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临床试验/NCT05649280
NCT05649280已完成不适用

Safety Evaluation of DREPADOM - Home Care Services and Hospitalizations for Sickle Cell Disease Patients

Soutien aux Actions contre les Maladies du Globule Rouge1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Incidence of acute chest pain

研究概览

简要总结

The objective of this study is to evaluate the incidence of ACS within the DREPADOM system and compare it to expected incidences of ACS (historic cohorts of PRESEV1 and PRESEV2)

详细描述

This prospective, observational study will take place, as follows:

Calculation of the PRESEV score in the ER will determine or not eligibility of the patient in the DREPADOM structure. With a low score, a patient is eligible for home monitoring and after duly provided information, can sign a patient consent for the use of personal medical data.

The coordinating nurse from DREPADOM can then set up a whole network, with the delivery of oxygen supply at the patient's house, dispatch of a medical prescription to a neighboring pharmacy and daily visits from homecare service providers. Both opioids and parenteral hydration and treatments can be prescribed and daily visits, up to three, are programmed. As such, the patient receives a minimum of 1 visit per day from a nurse for monitoring and is provided with a medical oxygen concentrator for home use (3L/min continuously or for at least 15h/day) and parenteral hydration. In addition, patients are called daily by general practitioners or SCD experts, for teleconsultations.

The DREPADOM coordinating nurse is in constant interaction with nurses/providers of homecare services/medical doctors and status and evolution of the patient's global condition is reported both through the constant contact with the coordinating nurse from DREPADOM and in a dedicated software (Link4Life), with monitoring of blood pressure, temperature, respiratory rate, pain, etc... Link4Life is a software tool developed especially for home monitoring. It is adaptable to specific disorders, fully complies with the French Law for Health Data management and allows data extraction. Link4Life has been adapted to SCD in full collaboration with SCD medical experts of the Henri Mondor hospital. It is to be noted that all medical doctors (general practitioners or SCD experts), as well as coordinating and visiting nurses have all access to this application. As such, Link4Life will gather and capture all patient data.

When reporting patients' clinical parameters daily in the dedicated app (controlled by the DREPADOM team of experts), alerts are generated in the software when these are above or below determined thresholds. The medical team of experts from DREPADOM then takes over for daily teleconsultations and medical decisions for pursuing home monitoring or hospital admittance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • SS or Sβ0
  • Adult patients with a low PRESEV score

排除标准

  • SC/Sβ+ patients
  • SCD adult patients with an intermediate or high PRESEV score
  • Pregnant or breastfeeding women
  • Homeless patient
  • Patients without Social Security
  • Patient deprived of liberty by judicial or administrative decision or patient under guardianship

结局指标

主要结局

Incidence of acute chest pain

时间窗: 30 months

The primary endpoint is the incidence of Acute chest pain complications developed by patients in the DREPADOM system ( Home Care Services and Hospitalizations for Sickle Cell Disease Patients) and comparison with the historical cohorts of( PRESEV1 and PRESEV2 studies).

次要结局

  • Incidence of clinical complications associated to Sickle cell disease(30 months)

研究者

发起方
Soutien aux Actions contre les Maladies du Globule Rouge
申办方类型
Other
责任方
Sponsor

研究点 (1)

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