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临床试验/NCT03505138
NCT03505138已完成不适用

Impact of Telemedicine in the Rate of Readmission for COPD and Cost-effectiveness Analysis (e- Pneumo ) : Project CRONEX 3.0

Sociedad Española de Neumología y Cirugía Torácica2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年5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
120
试验地点
2
主要终点
Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.

研究概览

简要总结

The prevalence of COPD is high and suppose one of the first public health problem in the world. It has a high morbidity and mortality and healthcare costs. The economic aspect is directly related to hospitalization, accounting for 45-50% of total expenditure of COPD. Patients with frequent exacerbations generate most of the cost.

In these patients, there are not standardized treatments or monitoring in a medium or long term, but it seems reasonable that the combination of various interventions (programs self-care, active role of health professionals in consultations, home programs, group visits, establishment action plans for patients, use of communication technologies or social networks) may improve many patient outcomes.

The hypothesis of our work will be to introduce telemedicine platform to establish action plans for the patient, recognition of symptoms and exacerbations, treatments for the exacerbations, training material on COPD, smoking and inhalation therapy, establishment of a fast and fluid communication with pulmonologist, with the purpose of responding to various health problems that patients with COPD (exacerbator phenotype or ACO phenotype) may have. We will study the impact of this tool to reduce the rate income or readmission for the patients with COPD, analyzing it from the perspective of cost-effectiveness.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD, which after evaluation of its clinical history, belonging to exacerbator phenotype (chronic bronchitic / emphysema) or mixed phenotype ("COPD-asthma") readmission (2 or more income in the previous year) and are stable least six weeks before inclusion in the study.
  • Age over 18 years
  • The patient or caregiver should be able to use the tablet type telematic tool for tracking and monitoring.

排除标准

  • Patients with severe comorbidity grade IV heart failure, renal failure on hemodialysis or active neoplasia
  • Patients with difficulties phone coverage
  • Patients with lack of adequate social and family support.
  • Patients who do not grant informed consent

研究组 & 干预措施

Group intervention

Experimental

Conventional management for COPD will take place in our health care system more telematics intervention.

干预措施: Group intervention (Device)

Group control

Active Comparator

Is performed only conventional management of COPD in our health care system.

干预措施: health care system (Other)

结局指标

主要结局

Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.

时间窗: one year

outcome measure: the rate of readmissions during the study

次要结局

  • Make satisfaction survey patients and caregivers, comparing both study groups.(one year)
  • Compare the quality of life of COPD patients by measuring CAT in study groups(one year)
  • Analyze the survival at 12 months follow-up in each group.(one year)
  • Conducting a cost-effectiveness study that allows us to estimate the incremental cost-effectiveness ratio (ICER) of this patient group compared with the control group.(one year)
  • To study the evolution of lung function in both groups after 1 year of follow up.(one year)
  • Analyze the inhaler compliance and adherence of treatment in both groups.(one year)
  • Compare the quality of life of patients by measuring EQ-5D in study groups(one year)
  • Analyze a biomarker predictor of exacerbation severity.(one year)

研究者

发起方
Sociedad Española de Neumología y Cirugía Torácica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Corral Penafiel

Medical Doctor

Sociedad Española de Neumología y Cirugía Torácica

研究点 (2)

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