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临床试验/NCT03927300
NCT03927300已完成不适用

Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

Tmm Software1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年7月17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
72
试验地点
1
主要终点
Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.

研究概览

简要总结

The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).

研究设计

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

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

  • Adult patients (≥ 18 years) with no age limit;
  • Patients receiving peritoneal dialysis on the investigation center between 2012 and 2014 (Group1) and between 2016 and 2018 (Group 2);
  • Patient information in this retrospective study;

排除标准

  • Patients who have started a peritoneal dialysis program before the periods of investigation;
  • Patients who have been equipped with apTeleCare during the dialysis program;
  • Subject under guardianship, curators or safeguard of justice;
  • Patient not affiliated to a French social protection;

结局指标

主要结局

Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.

时间窗: up to two years.

Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.

时间窗: up to two years.

次要结局

  • Total length of hospitalisation(For both groups. Every two months (follow-up visit) on a retrospective period of two years, the outcome 2 will be measured. The study duration will be of 5 months)
  • Mortality rate(For both groups. At the end of this retrospective study (Study Period of 5 months).)
  • Number of patient exit technique except death(For both groups. At the end of this retrospective study. (Study Period of 5 months).)
  • Number of events of cardiovascular complications(For both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months)
  • Rate of peritoneal infections(For both groups. At the end of this retrospective study.(Study Period of 5 months).)
  • Charlson score : Comorbidity index(baseline)

研究者

发起方
Tmm Software
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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