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Evaluation of Life Quality in Post Stroke Patients

Primary Purpose

Stroke, Quality of Life

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
psychotherapy
Sponsored by
Palacky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring stroke, life quality, evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Palacky University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

With Psychoeducation

Basic Therapy Only

Arm Description

interventional group will receive psychoeducation.

this group will receive only basic therapy

Outcomes

Primary Outcome Measures

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. 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.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2022
Last Updated
September 22, 2022
Sponsor
Palacky University
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1. Study Identification

Unique Protocol Identification Number
NCT05501275
Brief Title
Evaluation of Life Quality in Post Stroke Patients
Official Title
Evaluation of Life Quality in Post Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palacky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Quality of Life
Keywords
stroke, life quality, evaluation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With Psychoeducation
Arm Type
Experimental
Arm Description
interventional group will receive psychoeducation.
Arm Title
Basic Therapy Only
Arm Type
No Intervention
Arm Description
this group will receive only basic therapy
Intervention Type
Behavioral
Intervention Name(s)
psychotherapy
Intervention Description
Psychotherapy and psychoeducation in patients after stroke.
Primary Outcome Measure Information:
Title
Change in the Health-Related Quality of Life (HRQoL) in patients after stroke
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Skoloudik, Prof
Organizational Affiliation
Faculty of Medicine, University of Ostrava, Syllabova 19, 703 00 Ostrava 3, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palacky University
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28594643
Citation
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.
Results Reference
background
PubMed Identifier
29609550
Citation
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.
Results Reference
result
PubMed Identifier
33242261
Citation
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.
Results Reference
result
PubMed Identifier
23594060
Citation
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.
Results Reference
result
PubMed Identifier
28720980
Citation
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.
Results Reference
result
PubMed Identifier
33369683
Citation
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.
Results Reference
result

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Evaluation of Life Quality in Post Stroke Patients

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