Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

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

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Procedure: Telemonitoring and telephone control

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Universitary Hospital Puerta de Hierro.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: telemonitoring and telephone control; Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.	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.
No Intervention: home care; Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Number of Home Visits		Participants will be followed for the duration of home care, an expected average of 7 days
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

Collaborators and Investigators

• Sponsor: Dr. López Viña
• Investigators: Principal Investigator: Antolín Lopez Viña, MD, Hospital Puerta de Hierro; Study Director: Antolín Lopez Viña, physician, Hospital Puerta de Hierro

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: COPD; Telemonitoring; Home care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TELEMEDCOPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share All of the individual participant data collected during the trial, after identification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Proposals should be directed to drapat1@yahoo.es. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR