StrokeEPOSNCT03795948
Patient Reported Outcomes in Stroke Care
A study testing PROMs in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- PROMs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Substantially impaired communication capacity due to aphasia or dementia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, 20246
About this study
Official title: Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS
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.
Read the detailed description
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
- Stroke
- Being tested
- PROMs
- Keywords
- Stoke, Patient-reported outcomes (PROs), Quality of life, Morbidity, Mortality, Functional status, Patient-centered care, ICHOM, Treatment quality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PROM Evaluation for stroke patients | Other | Patient will be enrolled and PROMs will be collected. Receives: Other: PROMs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global patient reported health-related quality of life
PROMIS-10
Measured: 90 days
Secondary outcomes (7)
Patient reported mental health status
PHQ-4 (depression, anxiety)
Measured: 90 days
Recurrence of disease
patient-reported measures
Measured: 90 days
Acute complications of treatment
clinical assessment of symptomatic intracranial hemorrhage
Measured: at discharge from inpatient care, on average 6 days after admission
Use of healthcare services after stroke
Patient-reported measures about the patient's level of care and use of specific rehabilitation measures as part of the ICHOM stroke standard set, specifically two questions ranging from 0 to 5 and 0 to 4 with 0 denoting self-containment and no use of rehabilitation services respec-tively and 5 and 4 denoting high level care-dependency and admission in longterm care facilities respectively.
Measured: 90 days
Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate)
Measured: after study completion (2 years)
Psychometric evaluation of the patient-reported outcome measures
Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population
Measured: after study completion (2 years)
Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention
Measured: after study completion (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Jul 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomalla Götz, MD, Prof., Principal investigator, Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795948
- Sponsor's protocol ID
- 0977_114
- Acronym
- EPOS
- Status last verified
- Apr 2020
- First submitted
- 19 Jan 2018
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39862068Lebherz 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.
PubMed 35292028Rimmele 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.
PubMed 34420516Rimmele 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.
PubMed 33324894Rimmele 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.
PubMed 32810906
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS
- ClinicalTrials.gov ID
- NCT03795948
- Acronym / sponsor ID
- EPOS / 0977_114
- Conditions
- Stroke
- Keywords
- Stoke, Patient-reported outcomes (PROs), Quality of life, Morbidity, Mortality, Functional status, Patient-centered care, ICHOM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 975 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROM Evaluation for stroke patients | Other | Other: PROMsPatient will be enrolled and PROMs will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in inpatient care in the stroke unit of the UKE with the following diagnoses (ICD-10):
- Written informed consent
Key exclusion criteria (1 listed)
- Substantially impaired communication capacity due to aphasia or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMsIntroduction 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. | Other | PROM Evaluation for stroke patients |
Primary outcome
Global patient reported health-related quality of life
Time frame: 90 days
PROMIS-10
7 secondary outcomes
Patient reported mental health status
Time frame: 90 days
Recurrence of disease
Time frame: 90 days
Acute complications of treatment
Time frame: at discharge from inpatient care, on average 6 days after admission
Use of healthcare services after stroke
Time frame: 90 days
Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
Time frame: after study completion (2 years)
Psychometric evaluation of the patient-reported outcome measures
Time frame: after study completion (2 years)
Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
Time frame: after study completion (2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Derived from this study: PubMed 39862068Rimmele 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.
- Derived from this study: PubMed 35292028Lebherz 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.
- Derived from this study: PubMed 34420516Rimmele 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.
- Derived from this study: PubMed 33324894Rimmele 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.
- Derived from this study: PubMed 32810906Rimmele 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomalla Götz, MD, Prof. principal investigator
Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMs in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global patient reported health-related quality of life (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03795948, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.