The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05762861
Recruitment Status : Not yet recruiting
First Posted : March 10, 2023
Last Update Posted : March 10, 2023
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Maria Joao Barbosa, University of Minho

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Telemonitoring


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of COPD exacerbation with hospital admission [ Time Frame: 18 months ]
  2. Number of COPD exacerbation managed at home [ Time Frame: 18 months ]
  3. 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

  4. 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.

  5. Impact of the programme - rate of compliance [ Time Frame: 18 months ]
    Measurement tool - questionnaire

  6. Impact of the programme - satisfaction level [ Time Frame: 18 months ]
    Measurement tool - questionnaire

  7. Impact of the programme - % of retention of participating patients [ Time Frame: 18 months ]
    Measurement tool - questionnaire


Secondary Outcome Measures :
  1. Pulmonary function (FEV1 and FEV1/ FVC ratio after BD) [ Time Frame: 18 months ]
  2. Dyspnoea level (mMRC) [ Time Frame: 18 months ]
  3. Changes in GOLD classification [ Time Frame: 18 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • Aged 40 years or above
  • Must be enrolled in health centres from Braga
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05762861


Contacts
Layout table for location contacts
Contact: Maria João Barbosa, MD 00351968123187 mijoao@gmail.com

Sponsors and Collaborators
University of Minho
GlaxoSmithKline
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Maria Joao Barbosa, Principal investigator, University of Minho
ClinicalTrials.gov Identifier: NCT05762861    
Other Study ID Numbers: ISS 10805
First Posted: March 10, 2023    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes