Stroke Clinical Trial
Official title:
Evaluation of Life Quality in Post Stroke Patients
Verified date | November 2023 |
Source | Palacky University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 447 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Czechia | Palacky University | Olomouc |
Lead Sponsor | Collaborator |
---|---|
Palacky University |
Czechia,
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 hea — View 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. — View 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/s12877-018-07 — View 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. — View 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 — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
before the intervence and after 3 months |
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