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

Stroke Clinical Trial

— StroCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159324
• Other study ID #: 01NVF18022
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (11)

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

Country where clinical trial is conducted

Germany, 

Outcome

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