EPISODE: Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

University of Minho (Other)
Overall Status
Not yet recruiting
CT.gov ID
GlaxoSmithKline (Industry)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental

Study Design

Study Type:
Anticipated Enrollment :
200 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual follow up

Group 1: To keep follow-up in their usual family practice/ pulmonology consultations

Experimental: Home telemonitoring

Group 2: To keep follow-up in their usual family practice/ pulmonology consultations and associate an interactive home telemonitoring system managed by the researchers.

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.
Other Names:
  • Telemonitoring
  • Outcome Measures

    Primary Outcome Measures

    1. Number of COPD exacerbation with hospital admission [18 months]

    2. Number of COPD exacerbation managed at home [18 months]

    3. Quality of Life using St. George's Respiratory Questionnaire [18 months]

      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

    4. Impact of COPD on patient's life using COPD Assessment Test (CAT) [18 months]

      Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

    5. Impact of the programme - rate of compliance [18 months]

      Measurement tool - questionnaire

    6. Impact of the programme - satisfaction level [18 months]

      Measurement tool - questionnaire

    7. Impact of the programme - % of retention of participating patients [18 months]

      Measurement tool - questionnaire

    Secondary Outcome Measures

    1. Pulmonary function (FEV1 and FEV1/ FVC ratio after BD) [18 months]

    2. Dyspnoea level (mMRC) [18 months]

    3. Changes in GOLD classification [18 months]

    Eligibility Criteria


    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Diagnosis of COPD

    • Aged 40 years or above

    • Must be enrolled in health centres from Braga

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • University of Minho
    • GlaxoSmithKline


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Maria Joao Barbosa, Principal investigator, University of Minho
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • ISS 10805
    First Posted:
    Mar 10, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2023