Stroke Clinical Trial
— StroCareOfficial title:
StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Verified date | December 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 409 |
Est. completion date | December 5, 2023 |
Est. primary completion date | December 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Albertinen Krankenhaus gGmbH, 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 |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Overall survival | Overall survival measured with the ICHOM Standard set | 1 year after index ischemic event | |
Secondary | Stroke recurrence | Stroke recurrence measured with the ICHOM Standard set | 1 year after index ischemic event | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Costs | Routine data | 1 year after index ischemic event |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|