed 29609550 ↗
  • Verberne DPJ, Kroese MEAL, Staals J, Ponds RWHM, van Heugten CM. Nurse-led stroke aftercare addressing long-term psychosocial outcome: a comparison to care-as-usual. Disabil Rehabil. 2022 Jun;44(12):2849-2857. doi: 10.1080/09638288.2020.1849417. Epub 2020 Nov 26. PubMed 33242261 ↗
  • Ostwald SK, Godwin KM, Cron SG, Kelley CP, Hersch G, Davis S. Home-based psychoeducational and mailed information programs for stroke-caregiving dyads post-discharge: a randomized trial. Disabil Rehabil. 2014;36(1):55-62. doi: 10.3109/09638288.2013.777806. Epub 2013 Apr 17. PubMed 23594060 ↗
  • Olukolade O, Osinowo HO. Efficacy of Cognitive Rehabilitation Therapy on Poststroke Depression among Survivors of First Stroke Attack in Ibadan, Nigeria. Behav Neurol. 2017;2017:4058124. doi: 10.1155/2017/4058124. Epub 2017 Jun 27. PubMed 28720980 ↗
  • Brouns B, van Bodegom-Vos L, de Kloet AJ, Tamminga SJ, Volker G, Berger MAM, Fiocco M, Goossens PH, Vliet Vlieland TPM, Meesters JJL. Effect of a comprehensive eRehabilitation intervention alongside conventional stroke rehabilitation on disability and health-related quality of life: A pre-post comparison. J Rehabil Med. 2021 Mar 5;53(3):jrm00161. doi: 10.2340/16501977-2785. PubMed 33369683 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05501275
Lead sponsor
Palacky University
Responsible party
Eva Prusova (Principal Investigator, Palacky University) — Principal investigator
First posted
Aug 15, 2022
Start date
Sep 14, 2021
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Nov 18, 2023

Study contacts

David Skoloudik, Prof
principal investigator · Faculty of Medicine, University of Ostrava, Syllabova 19, 703 00 Ostrava 3, Czech Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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