University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
NCT Number: NCT04159324
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hamburg, 20246, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions
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.
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.
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
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)
Time frame: 1 year after index ischemic event
Overall survival measured with the ICHOM Standard set
Time frame: 1 year after index ischemic event
Stroke recurrence measured with the ICHOM Standard set
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
Time frame: 1 year after index ischemic event
Waiting time extracted from the medical record and the electronic Portal (only Intervention Group)
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
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
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
Time frame: 1 year after index ischemic event
Routine data
Universitätsklinikum Hamburg-Eppendorf
Other
StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Acronym: StroCare
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.
Published trials that share one or more normalized conditions with this study.
NCT02425345
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT05589402
Bone Diseases, Brain Diseases
Harlingen, Texas, United States
View Trial DetailsNCT06750692
Brain Diseases, Cardiovascular Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT04992195
Alzheimer Disease, Arterial Thromboembolism
Hong Kong
View Trial Details