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临床试验/NCT04159324
NCT04159324已完成不适用

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

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
409
试验地点
2
主要终点
Patient-reported physical QoL: PROMIS-10

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Patient-reported physical QoL: PROMIS-10

时间窗: 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.

次要结局

  • Patient-reported mental QoL(1 year after index ischemic event)
  • Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment)(1 year after index ischemic event)
  • Functional Status modified Rankin Scale questionnaire (smRSq)(1 year after index ischemic event)
  • Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure(1 year after index ischemic event)
  • Utilisation of health care Services(1 year after index ischemic event)
  • Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol(1 year after index ischemic event)
  • Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c(1 year after index ischemic event)
  • Costs(1 year after index ischemic event)
  • Stroke recurrence(1 year after index ischemic event)
  • Patient-reported mental health status(1 year after index ischemic event)
  • Overall survival(1 year after index ischemic event)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Götz Thomalla, MD

Prof. Dr

Universitätsklinikum Hamburg-Eppendorf

研究点 (2)

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