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

NCT ID: NCT04159324

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Keywords

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Stroke Patient-reported outcomes (PROs) Cross-sectoral care Stroke aftercare Aftercare coordination Post-rehabilitation support Evidence based treatment Patient-centred care Quality of life Morbidity Mortality Functional status Feasibility Acceptance Process evaluation Health economics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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StroCare treatment group

Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

Group Type EXPERIMENTAL

optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

Intervention Type OTHER

the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions

control group

routine aftercare stroke treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albertinen Krankenhaus

OTHER

Sponsor Role collaborator

Elbe Kliniken Stade-Buxtehude GmbH

UNKNOWN

Sponsor Role collaborator

Reha Centrum Hamburg GmbH

UNKNOWN

Sponsor Role collaborator

Klinikum Bad Bramstedt GmbH

UNKNOWN

Sponsor Role collaborator

MediClin Klinikum Soltau GmbH

UNKNOWN

Sponsor Role collaborator

VAMED Klinik Geesthacht

UNKNOWN

Sponsor Role collaborator

VAMED Rehaklinik Damp

UNKNOWN

Sponsor Role collaborator

BARMER Krankenkasse

UNKNOWN

Sponsor Role collaborator

Lohmann und Birkner medizinisches ServiceCenter GmbH

UNKNOWN

Sponsor Role collaborator

Forcare GmbH

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Götz Thomalla, MD

Prof. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Götz Thomalla, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39844272 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33526148 (View on PubMed)

Other Identifiers

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01NVF18022

Identifier Type: -

Identifier Source: org_study_id