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临床试验/NCT02793934
NCT02793934Unknown不适用

The Development Of MEdical Rehabilitation inRussia Pilot Project

St. Petersburg State Pavlov Medical University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

  1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
  2. Acute myocardial infarction (AMI, specialty cardiology)
  3. Patients after total hip replacement (THR, specialty orthopaedia) The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).

详细描述

The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).

The basic goals of the Programme are:

  1. To develop the system of organizations for medical rehabilitation providing succession of rehabilitation care in Russia with covering all needs.
  2. To improve the accessibility for rehabilitation care by the system of successive 3-stages and 3-level medical rehabilitation
  3. To develop the multidisciplinary approaches on medical rehabilitation in each stages and in medical organizations of different levels
  4. To improve patient's daily living activity, functioning, enable participation, reduce sick-leaves duration and working absenteeism, increase social role in community, prevent pain recurrence and chronicity, prevent recurrent events and hospitalizations
  5. To develop the efficacy criteria for medical rehabilitation on each stages of rehabilitation and establishing the logistic pathways for patients during rehabilitation
  6. To implement the educational programmes for personnel on PRM according to the European model.
  7. Preparation for introducing the new specialty in Russia - doctor of PRM
  8. To establish the financial methods of calculating the costs and tariffs of rehabilitation care for patients with different diseases/conditions in each stage of rehabilitation and in medical organizations of different levels
  9. To improve the financial efficacy of medical rehabilitation and substantiation for new tariff prices for rehabilitation care
  10. To demonstrate the effectiveness of the "new" model of medical rehabilitation system compared to the traditional model in the multicenter study, in patients with ACE, AMI and THR.
  11. To evaluate the clinical efficacy of the "new" model of medical rehabilitation compared to the "old" model in patients with ACE, AMI and THR by following indicators:

in-hospital and 3-months mortality , the number of complications, length of hospital stay, the degree of recovery of functions, activities and participation. To calculate the economic advantage of the "new" model of medical rehabilitation in patients with ACE, AMI and THR by the calculation of the financial cost of one case of and of the complete course of rehabilitation To study characteristics of disorders of functioning and participation. To develop the methodological framework for the establishment of a register of patients receiving rehabilitation in Russia. 12. To develop basics for establishing a quality assessment system of rehabilitative care in the Russian Federation.

The differences between the new and the old model of rehabilitation are:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age over 18 years old
  • Ischemic stroke or intracerebral hemorrhage
  • Patients with acute myocardial infarction with elevation of segment ST (STMI)
  • Total hip replacement caused by degenerative processes

排除标准

  • uncorrected metabolic diseases (diabetes mellitus, myxoedema, thyrotoxicosis);
  • III hepatic or pancreatic insufficiency
  • heavy or repeated hemorrhages of any reason or anaemia Hb<80g/l;
  • parasitoses;
  • acute infectious disease;
  • active stage of any form of tuberculosis;
  • patients with transmissible sexual diseases;
  • mental illness with personality desocialisation;
  • complicate ventricular rhythm disturbances
  • high risk of thromboembolism
  • absence of motivation
  • decompensation of somatic functions

结局指标

主要结局

Mortality

时间窗: through study completion, an average of 1 month

Recovery of functions, activity and participation

时间窗: through study completion, an average of 1 month

modified Renkin scale)

次要结局

  • Mortality(90 days after discharge)
  • Duration of hospitalization(through study completion, an average of 1 month)
  • Duration of rehabilitation process for the achievement the goals for each stage of rehabilitation(through study completion, an average of 1 month)
  • Recovery of functions, activity and participation(90 days after discharge)
  • Environmental adaptation(90 days after discharge)
  • Preventable conditions(90 days after discharge)
  • Time of start of rehabilitation(through study completion, an average of 1 month)
  • Time of the first, interim and final expert assessment of rehabilitation potential(through study completion, an average of 1 month)
  • Duration of rehabilitation process from onset of disease to final or to transfer the patient or to establishing the disability(through study completion, an average of 1 month)

研究者

发起方
St. Petersburg State Pavlov Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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