Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

COPD Exacerbation Clinical Trial

Official title:

Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951261
• Other study ID #: TELEMEDCOPD
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Telemonitoring and telephone control
Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.

Locations

Country	Name	City	State
Spain	Universitary Hospital Puerta de Hierro.	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Dr. López Viña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Until the First Exacerbation	Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.	Change from stable to exacerbation the first time at 6 month
Secondary	SATISFAD 10	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.	Participants will be followed for the duration home care, an expected average of 7 days
Secondary	State-Trait Anxiety Inventory (STAI)	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.	Participants will be followed for the duration of home care, an expected average of 7 days
Secondary	Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test	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.	Participants will be followed for the duration of home care up 24 weeks
Secondary	Monitoring Compliance	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.	Participants will be followed for the duration of home care, an expected average of 7 days
Secondary	Number of Home Visits		Participants will be followed for the duration of home care, an expected average of 7 days
Secondary	COPD Assessment Test (CAT)	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.	Participants will be followed for the duration of home care and up to 4 weeks