Patient Reported Outcomes in Stroke Care

NCT ID: NCT03795948

Last Updated: 2020-04-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-12-31

Brief Summary

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The presented study is an explorative prospective study. First, it focusses on the longitudinal analysis of outcome quality in stroke treatment (12 months). Particularly, it addresses patient reported quality of life after inpatient stroke treatment and influencing factors. Second, it focusses on the feasibility and acceptance of a standard set of measures capturing outcome quality of medical care in stroke patients.

Detailed Description

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With a shift in focus to patient-centered health care and a constant effort to improve the quality of treatment, the role of the patient's perception of his/her medical care becomes essential. Patient reported outcome measures (PROMs) are among the most adequate instruments for assessing the patient's perspective on symptom load, functional status, and quality of life. After stroke, patients not only suffer from objectively scaled and measurable symptoms and impairments but also experience dramatic changes in everyday routine and quality of life.

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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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PROM Evaluation for stroke patients

Patient will be enrolled and PROMs will be collected.

Group Type OTHER

PROMs

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients in inpatient care in the stroke unit of the UKE with the following diagnoses (ICD-10):

* Ischemic attack (I63),
* Transient ischemic attack (G45)
* Intracerebral hemorrhage (I64)
* Written informed consent

Exclusion Criteria

* Substantially impaired communication capacity due to aphasia or dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 39862068 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35292028 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34420516 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33324894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32810906 (View on PubMed)

Other Identifiers

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0977_114

Identifier Type: -

Identifier Source: org_study_id

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