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NCT05762861 Clinical Trial

Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

COPD Exacerbation Clinical Trial

— EPISODE  

Official title:
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05762861
Other study ID # ISS 10805
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date April 2025

Study information
Verified date February 2023
Source University of Minho
Contact Maria João Barbosa, MD
Phone 00351968123187
Email mijoao@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study is to assess the feasibility and benefits of the implementation of an interactive telemonitoring system for earlier detection of COPD exacerbations in a community cohort preventing further deterioration requiring hospital admissions.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date April 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Diagnosis of COPD - Aged 40 years or above - Must be enrolled in health centres from Braga

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Experimental
Patients will be every two weeks monitored by the researchers' team, taking into consideration lung function, symptoms, physical activity, pulse oximetry, body temperature, need for relief medication and Sputum characteristics. Over the 18 months, they will be the target of health education interventions, 2 individual and 2 in group.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Minho GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary Number of COPD exacerbation with hospital admission 18 months
Primary Number of COPD exacerbation managed at home 18 months
Primary Quality of Life using St. George's Respiratory Questionnaire Scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived distress). A higher score means a poorer quality of life 18 months
Primary Impact of COPD on patient's life using COPD Assessment Test (CAT) Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. 18 months
Primary Impact of the programme - rate of compliance Measurement tool - questionnaire 18 months
Primary Impact of the programme - satisfaction level Measurement tool - questionnaire 18 months
Primary Impact of the programme - % of retention of participating patients Measurement tool - questionnaire 18 months
Secondary Pulmonary function (FEV1 and FEV1/ FVC ratio after BD) 18 months
Secondary Dyspnoea level (mMRC) 18 months
Secondary Changes in GOLD classification 18 months
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