Back to resultsExploring Clinical Predictors of COPD Exacerbation in a Community Cohort (EPISODE)
Primary Purpose
COPD Exacerbation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional other trial for COPD Exacerbation
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD Aged 40 years or above Must be enrolled in health centres from Braga
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual follow up
Home telemonitoring
Arm Description
Group 1: To keep follow-up in their usual family practice/ pulmonology consultations
Group 2: To keep follow-up in their usual family practice/ pulmonology consultations and associate an interactive home telemonitoring system managed by the researchers.
Outcomes
Primary Outcome Measures
Number of COPD exacerbation with hospital admission
Number of COPD exacerbation managed at home
Quality of Life using St. George's Respiratory Questionnaire
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)
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
Measurement tool - questionnaire
Impact of the programme - satisfaction level
Measurement tool - questionnaire
Impact of the programme - % of retention of participating patients
Measurement tool - questionnaire
Secondary Outcome Measures
Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)
Dyspnoea level (mMRC)
Changes in GOLD classification
Full Information
NCT ID
NCT05762861
First Posted
June 20, 2021
Last Updated
February 27, 2023
Sponsor
University of Minho
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT05762861
Brief Title
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
Acronym
EPISODE
Official Title
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minho
Collaborators
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual follow up
Arm Type
No Intervention
Arm Description
Group 1: To keep follow-up in their usual family practice/ pulmonology consultations
Arm Title
Home telemonitoring
Arm Type
Experimental
Arm Description
Group 2: To keep follow-up in their usual family practice/ pulmonology consultations and associate an interactive home telemonitoring system managed by the researchers.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
Telemonitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of COPD exacerbation with hospital admission
Time Frame
18 months
Title
Number of COPD exacerbation managed at home
Time Frame
18 months
Title
Quality of Life using St. George's Respiratory Questionnaire
Description
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
Time Frame
18 months
Title
Impact of COPD on patient's life using COPD Assessment Test (CAT)
Description
Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time Frame
18 months
Title
Impact of the programme - rate of compliance
Description
Measurement tool - questionnaire
Time Frame
18 months
Title
Impact of the programme - satisfaction level
Description
Measurement tool - questionnaire
Time Frame
18 months
Title
Impact of the programme - % of retention of participating patients
Description
Measurement tool - questionnaire
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)
Time Frame
18 months
Title
Dyspnoea level (mMRC)
Time Frame
18 months
Title
Changes in GOLD classification
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
Aged 40 years or above
Must be enrolled in health centres from Braga
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria João Barbosa, MD
Phone
00351968123187
Email
mijoao@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
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