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Clinical Trials/NCT05762861
NCT05762861
Not yet recruiting
Not Applicable

Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort

University of Minho0 sites200 target enrollmentApril 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
University of Minho
Enrollment
200
Primary Endpoint
Impact of the programme - satisfaction level
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2023
End Date
April 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Joao Barbosa

Principal investigator

University of Minho

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Impact of the programme - satisfaction level

Time Frame: 18 months

Measurement tool - questionnaire

Number of COPD exacerbation with hospital admission

Time Frame: 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

Impact of the programme - rate of compliance

Time Frame: 18 months

Measurement tool - questionnaire

Impact of the programme - % of retention of participating patients

Time Frame: 18 months

Measurement tool - questionnaire

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.

Number of COPD exacerbation managed at home

Time Frame: 18 months

Secondary Outcomes

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

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