Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

Not Applicable

Completed

Conditions: COPD Exacerbation

Interventions: Procedure: Telemonitoring and telephone control

Registration Number: NCT01951261

Lead Sponsor: Dr. López Viña

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemonitoring and telephone control	Telemonitoring and telephone control	Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.

Primary Outcome Measures

Name	Time	Method
Time Until the First Exacerbation	Change from stable to exacerbation the first time at 6 month	Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.

Secondary Outcome Measures

Name	Time	Method
SATISFAD 10	Participants will be followed for the duration home care, an expected average of 7 days	Instrument that evaluates satisfaction with home care services in a self-administered. The score ranges from 0 to 30, with the worst value being zero and the best value being 30.
State-Trait Anxiety Inventory (STAI)	Participants will be followed for the duration of home care, an expected average of 7 days	The structure of the scale resulting from the combination of item polarity dimensions and the original two factors (State and Trait Anxiety). Minimum value 0, maximum value 120. Lower score indicates higher anxiety.
Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test	Participants will be followed for the duration of home care up 24 weeks	Consists of a series of 4 contrasting questions with answers dichotomous yes / no, reflecting the patient's behavior regarding compliance with medication. They are intended to assess whether the patient adopts correct attitudes regarding treatment for his illness; it is assumed that if attitudes they are incorrect the patient is non-compliant.
Monitoring Compliance	Participants will be followed for the duration of home care, an expected average of 7 days	It represents the compliance of the patients with respect to the sending of constants through the telemedicine monitor that should be (following the protocol) at least twice a day. The patient was considered compliant if he sent the constant at least 2 twice a day or non-compliant otherwise.
Number of Home Visits	Participants will be followed for the duration of home care, an expected average of 7 days
COPD Assessment Test (CAT)	Participants will be followed for the duration of home care and up to 4 weeks	It's a simple questionnaire for assessing and monitoring COPD. It quantifies chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment. It's self-administered in 2 min. It consists of 8 items that measure aspects of cough, expectoration, chest tightness, dyspnea, domestic activities, self-confidence, sleep and energy. Each section is scored from 0 to 5 and therefore a maximum of 40 points can be obtained; a higher score indicates a greater negative impact of COPD. Significant clinical changes correspond to a variation of 2 points or more.