跳至主要内容
临床试验/NCT03051724
NCT03051724已完成不适用

Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月6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
30
试验地点
2
主要终点
To evaluate the telematic CPAP follow up

研究概览

简要总结

Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. New communication technologies and the current health challenges, such as aging and high health care costs have encouraged the interest in new strategies.

As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use internet and mobile technologies usually. However, there is a significant percentage of patients that does not use Internet and mobile technologies, only the 58% of patients over 65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting, it suggest that it's applicability depends in patient's characteristics and it is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why the investigators believe that the next step should be to choose those patient's that doesn't use Internet or mobile technologies and to verify the applicability of a telematic system that could facilitate the extra hospital management of this patient's.

The aim of the study is to evaluate the telematic management of various outcomes that are emitted by CPAP machine, and by an app where the patient's will answer different questions regarding their treatment during the three months of study period.

详细描述

We include OSA patient's that are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow up an adaptation session where an automatic CPAP machine is delivered. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months.

The other part of the follow up consists on a voicemail where the patient can contact the sleep unit 24h a day and on a tablet, with an special app where the patient's answer a questionnaire once two weeks.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • OSA diagnosis and CPAP prescription
  • No use of internet or mobile devices

排除标准

  • Unstable diseases and severe comorbidities
  • Previous CPAP treatment

研究组 & 干预措施

Intervention group

Experimental

These OSA patient's are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow the intervetion follow up that consists in an adaptation session where the tecnitian delivers them an automatic CPAP machine. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months.

The other part of the follow up consists on a voicemail where the patient can contact us 24h a day and on an , with an internet-connected tablet with a special app where the patient's answer a questionnaire once two weeks.

干预措施: Telematic follow up (Other)

Control group

No Intervention

These patient's are patient's that follow the process that all patient's take during CPAP treatment. During the three months of study, the follow up will be the usual.

结局指标

主要结局

To evaluate the telematic CPAP follow up

时间窗: 3 months

CPAP adherence: Hours of use

次要结局

  • Efficacy of titration and follow up of data transmitted by CPAP(3 months)
  • Evaluate the effects of treatment in patient's symptomatology(3 months)
  • Evaluate the satisfaction of patient's and professionals(3 months)
  • Evaluate the effect of CPAP treatment and telematic follow up(3 months)
  • To compare the cost of the telematic follow up group vs hospital group(3 months)

研究者

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

Jose M. Montserrat

Medical Doctor

Hospital Clinic of Barcelona

研究点 (2)

Loading locations...

相似试验