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临床试验/NCT02499068
NCT02499068已完成不适用

Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).

Arturo Garcia10 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2013年12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
237
试验地点
10
主要终点
Number of hospitalizations due to exacerbation of COPD avoided

研究概览

简要总结

The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period

The primary endpoint of effectiveness is "severe exacerbations avoided."

The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.

详细描述

Randomized, controlled, multicenter, performance, cost assessment and economic evaluation clinical trial. An arm of the trial will consist of patients assigned to the intervention group (telehealth group: TG ), and the other arm will consist of patients randomized to the control group (routine clinical practice: RCP).

For the economic evaluation, the perspective of the health system will be used. Therefore it only direct costs will be considered. In the TG arm also intervention costs it will be considered.

Patient selection:

Responsible researcher at each hospital center will coordinate the patient selection process. The researchers will identify candidate patients screening through hospital medical records.

After this first screening, patients will be contacted and invited to participate in the study. In a personal interview, the researcher explains the study to the patient and deliver the information sheet, verifying that patient meets all inclusion/exclusion criteria, obtains informed consent and then proceeds to patient randomization. To avoid bias from exclusions, researchers will hold record with patient exclusion causes.

研究设计

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

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 50 and under 90 years of age.
  • Being diagnosed with COPD according to the criteria of GesEPOC, with severe airflow obstruction defined as a forced expiratory volume in one second (FEV1) less than 50% of theoretical.
  • "Exacerbator phenotype" defined as COPD patients having two or more moderate or severe exacerbations per year (GesEPOC guide). These exacerbations should be separated by at least 4 weeks after the end of previous treatment or 6 weeks from the start in cases that have not been treated
  • Clinically stable condition, defined as 6 weeks without clinical symptoms since the last exacerbation of COPD.
  • Having home oxygen therapy.
  • Sign the informed consent.

排除标准

  • Inability of the patient or caregiver to understand the procedure of Telehealth program.
  • Have a life expectancy of less than one year.
  • Have terminal heart failure (NYHA functional class III-IV).
  • Having advanced renal insufficiency (creatinine clearance <30%) or be on dialysis program.
  • Have liver cirrhosis or be included in a program of liver transplantation.
  • Be institutionalized or in Residential hospice care.
  • Having a mini-mental test-score less than 24, because this score suggests dementia
  • To be considered by your doctor as not comply the treatment or monitoring required by their lung disease.
  • Failure to meet any of the inclusion criteria.

研究组 & 干预措施

COPD, Telehealth

Experimental

Patients randomized to this arm would be followed by home telehealth devices and monitored on a daily bases for early detection of exacerbations and prompt clinical intervention.

干预措施: Telehealth (Device)

COPD, Normal clinical practice

No Intervention

Patients would do the usual clinical practice.

结局指标

主要结局

Number of hospitalizations due to exacerbation of COPD avoided

时间窗: 1 year

次要结局

  • Cost-efficiency of treatment(1 year)
  • satisfaction of both patients and clinician responsibility questionnaire(1 year)
  • Cost-utility of treatment(1 year)

研究者

发起方
Arturo Garcia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arturo Garcia

Fundación Teófilo Hernando

Fundación Teófilo Hernando, Spain

研究点 (10)

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