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临床试验/NCT03038685
NCT03038685已完成不适用

A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.

University Hospital, Antwerp4 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
4
主要终点
cardiovascular risk factor control

研究概览

简要总结

The Belgian Stroke Council initiated a project to improve risk factor control and medication adherence in ischemic stroke patients by developing an individualized in-hospital initiated and post- discharge, digital coaching program addition to standard practice (strokecoach.be).

详细描述

The overall aim of this project is to further improve subacute and chronic stroke care in the Belgian context with main focus on the patients' quality of life, stroke recurrence and secondary cardiovascular prevention. Main focuses are on patient-empowerment, shared-decision making and health literacy, as these items are linked with better therapeutic adherence and self-care for chronic diseases.

In case of a positive result, implementation of this individualized chronic stroke care program executed by a personal stroke coach, initiated during hospitalization and using a web-based intervention program, can easily be unrolled in other Belgian stroke units. The program can be cost-effective if better clinical outcome, stroke recurrence rates, number of in-hospital consultations, number of rehospitalisations are reduced. This will be evaluated in a in-depth healt-economic analysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
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
否

入选标准

  • •Patients with an acute ischemic stroke hospitalized at a participating stroke center can be included during hospitalisation if fulfilling following three criteria: - they will return back home or be discharged to a rehabilitation center
  • •have a life expectancy of more than 6 months
  • •have experience with internet use (at least weekly checking emails) or a caregiver accepts to help with the digital platform.

排除标准

  • •Age < 18 years
  • •Patients unable or unwilling to be followed post-discharge for 6 months
  • •Patients with a major neurologic post-stroke and no caregiver participation
  • •Cognitive impairment limiting use of digital platform and no caregiver participation

研究组 & 干预措施

prospective, multicenter cohort

Experimental

A group of 175 patients will be recruited in 4 Belgian stroke centers during the six months period. All data will be collected prospectively and patients will be treated during six months period.

干预措施: Strokecoach.be - digital coaching program for stroke patients (Behavioral)

historical, single center cohort

No Intervention

A historical cohort of Sint-Janhospital (2011 - Bruges, Belgium) with prospectively collected data will be used as comparator for the experimental arm. These data were published in Vanacker P, Couvreur T, Vanhooren G. Can we improve cerebrovascular risk reduction in real-life? A single centre's experience. Cerebrovasc Dis 2011;31(suppl 2):289

结局指标

主要结局

cardiovascular risk factor control

时间窗: 6 months

The primary endpoint is the impact of the intervention on the cardiovascular risk factor control by assessing the evolution of the SCORE (Systematic COronary Risk Evaluation: High \& Low cardiovascular Risk Charts) risk pre- and postintervention. An official program to analyze these parameter will be used (AOST©, Crethsoft).

次要结局

  • Clinical outcome(6 months)
  • Therapeutic adherence(0.5-1-2-3-6 months)
  • Quality-of-life(3-6months)
  • Stroke recurrence rate(0.5-1-2-3-6 months)

研究者

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

PVanacker

neurovascular consultant

University Hospital, Antwerp

研究点 (4)

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