Clinical trial NCT01951261: Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
Official title: Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Keywords: Telemonitoring
COPD
Home care
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This study seeks to improve the health of patients with AECOPD by home care after discharge from the Hospital using the technology of the information and the communication. The investigators want evaluate the efficiency, satisfaction (patients, keepers) and effectiveness of a program of early discharge with home care in patients with AECOPD with telemonitoring and telephone control, in relation to the traditional protocol of home care based on nurse and pulmonologist visits.

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.

Primary outcomes:
measure: Time Until the First Exacerbation
timeFrame: Change from stable to exacerbation the first time at 6 month
Secondary outcomes:
measure: SATISFAD 10
timeFrame: Participants will be followed for the duration home care, an expected average of 7 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Participants will be followed for the duration of home care, an expected average of 7 days
measure: Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test
timeFrame: Participants will be followed for the duration of home care up 24 weeks
measure: Monitoring Compliance
timeFrame: Participants will be followed for the duration of home care, an expected average of 7 days
measure: Number of Home Visits
timeFrame: Participants will be followed for the duration of home care, an expected average of 7 days
measure: COPD Assessment Test (CAT)
timeFrame: Participants will be followed for the duration of home care and up to 4 weeks
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Universitary Hospital Puerta de Hierro.
state: Madrid
Study officials:
affiliation: Hospital Puerta de Hierro
name: Antolín Lopez Viña, physician
role: STUDY_DIRECTOR
affiliation: Hospital Puerta de Hierro
name: Antolín Lopez Viña, MD
role: PRINCIPAL_INVESTIGATOR
References: