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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

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.

Condition or disease Intervention/treatment Phase
Stroke Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
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
Official Title: StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: StroCare treatment group
Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
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

No Intervention: control group
routine aftercare stroke treatment



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Overall survival [ Time Frame: 1 year after index ischemic event ]
    Overall survival measured with the ICHOM Standard set

  4. Stroke recurrence [ Time Frame: 1 year after index ischemic event ]
    Stroke recurrence measured with the ICHOM Standard set

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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

  10. Costs [ Time Frame: 1 year after index ischemic event ]
    Routine data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159324


Contacts
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Contact: Götz Thomalla, Prof. Dr. +4940741050137 thomalla@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Goetz Thomalla, MD       wakeup@uke.de   
Contact: Christian Gerloff, MD       wakeup@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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
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Principal Investigator: Götz Thomalla, Prof. Dr. University Medical Centre Hamburg-Eppendorf
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Responsible Party: Götz Thomalla, MD, Prof. Dr, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04159324    
Other Study ID Numbers: 01NVF18022
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf:
Stroke
Patient-reported outcomes (PROs)
Cross-sectoral care
Stroke aftercare
Aftercare coordination
Post-rehabilitation support
Evidence based treatment
Patient-centred care
Quality of life
Morbidity
Mortality
Functional status
Feasibility
Acceptance
Process evaluation
Health economics
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases