N/A
N=116
Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
COPD Exacerbation
Bottom Line
View on ClinicalTrials.gov: NCT01951261 ↗Enrolled (actual)
116
Serious AEs
3.5%
Results posted
Oct 2020
Primary outcome: Primary: Time Until the First Exacerbation — 47; 48 days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telemonitoring and telephone control (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dr. López Viña
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Until the First Exacerbation |
47; 48 | <0.05 sig |
| SECONDARY SATISFAD 10 |
30; 30 | — |
| SECONDARY State-Trait Anxiety Inventory (STAI) |
15; 17; 20; 23 | — |
| SECONDARY Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test |
77; 78; 86; 87 | — |
| SECONDARY Monitoring Compliance |
2.23 | — |
| SECONDARY Number of Home Visits |
3.8; 5.1 | — |
| SECONDARY COPD Assessment Test (CAT) |
10; 15; 8; 8 | — |
Summary
To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD), with telemonitoring and telephone control, is equally effective and more efficient in terms of use of health care resources, that a home care provided by hospital respiratory nurses and pulmonologists.
Eligibility Criteria
Inclusion Criteria
- Patients admitted to the hospital with COPD exacerbation
- No concomitant serious unstable diseases
- Without fever in 48 hours
- Aerosol treatment at the most every 6 hours
- Treatment with glucocorticoid intravenous < 40 mg twice a day
- A thoracic radiograph without new disease
- Subjective improvement of the patient
- Familiar suitable environment
Exclusion Criteria
- Neoplasias and other chronic diseases in terminal situation
- Alcoholism
- Intravenous medication
- Disability to understand and take part in the program
- Admitted to intensive care unit (ICU) or non invasive mechanical ventilation during the exacerbation
- Unstability hemodynamic
- To be an institutionalized patient.
Data sourced from ClinicalTrials.gov (NCT01951261). 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.