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临床试验/NCT03799666
NCT03799666已完成不适用

(Re)Vitalizing Pulmonary Rehabilitation

Aveiro University2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2019年1月7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
146
试验地点
2
主要终点
Change in Health Related quality-of-life: St. George Respiratory Questionnaire

研究概览

简要总结

3R aims to increase the access of patients with chronic respiratory diseases (CRD) to pulmonary rehabilitation (PR) in Portugal. The main goals of 3R are: i) design and implement an innovative community-based PR programme; ii) assess the cost-benefit of the community-based PR programme; iii) disseminate and perform knowledge transfer about PR across the country.

PR is an evidence-based intervention for the management of CRD and offering PR has been defined as a priority by national/international organizations. However, in Portugal PR is practically inexistent (<1% of "candidate" patients have access). Currently, PR programmes are hospital-based and directed to patients with advanced disease. One of the recommendations to enhance the implementation of PR is the development on novel models of programme delivery. It is hypothesised that community-based programs, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients, society, policy makers) may turn PR more accessible.

The plan is to implement community-based PR programs in 4 primary care centres of 2 ACES of the centre region of Portugal and assess the impact of such intervention in several domains using surrogate and patient-/family-centered outcomes. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization. Dissemination will include one conference, activities with the community, courses and an online PR toolkit. Four schools of 2 polytechnics, 2 city councils, the Health Regional Administration-Centre (ARS-Centro) and all respiratory professional and civic national associations are partners.

详细描述

More than 1 billion people suffer from chronic respiratory diseases worldwide and, in Europe, the total annual cost of respiratory diseases amounts to more than €380 billion. In Portugal, respiratory diseases are the 3rd leading cause of death and direct costs related to hospitalizations (in 2013 - €213 millions). Management of chronic respiratory diseases are high priorities for the National Health Service, and particularly, for the Center Health Regional Administration.

Pulmonary rehabilitation (PR) is an evidence-based intervention for the management of patients with chronic respiratory diseases (grade A). Offering PR has long been defined as a priority by several national and international organizations. Despite this firm recommendation and the knowhow on the provision of PR, in Portugal, PR is practically inexistent, with <1% of "candidate" patients having access to this standard care. Therefore, the need for a National Network on PR has been acknowledged as a priority.

It is hypothesised that community-based programmes, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients/family, society, policy makers) may turn PR more accessible. Thus, the main goal of this project is to increase the access of patients with chronic respiratory diseases, namely COPD, to PR in the center region of Portugal and disseminate this intervention nationally.

3R aims to implement and disseminate community-based PR programs in Portugal. Specifically, it will:

  1. Implement 4 community-based PR programmes (Task 1);
  2. Create an online platform for clinical storage and analysis of the data collected (Task 2);
  3. Perform a cost-benefit analysis of the implemented PR programmes (Task 3);
  4. Create a Portuguese online PR toolkit (Task 4);
  5. Promote knowledge transfer about PR (Task 5). The plan is to implement community-based PR programmes in 4 primary care centres of 2 ACES (Baixo Vouga - BV, and Baixo-Mondego - BM) of the centre region and assess the impact of such intervention in several domains. Surrogate and patient/family centered outcome measures will be used. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization and costs. Finally, dissemination and knowledge transfer of the project will be conducted through: an international conference, activities with the community, three PR courses; the development of the Portuguese online PR toolkit to support the widespread implementation of PR in Portugal and via publications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

  • clinical diagnosis of a chronic respiratory disease
  • clinically stable in the previous month
  • ≥ 18 years old
  • able to provide their own informed consent

排除标准

  • cognitive impairments
  • inability to understand and co-operate
  • history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.

结局指标

主要结局

Change in Health Related quality-of-life: St. George Respiratory Questionnaire

时间窗: Up to 9 months

St. George Respiratory Questionnaire (SGRQ) will be used to assess Health Related quality-of-life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with chronic respiratory diseases. Scores can be provided for each domain and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status).

次要结局

  • Change in biceps muscle strength(Up to 3 months)
  • Change in cough and sputum symptoms(Up to 3 months)
  • Change in cough-related quality of life: Leicester Cough Questionnaire(Up to 3 months)
  • Change in airflow obstruction(Up to 9 months)
  • Change in functionality(Up to 9 months)
  • Change in exercise capacity(Up to 9 months)
  • Change in muscle cross sectional area(Up to 3 months)
  • Change in respiratory muscle strength(Up to 3 months)
  • Change in frequency of exacerbations(Up to 9 months)
  • Change in Healthcare utilization(Up to 9 months)
  • Change in balance(Up to 3 months)
  • Change in Diaphragm excursion(Up to 3 months)
  • Change in Emotional state(Up to 9 months)
  • Change in Fatigue symptoms(Up to 3 months)
  • Change in Fatigue(Up to 3 months)
  • Change in quadriceps muscle strength(Up to 9 months)
  • Change in upper limb muscle strength(Up to 9 months)
  • Change in Dyspnoea(Up to 9 months)
  • Change in symptom's impact in patients life(Up to 9 months)
  • Change in family adaptability/cohesion(Up to 3 months)
  • Change in Physical activity(Up to 9 months)
  • Digital Technology access(At baseline)

研究者

发起方
Aveiro University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alda Sofia Pires de Dias Marques

Senior Lecturer

Aveiro University

研究点 (2)

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