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StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement (StroCare)

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ClinicalTrials.gov Identifier: NCT04159324
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
Albertinen Krankenhaus gGmbH
Elbe Kliniken Stade-Buxtehude GmbH
Reha Centrum Hamburg GmbH
Klinikum Bad Bramstedt GmbH
MediClin Klinikum Soltau GmbH
VAMED Klinik Geesthacht
VAMED Rehaklinik Damp
BARMER Krankenkasse
Lohmann und Birkner medizinisches ServiceCenter GmbH
Forcare GmbH
Information provided by (Responsible Party):
Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
Patient-reported QoL: PROMIS-10 [ Time Frame: 1 year after index ischemic event ]
Patient-reported Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); this provides two global scores: Global Physical Health and Global Mental Health with scores ranging from 0-20 each and higher scores indicating better health state.
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
Patient-reported QoL: PROMIS-10 [ Time Frame: 1 year after index ischemic event ]
Patient-reported QoL measured with PROMIS-10
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • Patient-reported mental health status [ Time Frame: 1 year after index ischemic event ]
    Patient reported mental health Status measured with the Patient health questionnaire (PHQ-4); the questionnaire provides two sub-scores measuring anxiety and depression with scores ranging from 0-6 each with higher scores indiciating more symptoms of anxiety or depression, respectively
  • Functional Status modified Rankin Scale questionnaire (smRSq) [ Time Frame: 1 year after index ischemic event ]
    Functional Status measured with the modified Rankin Scale (mRS); the nRS ranges from 0 (no disability) to 6 (death)
  • Overall survival [ Time Frame: 1 year after index ischemic event ]
    Overall survival measured with the ICHOM Standard set
  • Stroke recurrence [ Time Frame: 1 year after index ischemic event ]
    Stroke recurrence measured with the ICHOM Standard set
  • Utilisation of health care Services [ Time Frame: 1 year after index ischemic event ]
    Utilisation of health care Services extracted from the medical record and the electronic Portal (only Intervention Group), i.e., number of admissions to hospital, number of outpatient contacts, weekly hours of physiotherapy, speech therapy, occupational therapy
  • Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment) [ Time Frame: 1 year after index ischemic event ]
    Waiting time extracted from the medical record and the electronic Portal (only Intervention Group)
  • Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure [ Time Frame: 1 year after index ischemic event ]
    Current values Blood Pressure will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation
  • Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol [ Time Frame: 1 year after index ischemic event ]
    Current values of LDL-cholesterol will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation
  • Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c [ Time Frame: 1 year after index ischemic event ]
    Current values of HbA1c will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation
  • Costs [ Time Frame: 1 year after index ischemic event ]
    Routine data
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Patient-reported mental health status [ Time Frame: 1 year after index ischemic event ]
    Patient reported mental health Status measured with the Patient health questionnaire (PHQ-4)
  • Functional Status modified Rankin Scale questionnaire (smRSq) and Patient-reported measures [ Time Frame: 1 year after index ischemic event ]
    Functional Status measured with the modified Rankin Scale (mRS)
  • Overall survival [ Time Frame: 1 year after index ischemic event ]
    Overall survival measured with the ICHOM Standard set
  • Stroke recurrence [ Time Frame: 1 year after index ischemic event ]
    Stroke recurrence measured with the ICHOM Standard set
  • Utilisation of health care Services [ Time Frame: 1 year after index ischemic event ]
    Utilisation of health care Services extracted from the medical record and the electronic Portal (only Intervention Group )
  • Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment) [ Time Frame: 1 year after index ischemic event ]
    Waiting time extracted from the medical record and the electronic Portal (only Intervention Group)
  • Target values of relevant risk factors (according to the S3 Guideline) [ Time Frame: 1 year after index ischemic event ]
    Target values of relevant risk factors extracted from the medical record and the electronic portal
  • Costs [ Time Frame: 1 year after index ischemic event ]
    Routine data
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Official Title  ICMJE StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Brief Summary The Trial is a multi-centred controlled interventional study with a pre-post design. The primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the StroCare treatment.
Detailed Description Stroke is the second most common cause of death in Germany and the most common cause for life-long disability in adulthood. After stroke, patients often experience incisive changes in their health, daily routine and quality of life. The developed model of care (StroCare treatment) forms a cross--sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation. It aims to optimize the transition from acute inpatient treatment after an acute stroke to the ambulant neurological rehabilitation treatment. This is done firstly by creating an electronic portal solution for a safe and coordinated transmission of clinical data between the three participating hospitals and five stroke-specialized ambulant rehabilitation clinics and secondly by introducing a case-manager provided by the participating health insurance agency for patient support and aftercare coordination. The presented study is a multi-centred controlled interventional study with a pre-post design. Stroke patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), and routine data provided by the collaborating BARMER health insurance agency (for the Intervention and control group and additionally for a historic control). The main hypotheses are : (1) The StroCare treatment is more effective than the routine aftercare treatment (primary outcome: patient-reported quality of life) and (2) the StroCare treatment reduces costs for care and in the inpatient sector by providing more coordinated and thorough rehabilitation and outpatient aftercare.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
For a 12-months period patients undergoing aftercare treatment as usual are enrolled as an active control group. Subsequently, the intervention is implemented (StroCare treatment) and enrolment of the intervention group takes place for another 12 months. Patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), routine data provided by the collaborating BARMER health insurance agency (for the intervention and control group and additionally for a historic control).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Stroke
Intervention  ICMJE Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions
Study Arms  ICMJE
  • Experimental: StroCare treatment group
    Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
    Intervention: Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
  • No Intervention: control group
    routine aftercare stroke treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2019)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients in inpatient care in the stroke unit of one of the participating acute clinics who are insured at the BARMER health insurance agency with the following diagnosis (ICD-10):
  • Ischemic attack (I63)
  • Transient ischemic attack and related syndromes (G45)
  • Intracerebral haermorrhage (I64)
  • Written informed consent
  • Sufficient mastery of German language

Exclusion Criteria:

  • Substantially impaired communication capacity due to aphasia or dementia
  • Patients with artificial Respiration
  • Insufficient adherence
  • Premorbid score of mRS≥4
  • Patients with artificial Respiration (Z99.1)
  • Dementia (F00.x., F01.x. or G30.x) or aphasia (R47)
  • Death during inpatient Treatment or the Admission to a nursing home following the acute treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Götz Thomalla, Prof. Dr. +4940741050137 thomalla@uke.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159324
Other Study ID Numbers  ICMJE 01NVF18022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE
  • Albertinen Krankenhaus gGmbH
  • Elbe Kliniken Stade-Buxtehude GmbH
  • Reha Centrum Hamburg GmbH
  • Klinikum Bad Bramstedt GmbH
  • MediClin Klinikum Soltau GmbH
  • VAMED Klinik Geesthacht
  • VAMED Rehaklinik Damp
  • BARMER Krankenkasse
  • Lohmann und Birkner medizinisches ServiceCenter GmbH
  • Forcare GmbH
Investigators  ICMJE
Principal Investigator: Götz Thomalla, Prof. Dr. University Medical Centre Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP