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

NCT04159324 | Completed

• 1 other identifier: 01NVF18022
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient-reported mental QoL

  1 year after index ischemic event

• Patient-reported mental health status

  1 year after index ischemic event

• Functional Status modified Rankin Scale questionnaire (smRSq)

  1 year after index ischemic event

• Overall survival

  1 year after index ischemic event

• Stroke recurrence

  1 year after index ischemic event

Study Arms (2)

StroCare treatment group

EXPERIMENTAL

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

control group

NO INTERVENTION

routine aftercare stroke treatment

Interventions

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

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

StroCare treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Albertinen Krankenhaus: collaborator
• Elbe Kliniken Stade-Buxtehude GmbH: collaborator
• Reha Centrum Hamburg GmbH: collaborator
• Klinikum Bad Bramstedt GmbH: collaborator
• MediClin Klinikum Soltau GmbH: collaborator
• VAMED Klinik Geesthacht: collaborator
• VAMED Rehaklinik Damp: collaborator
• BARMER Krankenkasse: collaborator
• Lohmann und Birkner medizinisches ServiceCenter GmbH: collaborator
• Forcare GmbH: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

• 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.

  PMID: 39844272 DERIVED

• 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.

  PMID: 33526148 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Götz Thomalla, Prof. Dr.

  University Medical Centre Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Model Details: 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).

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: January 1, 2020
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

DE (1)