Skip to content

Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05762861
Acronym
EPISODE
Enrollment
200
Registered
2023-03-10
Start date
2023-04-30
Completion date
2025-04-30
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Brief 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.

Interventions

OTHERExperimental

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.

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
University of Minho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of COPD * Aged 40 years or above * Must be enrolled in health centres from Braga

Design outcomes

Primary

MeasureTime frameDescription
Impact of the programme - % of retention of participating patients18 monthsMeasurement tool - questionnaire
Impact of COPD on patient's life using COPD Assessment Test (CAT)18 monthsRange of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Impact of the programme - rate of compliance18 monthsMeasurement tool - questionnaire
Impact of the programme - satisfaction level18 monthsMeasurement tool - questionnaire
Number of COPD exacerbation with hospital admission18 months
Number of COPD exacerbation managed at home18 months
Quality of Life using St. George's Respiratory Questionnaire18 monthsScores 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

Secondary

MeasureTime frame
Dyspnoea level (mMRC)18 months
Changes in GOLD classification18 months
Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)18 months

Contacts

Primary ContactMaria João Barbosa, MD
mijoao@gmail.com00351968123187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026