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Completed

NCT Number: NCT04159324

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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 physical 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

Other

the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions

Primary outcomes

  1. Patient-reported physical QoL: PROMIS-10

    Time frame: 1 year after index ischemic event

    Patient-reported physical Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Physcial Health with scores ranging from 0-20 and higher scores indicating better health state.

Secondary outcomes

  1. Patient-reported mental QoL

    Time frame: 1 year after index ischemic event

    Patient-reported mental Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Mental Health with scores ranging from 0-20 and higher scores indicating better health state.

  2. 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

  3. 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)

  4. Overall survival

    Time frame: 1 year after index ischemic event

    Overall survival measured with the ICHOM Standard set

  5. Stroke recurrence

    Time frame: 1 year after index ischemic event

    Stroke recurrence measured with the ICHOM Standard set

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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

  11. Costs

    Time frame: 1 year after index ischemic event

    Routine data

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Albertinen Krankenhaus
  • BARMER Krankenkasse
  • Elbe Kliniken Stade-Buxtehude GmbH
  • Forcare GmbH
  • Klinikum Bad Bramstedt GmbH
  • Lohmann und Birkner medizinisches ServiceCenter GmbH
  • MediClin Klinikum Soltau GmbH
  • Reha Centrum Hamburg GmbH
  • VAMED Klinik Geesthacht
  • VAMED Rehaklinik Damp

Registry information

Official study title

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

Acronym: StroCare

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2019
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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