(Re)Vitalizing Pulmonary Rehabilitation for Patients With Chronic Respiratory Diseases — 3R  

Chronic Respiratory Disease Clinical Trial

Official title: (Re)Vitalizing Pulmonary Rehabilitation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

To bring PR from bench to Portuguese common practice, 3R brings together a strong consortium composed of 4 schools of 2 Polytechnic Institutions, 2 City Councils, Health Regional Administration - Centre and all respiratory national associations (Sociedade, Portuguesa do Pulmão - SPP, RESPIRA and Fundação Portuguesa do Pulmão - FPP). This consortium involves an experienced team with complementary backgrounds and integrates students from the several institutions during all activities. It is strongly believed that jointly this multidisciplinary team has the experience and complementary skills, as well as the means, to guarantee the success and outreach of the project.

It is estimated that 73 patients will be required to detect significant differences in patients' health-related quality of life (HRQOL), based on a previous study. Stable patients with CRD and their family members will be recruited from Primary Care Centres (PCCs) of the ACES of Baixo Vouga and Baixo Mondego (ACES-BV & BM). Family doctors from PCCs will provide a list of eligible individuals. Individuals/families will be contacted and those interested will meet with researchers to receive further information about the study and sign the informed consents. Participants will be divided in two groups: experimental (EG) and control (CG). The EG will include participants/families wanting to participate in a 12-week community-based PR programme and the CG will include those willing to collaborate in data collection but not in the PR programmes (Task 1). The PR programme will include exercise training (endurance, strength and balance training) twice a week and psychoeducational sessions every two weeks performed by a multidisciplinary team.

Data will be collected at baseline, at 12 weeks (i.e., immediately post-PR), 3 and 6 months post-PR.

Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compared. Moreover, between groups comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated. ;

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases

• NCT number: NCT03799666
• Study type: Interventional
• Source: Aveiro University
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Completion date: June 30, 2020