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| Name | Class |
|---|---|
| Albertinen Krankenhaus | OTHER |
| Elbe Kliniken Stade-Buxtehude GmbH | UNKNOWN |
| Reha Centrum Hamburg GmbH | UNKNOWN |
| Klinikum Bad Bramstedt GmbH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StroCare treatment group | Experimental | Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation |
|
| control group | No Intervention | routine aftercare stroke treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported physical QoL: PROMIS-10 | 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. | 1 year after index ischemic event |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported mental QoL | 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. | 1 year after index ischemic event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Götz Thomalla, Prof. Dr. | University Medical Centre Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39844272 | Derived | Schrage T, Glissmann C, Thomalla G, Rimmele DL, Schmidt H, Rosenkranz M, Boskamp S, Harter M, Kriston L. Process evaluation of a cross-sectoral, coordinated follow-up care of stroke patients: a qualitative study. Neurol Res Pract. 2025 Jan 23;7(1):4. doi: 10.1186/s42466-024-00360-1. | |
| 33526148 | Derived | Rimmele DL, Schrage T, Brettschneider C, Engels A, Gerloff C, Harter M, Rosenkranz M, Schmidt H, Kriston L, Thomalla G. Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare). Neurol Res Pract. 2021 Feb 2;3(1):7. doi: 10.1186/s42466-021-00107-2. |
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| UNKNOWN |
| MediClin Klinikum Soltau GmbH | UNKNOWN |
| VAMED Klinik Geesthacht | UNKNOWN |
| VAMED Rehaklinik Damp | UNKNOWN |
| BARMER Krankenkasse | UNKNOWN |
| Lohmann und Birkner medizinisches ServiceCenter GmbH | UNKNOWN |
| Forcare GmbH | OTHER |
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).
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|
| Patient-reported mental health status |
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 |
| 1 year after index ischemic event |
| Functional Status modified Rankin Scale questionnaire (smRSq) | Functional Status measured with the modified Rankin Scale (mRS); the nRS ranges from 0 (no disability) to 6 (death) | 1 year after index ischemic event |
| Overall survival | Overall survival measured with the ICHOM Standard set | 1 year after index ischemic event |
| Stroke recurrence | Stroke recurrence measured with the ICHOM Standard set | 1 year after index ischemic event |
| Utilisation of health care Services | 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 | 1 year after index ischemic event |
| Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment) | Waiting time extracted from the medical record and the electronic Portal (only Intervention Group) | 1 year after index ischemic event |
| Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure | 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 | 1 year after index ischemic event |
| Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol | 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 | 1 year after index ischemic event |
| Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c | 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 | 1 year after index ischemic event |
| Costs | Routine data | 1 year after index ischemic event |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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