An interventional study of optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation in Stroke, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Health services research
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 409 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
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Exclusion Criteria:
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
routine aftercare stroke treatment
the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions
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.
Time frame: 1 year after index ischemic event
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.
Time frame: 1 year after index ischemic event
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
Time frame: 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)
Time frame: 1 year after index ischemic event
Overall survival
Overall survival measured with the ICHOM Standard set
Time frame: 1 year after index ischemic event
Stroke recurrence
Stroke recurrence measured with the ICHOM Standard set
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year after index ischemic event
Costs
Routine data
Time frame: 1 year after index ischemic event
Plan to share: Undecided
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf