Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
975 participants
INTERVENTIONAL
2017-07-01
2019-12-31
Brief Summary
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Detailed Description
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In this project, a standardized outcome measurement, including PROMs, for stroke patients is used.
This stoke standard set was developed by the International Consortium for Health Outcomes Measurement (ICHOM; www.ICHOM.org); an international, interdisciplinary and inter-professional expert group with the contribution of patient representatives, aiming to create a comprehensive tool for measuring the most important outcomes and risk factors applicable to a broad variety of diseases.
Main objective of this study is the analysis of quality of life 90 and 360 days after stroke and its association with stroke specific risk factors and complications, also measured within the scope of the ICHOM tool.
Furthermore, the process and success of the implementation of the ICHOM stroke standard set within the stroke unit of the University Medical Centre Hamburg- Eppendorf (UKE) will be studied and evaluated.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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PROM Evaluation for stroke patients
Patient will be enrolled and PROMs will be collected.
PROMs
Introduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke.
Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life.
Telephone assessments will be administered to support patients if necessary and validate their responses.
Interventions
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PROMs
Introduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke.
Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life.
Telephone assessments will be administered to support patients if necessary and validate their responses.
Eligibility Criteria
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Inclusion Criteria
* Ischemic attack (I63),
* Transient ischemic attack (G45)
* Intracerebral hemorrhage (I64)
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Thomalla Götz, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
Locations
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Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, , Germany
Countries
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References
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Rimmele DL, Petersen EL, Schrage T, Harter M, Kriston L, Thomalla G. Self-reported health status of patients with acute retinal ischemia and stroke related hemianopia. Eur Stroke J. 2025 Sep;10(3):837-843. doi: 10.1177/23969873251314715. Epub 2025 Jan 25.
Lebherz L, Fraune E, Thomalla G, Frese M, Appelbohm H, Rimmele DL, Harter M, Kriston L. Implementability of collecting patient-reported outcome data in stroke unit care - a qualitative study. BMC Health Serv Res. 2022 Mar 16;22(1):346. doi: 10.1186/s12913-022-07722-y.
Rimmele DL, Schrage T, Lebherz L, Kriston L, Gerloff C, Harter M, Thomalla G. Profiles of patients' self-reported health after acute stroke. Neurol Res Pract. 2021 Aug 23;3(1):43. doi: 10.1186/s42466-021-00146-9.
Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study. Neurol Res Pract. 2019 Nov 1;1:28. doi: 10.1186/s42466-019-0034-0. eCollection 2019.
Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Health-related quality of life 90 days after stroke assessed by the International Consortium for Health Outcome Measurement standard set. Eur J Neurol. 2020 Dec;27(12):2508-2516. doi: 10.1111/ene.14479. Epub 2020 Sep 7.
Other Identifiers
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0977_114
Identifier Type: -
Identifier Source: org_study_id
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