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N/A N=197 Single-blind Prevention

Evaluation the Effectiveness of a Telemonitoring Program in a Cohort of COPD Patient With Frequent Readmissions

COPD

Enrolled (actual)
197
Serious AEs
1.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Hospitalizations for COPD Exacerbation (eCOPD) — 1.1; 2.8 number of hospital admissions

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
telEPOC (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Dr. Cristobal Esteban
Primary completion
Aug 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Hospitalizations for COPD Exacerbation (eCOPD)
1.1; 2.8

Summary

Observational non-randomized study with an intervention cohort from Hospital Galdakao-Usansolo with 119 patients and a control cohort from Hospital Cruces with 78 patients. The inclusion criteria were: being hospital admitted at least twice in the previous year or at least three times in the 2 previous years. The cohorts were follow-up for 2 years. Several clinical measurements like pulmonary function, exercise capacity, health related quality of life, limitation in daily life activities and anxiety and depression were recorded in both cohorts. Telemonitoring and an organized education program were only and exclusively applied in the intervention cohort.

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria established were: having a COPD (COPD was confirmed if the post-bronchodilator forced expiratory volume in one second (FEV1) divided by the forced vital capacity was less than 0.7 (FEV1/FVC<70%) and having been admitted at least twice in the previous year or three times in the two previous years for a COPD exacerbation (eCOPD).

Exclusion Criteria

  • Exclusion criteria were another significant respiratory disease, an active neoplasm, a terminal clinical situation, inability to carry out any of the measurements of the project, or unwillingness to take part in the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02528370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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