<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03795948</url>
  </required_header>
  <id_info>
    <org_study_id>0977_114</org_study_id>
    <nct_id>NCT03795948</nct_id>
  </id_info>
  <brief_title>Patient Reported Outcomes in Stroke Care</brief_title>
  <acronym>EPOS</acronym>
  <official_title>Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The presented study is an explorative prospective study. First, it focusses on the&#xD;
      longitudinal analysis of outcome quality in stroke treatment (12 months). Particularly, it&#xD;
      addresses patient reported quality of life after inpatient stroke treatment and influencing&#xD;
      factors. Second, it focusses on the feasibility and acceptance of a standard set of measures&#xD;
      capturing outcome quality of medical care in stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With a shift in focus to patient-centered health care and a constant effort to improve the&#xD;
      quality of treatment, the role of the patient's perception of his/her medical care becomes&#xD;
      essential. Patient reported outcome measures (PROMs) are among the most adequate instruments&#xD;
      for assessing the patient's perspective on symptom load, functional status, and quality of&#xD;
      life. After stroke, patients not only suffer from objectively scaled and measurable symptoms&#xD;
      and impairments but also experience dramatic changes in everyday routine and quality of life.&#xD;
&#xD;
      In this project, a standardized outcome measurement, including PROMs, for stroke patients is&#xD;
      used.&#xD;
&#xD;
      This stoke standard set was developed by the International Consortium for Health Outcomes&#xD;
      Measurement (ICHOM; www.ICHOM.org); an international, interdisciplinary and&#xD;
      inter-professional expert group with the contribution of patient representatives, aiming to&#xD;
      create a comprehensive tool for measuring the most important outcomes and risk factors&#xD;
      applicable to a broad variety of diseases.&#xD;
&#xD;
      Main objective of this study is the analysis of quality of life 90 and 360 days after stroke&#xD;
      and its association with stroke specific risk factors and complications, also measured within&#xD;
      the scope of the ICHOM tool.&#xD;
&#xD;
      Furthermore, the process and success of the implementation of the ICHOM stroke standard set&#xD;
      within the stroke unit of the University Medical Centre Hamburg- Eppendorf (UKE) will be&#xD;
      studied and evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global patient reported health-related quality of life</measure>
    <time_frame>90 days</time_frame>
    <description>PROMIS-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported mental health status</measure>
    <time_frame>90 days</time_frame>
    <description>PHQ-4 (depression, anxiety)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of disease</measure>
    <time_frame>90 days</time_frame>
    <description>patient-reported measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute complications of treatment</measure>
    <time_frame>at discharge from inpatient care, on average 6 days after admission</time_frame>
    <description>clinical assessment of symptomatic intracranial hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of healthcare services after stroke</measure>
    <time_frame>90 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care</measure>
    <time_frame>after study completion (2 years)</time_frame>
    <description>Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychometric evaluation of the patient-reported outcome measures</measure>
    <time_frame>after study completion (2 years)</time_frame>
    <description>Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care</measure>
    <time_frame>after study completion (2 years)</time_frame>
    <description>qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">975</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>PROM Evaluation for stroke patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient will be enrolled and PROMs will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMs</intervention_name>
    <description>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.&#xD;
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.&#xD;
Telephone assessments will be administered to support patients if necessary and validate their responses.</description>
    <arm_group_label>PROM Evaluation for stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in inpatient care in the stroke unit of the UKE with the following diagnoses&#xD;
             (ICD-10):&#xD;
&#xD;
               -  Ischemic attack (I63),&#xD;
&#xD;
               -  Transient ischemic attack (G45)&#xD;
&#xD;
               -  Intracerebral hemorrhage (I64)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substantially impaired communication capacity due to aphasia or dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomalla Götz, MD, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 8, 2020</last_update_submitted>
  <last_update_submitted_qc>April 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stoke</keyword>
  <keyword>Patient-reported outcomes (PROs)</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Morbidity</keyword>
  <keyword>Mortality</keyword>
  <keyword>Functional status</keyword>
  <keyword>Patient-centered care</keyword>
  <keyword>ICHOM</keyword>
  <keyword>Treatment quality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03795948
org study id: 0977_114
nct id: NCT03795948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Global patient reported health-related quality of life
time frame: 90 days
description: PROMIS-10
measure: Patient reported mental health status
time frame: 90 days
description: PHQ-4 (depression, anxiety)
measure: Recurrence of disease
time frame: 90 days
description: patient-reported measures
measure: Acute complications of treatment
time frame: at discharge from inpatient care, on average 6 days after admission
description: clinical assessment of symptomatic intracranial hemorrhage
measure: Use of healthcare services after stroke
time frame: 90 days
description: 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.
measure: Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
time frame: after study completion (2 years)
description: Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate)
measure: Psychometric evaluation of the patient-reported outcome measures
time frame: after study completion (2 years)
description: Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population
measure: Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
time frame: after study completion (2 years)
description: qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention
arm group label: PROM Evaluation for stroke patients
arm group type: Other
description: Patient will be enrolled and PROMs will be collected.
intervention type: Other
intervention name: PROMs
description: 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.
arm group label: PROM Evaluation for stroke patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomalla Götz, MD, Prof.
role: Principal Investigator
affiliation: Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided