Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
EPISODE
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedMarch 10, 2023
February 1, 2023
1.5 years
June 20, 2021
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
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
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)
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
Measurement tool - questionnaire
18 months
Impact of the programme - satisfaction level
Measurement tool - questionnaire
18 months
Impact of the programme - % of retention of participating patients
Measurement tool - questionnaire
18 months
Secondary Outcomes (3)
Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)
18 months
Dyspnoea level (mMRC)
18 months
Changes in GOLD classification
18 months
Study Arms (2)
Usual follow up
NO INTERVENTIONGroup 1: To keep follow-up in their usual family practice/ pulmonology consultations
Home telemonitoring
EXPERIMENTALGroup 2: To keep follow-up in their usual family practice/ pulmonology consultations and associate an interactive home telemonitoring system managed by the researchers.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- Aged 40 years or above
- Must be enrolled in health centres from Braga
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minholead
- GlaxoSmithKlinecollaborator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
June 20, 2021
First Posted
March 10, 2023
Study Start
April 1, 2023
Primary Completion
October 1, 2024
Study Completion
April 1, 2025
Last Updated
March 10, 2023
Record last verified: 2023-02