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临床试验/NCT02269618
NCT02269618已完成不适用

Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.

Fondazione Salvatore Maugeri3 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2013年6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
入组人数
113
试验地点
3
主要终点
Improvement tolerance capacity

研究概览

简要总结

The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity

详细描述

COPD and CHF frequently coexist, causing a significant worsening in the quality of life of the patients and increasing morbidity and mortality. The prevalence of COPD in the CHF patients ranges from 20% to 32% of cases, and CHF is prevalent in more than 20% of patients with COPD.

COPD and CHF patients are complicated and frail with a high risk of re-hospitalizations; for this reason an individualized and multidisciplinary program need to be implemented in these patients. The chronic disease trend is fluctuating, burdened by many exacerbations through a vicious circle with dyspnoea, decreased activity, new exacerbations, depression and social isolation, leading to death.

The weight of evidence from a meta-analysis of randomized trials indicates that a multidisciplinary disease-management approach has the best outcomes in terms of prolonged survival and reduced hospital-readmission rates. Home-based management might, arguably, be the preferred approach after hospitalization of chronic diseases patients.

Home-base management might provide an opportunity to prevent clinical deterioration and hospitalizations by a comprehensive, long-term intervention with regular reinforcement of patient adherence, knowledge, and skills. A personalized hospital-discharge programme seems to be the best approach to plan the follow-up care of patients with chronic diseases.

These programmes, particularly important in the care of patients with multiple comorbidities, should include a routine self-management support, consisting in education to recognize symptoms early, to manage medical devices, to identify barriers to adherence to therapy such as adverse effects of drugs, and to check that the intensity of physical therapy is appropriate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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
否

入选标准

  • •COPD new GOLD classification (B, C and D class) and a spirometry in the previous year and
  • •Systolic and/or diastolic CHF defined at least by an echocardiogram performed in clinical stability; II, III and IV New York Heart Association class and optimized drug therapy.
  • •Informed consent signed

排除标准

  • •Physical activity limitations caused by non-cardiac and/or pulmonary problems
  • •Obstructive Cardiomyopathies and/or myocarditis
  • •Non cardiac and/or pulmonary pathologies that would cause the death of the patient during the study
  • •Poor adherence and compliance of the patient

研究组 & 干预措施

Control group (Group A)

Active Comparator

The patients will be followed in the usual care manner by GPs and by routine specialist visits, if needed

干预措施: Usual care (Other)

Intervention group (Group B)

Other

Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be:

  1. Home-based telehealth program
  2. Home-based rehabilitation

干预措施: Home-based telehealth program (Other)

Intervention group (Group B)

Other

Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be:

  1. Home-based telehealth program
  2. Home-based rehabilitation

干预措施: Home-based rehabilitation (Other)

Intervention group (Group B)

Other

Group B (Home-based intervention): the patients will be followed at home for 4 months by nurse and therapist and will perform an individual rehabilitative program. The interventions will be:

  1. Home-based telehealth program
  2. Home-based rehabilitation

干预措施: Usual care (Other)

结局指标

主要结局

Improvement tolerance capacity

时间窗: 4 months and 6 months

The improvement in tolerance capacity will be measured by walking test performance (meters walked)

次要结局

  • Reduction of hospitalisations for cardiovascular disease and /or respiratory disease(4 months)
  • Reduction of hospitalisations for all-cases(4 months)
  • Improvement of quality of life(4 months)
  • energy expenditure and duration and quantification of physical activity Energy expenditure and duration and quantification of physical activity(4 months and 6 months)
  • Reduction of impairment/disability(4 months)
  • Reduction of clinical instabilities without hospital admission(4 months)
  • Adherence to at least 70% proposal rehabilitative sessions(4 months and 6 months)

研究者

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

Michele Vitacca

Responsible of Respiratory Unit

Fondazione Salvatore Maugeri

研究点 (3)

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