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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03799666
Other study ID # SAICT-POL/23926/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Aveiro University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Description:

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Study Design


Intervention

Other:
Pulmonary Rehabilitation
Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component
Daily medication
Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team.

Locations

Country Name City State
Portugal University of Aveiro Aveiro

Sponsors (2)

Lead Sponsor Collaborator
Aveiro University Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Body Mass Index Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight. Up to 9 months
Primary Change in Health Related quality-of-life: St. George Respiratory Questionnaire 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). Up to 9 months
Secondary Change in airflow obstruction Forced expiratory volume in one second and forced vital capacity will be measured with a portable spirometer to assess the degree of airflow obstruction. Results will be expressed in liters and percentage of predicted. We will calculate the ratio between the forced expiratory volume in one second and the forced vital capacity. Up to 9 months
Secondary Change in exercise capacity Exercise capacity will be tested in a 6-minute walk test, since it allows exercise prescription. The test results will be presented as the walked distance (meters). Up to 9 months
Secondary Change in functionality Functionality will be tested with the 1-minute sit-to-stand, with the results presented as number of sit-to-stand repetitions. Up to 9 months
Secondary Change in quadriceps muscle strength Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force). Up to 9 months
Secondary Change in biceps muscle strength Biceps muscle strength will be measured using a handheld dynamometer (kilogram/force). Up to 3 months
Secondary Change in muscle cross sectional area Cross-sectional will be measured with ultrasound of the lower (quadriceps) and upper (biceps) limb muscles. Up to 3 months
Secondary Change in upper limb muscle strength Upper limb strength will be measured with Handgrip (kg) Up to 9 months
Secondary Change in respiratory muscle strength Respiratory muscle strength will be measured through a respiratory pressure meter to assess inspiratory and expiratory muscle strength (cm/H20) Up to 3 months
Secondary Change in frequency of exacerbations Number of exacerbations in the previous year, healthcare utilization, such as emergency department visits or hospital admissions, in the previous year, which are related to COPD decline Up to 9 months
Secondary Change in Healthcare utilization Healthcare utilization will be assessed through the number of participants that visit emergency department and the number of visits of each participant in the previous year. The number and duration of hospital admissions in the previous year will also be assessed. Up to 9 months
Secondary Change in family adaptability/cohesion Family function was assessed with the family adaptability and cohesion evaluation scale (FACES-IV). The FACES-IV is a 62 items subdivided in: cohesion and flexibility dimensions, and family communication and family satisfaction scales. The cohesion and flexibility dimensions provide six family scales, two balanced scales (Balanced cohesion and balanced flexibility, with percentile scores ranging from 16 to 85) and four unbalanced scales (Disengaged, Enmeshed, Rigid and Chaotic, with percentile scores ranging from 10 to 99). The six family types (Balanced, Rigidly Cohesive, Midrange, Flexibly unbalanced, chaotically unbalanced and unbalanced) can be plotted onto the Circumplex Model. The family communications and Satisfaction scales are composed of 10 items each, with percentile scores ranging from 10 to 99. In all FACES-IV subscales higher scores indicate better family cohesion, flexibility, communication or satisfaction. Up to 3 months
Secondary Change in balance Balance will be assessed with the Brief-Best tests. Up to 3 months
Secondary Change in Physical activity Accelerometry will be used to assess physical activity. Up to 3 months
Secondary Change in Physical activity The Brief Physical Activity questionnaire will be used to assess physical activity. It a 2 items questionnaire, with scores ranging from 0 to 8. If the sum of the two items score is above or equal 4 the subject will be considered physically active. Up to 9 months
Secondary Change in Diaphragm excursion Ultrasound will be used to assess the diaphragm excursion, only volunteer from patients who agree to come to ESSUA and will be seen previously by a physician Up to 3 months
Secondary Change in Dyspnoea Medical Research Council scale will be used to assess functional dyspnoea related to respiratory impairment. It is a 5-point scale, rated from 0 to 4, with higher scores denoting greater breathlessness severity. Up to 9 months
Secondary Change in symptom's impact in patients life COPD Assessment Test (CAT) will be used to assess burdensome symptoms in patients' life with 8 items (cough, sputum, dyspnoea, chest tightness, capacity of exercise and home daily activities, confidence leaving home, sleep and energy levels).he scores range from 0-40, organised in 4 categories, namely <10 low impact, 10-20 medium, 21-30 high and >30 very high impact, with 5 representing the upper limit of normal in healthy non-smokers Up to 9 months
Secondary Change in Emotional state Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. It is a 14 item questionnaire that can be subdivided in two subscales: anxiety and depression. Scores are provided for each subscale and range from 0 to 21, with higher scores meaning more symptoms of anxiety and depression. Up to 9 months
Secondary Change in Fatigue symptoms The fatigue subscale of the Checklist of Individual Strength (CIS-20) will be used to assess fatigue.The subscale of subjective fatigue is a 8-item questionnaire, with higher scores indicating higher levels of fatigue. The total scores range from 8 to 56. Up to 3 months
Secondary Change in Fatigue The Functional Assessment of Cancer Therapy - Fatigue subscale (FACIT-F) will be used to assess fatigue levels. It is multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily activities due to fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue. Up to 3 months
Secondary Change in cough-related quality of life: Leicester Cough Questionnaire Cough-related quality of life will be assessed with the Leicester Cough Questionnaire, which is a 19 items scale organised in 3 domains (physical, psychological and social). Each domain has a score ranging from 1 to 7 and the LCQ total score varies from 3 to 21. Higher scores express a better quality of life and less impact of cough. Up to 3 months
Secondary Change in cough and sputum symptoms The Cough and Sputum Assessment Questionnaire (CASA-Q) will be used to assess cough and sputum symptoms, based on their reported frequency and severity, and their impact on daily activities. t is a 20-item questionnaire containing 4 domains: cough symptoms, cough impact, sputum symptoms and sputum impact. All items are rescored and summed, achieving a score ranging from 0 to 100 for each domain, with higher scores indicating fewer symptoms or less cough and sputum impact. Up to 3 months
Secondary Digital Technology access A survey asking about the use of internet and access to computers, smartphones (combination of mobile phone, web browser and computer capabilities)/tablets and cell phones (simple devices mainly for voice calls and text messages) will be used to assess digital technology access. Confidence in using these technologies will be assessed using a numerical scale from 0 (not at all confident) to 10 (completely confident). At baseline
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