Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort (EPISODE)

February 27, 2023 updated by: Maria Joao Barbosa, University of Minho
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria João Barbosa, MD
  • Phone Number: 00351968123187
  • Email: mijoao@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of COPD exacerbation with hospital admission
Time Frame: 18 months
18 months
Number of COPD exacerbation managed at home
Time Frame: 18 months
18 months
Quality of Life using St. George's Respiratory Questionnaire
Time Frame: 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
18 months
Impact of COPD on patient's life using COPD Assessment Test (CAT)
Time Frame: 18 months
Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
18 months
Impact of the programme - rate of compliance
Time Frame: 18 months
Measurement tool - questionnaire
18 months
Impact of the programme - satisfaction level
Time Frame: 18 months
Measurement tool - questionnaire
18 months
Impact of the programme - % of retention of participating patients
Time Frame: 18 months
Measurement tool - questionnaire
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)
Time Frame: 18 months
18 months
Dyspnoea level (mMRC)
Time Frame: 18 months
18 months
Changes in GOLD classification
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS 10805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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