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

Sponsor

University of Minho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05762861

Collaborator

GlaxoSmithKline (Industry)

200

Enrollment

Arms

Anticipated Duration (Months)

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
COPD Exacerbation	Other: Experimental	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

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

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

Number of COPD exacerbation with hospital admission [18 months]
Number of COPD exacerbation managed at home [18 months]
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
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.
Impact of the programme - rate of compliance [18 months]
Measurement tool - questionnaire
Impact of the programme - satisfaction level [18 months]
Measurement tool - questionnaire
Impact of the programme - % of retention of participating patients [18 months]
Measurement tool - questionnaire

Secondary Outcome Measures

Pulmonary function (FEV1 and FEV1/ FVC ratio after BD) [18 months]
Dyspnoea level (mMRC) [18 months]
Changes in GOLD classification [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Minho
GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Joao Barbosa, Principal investigator, University of Minho

ClinicalTrials.gov Identifier:

NCT05762861

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:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Mar 10, 2023