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临床试验/NCT02135458
NCT02135458已完成不适用

Clinical and Medico-economic Assessment of Conventional Care Plus the "Autonom@Dom" Telemonitoring System Versus a Conventional Care Package Alone, for People With Heart Failure in Several French Structures.

University Hospital, Grenoble6 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2014年4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
发起方
入组人数
84
试验地点
6
主要终点
Hospitalization

研究概览

简要总结

Heart failure is the principle cause of hospitalisation for people over 65. the assumption is that a system of home based telemonitoring can reduce the rate of unscheduled hospitalisation or rehospitalisation for heart failure (compared to a care package alone), This randomised controlled pilot study should assess the feasibility in terms of patient inclusion and follow-up.

详细描述

Chronic diseases such as heart failure are a major burden for healthcare systems They are punctuated by exacerbations, often markers of poor prognosis, and are associated with expensive unscheduled hospitalizations. After initial diagnosis, despite the development of both drug and physical therapies, the rate of re-hospitalization for heart failure remains high with 50% or more of patients readmitted within 6 months.

Recommendations for the treatment of heart failure patients are extremely precise and justify close collaboration between local community services and the hospital. However there is often considerable divergence between recommended care and the reality, due in particular to the difficulty in monitoring ambulatory patients. For example, the dose titration of beta-blockers or ACE inhibitors need to be monitored, and dosages of diuretics need to be adapted to avoid side effects which affect the quality of life of patients and limit medication adherence etc. The establishment of 'ambulatory' care networks (including multidisciplinary health professionnals of city and hospital and therapeutic patient education) such as that in Isère County in France has demonstrated its effectiveness.

However, more advanced tools for patient monitoring still need to be assessed, particularly 'home monitoring', because there is not yet consensus as to the role tele-monitoring should play in the context of heart failure, and to date recommendations are vague. Assess the clinical and medico-economic benefit of an innovative patient monitoring strategy 'AUTONOM @ DOM' is needed.

The primary aim of this study is then to assess a system of home based telemonitoring .The main outcome is unscheduled hospitalisation for heart failure. secondary aims were to assess the efficacy of this system, quality of life and medico-economic benefit.

This pilot study is realised in the Isère and Essonne counties of France. Patients diagnosed with heart failure will be randomized to one of the following groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Age 60 years or more
  • Covered by French social security system or equivalent
  • Written informed consent signed by patient
  • Heart failure diagnosed by a cardiologue
  • NYHA stage II, III or IV
  • Able to be followed-up for 1 year
  • Attend general healthcare education sessions

排除标准

  • Freedom restricted by judicial order
  • Under legal protection
  • Require peritoneal dialysis or hemofiltration
  • Participation refused by patient, primary care physician or cardiologist
  • Present a severe comorbidity with poor short-term prognosis
  • Present asymptomatic heart failure NYHA stage I
  • Programmed surgical intervention: valve prosthesis or revascularization
  • Impossibility to follow a program of patient education
  • Residing in medicalized care facility for persons without autonomy
  • Residing outside the recruitment zones

研究组 & 干预措施

Telemonitoring

Experimental

Home-based patient management using AUTONOM@DOM telemonitoring system to record and transmit heart rate, blood pressure and weight; along side conventional care (patient therapeutic education or personalised care program)

干预措施: Telemonitoring (Other)

Telemonitoring

Experimental

Home-based patient management using AUTONOM@DOM telemonitoring system to record and transmit heart rate, blood pressure and weight; along side conventional care (patient therapeutic education or personalised care program)

干预措施: Conventional care (Other)

Conventional care

Active Comparator

Conventional care including patient therapeutic education or personalised care program

干预措施: Conventional care (Other)

结局指标

主要结局

Hospitalization

时间窗: one year

Hospitalization at any time during follow-up, emergency, unplanned, inappropriate or early (within one month) rehospitalization or not. The type and length of hospital stay will be recorded.

次要结局

  • efficacy telemonitoring system criteria(one year)
  • medicoeconomic criteria(one year)
  • Comparison of quality of life(one year)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Principal Investigator
主要研究者

AdministrateurCIC

Dr Yannick NEUDER, University Hospital, Grenoble

University Hospital, Grenoble

研究点 (6)

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