Evaluation of Life Quality in Post Stroke Patients

NCT05501275 | Completed

• 1 other identifier: PalackyU
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Quality of Life

Keywords

stroke; life quality; evaluation

Outcome Measures

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.

  3 months

Secondary Outcomes (1)

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

  before the intervence and after 3 months

Study Arms (2)

With Psychoeducation

EXPERIMENTAL

interventional group will receive psychoeducation.

Behavioral: psychotherapy

Basic Therapy Only

NO INTERVENTION

this group will receive only basic therapy

Interventions

psychotherapy BEHAVIORAL

Psychotherapy and psychoeducation in patients after stroke.

With Psychoeducation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palacky University: lead

Study Sites (1)

Palacky University

Olomouc, 77900, Czechia

Location

Related Publications (6)

• 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.

  PMID: 28594643 BACKGROUND

• 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.

  PMID: 29609550 RESULT

• 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.

  PMID: 33242261 RESULT

• 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.

  PMID: 23594060 RESULT

• 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.

  PMID: 28720980 RESULT

• 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.

  PMID: 33369683 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• David Skoloudik, Prof

  Faculty of Medicine, University of Ostrava, Syllabova 19, 703 00 Ostrava 3, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 15, 2022
• Study Start: September 14, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)