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Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

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ClinicalTrials.gov Identifier: NCT01951261
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. López Viña, Puerta de Hierro University Hospital

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Procedure: Telemonitoring and telephone control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations
Actual Study Start Date : March 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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 (dairy visits).



Primary Outcome Measures :
  1. Time until the first exacerbation [ Time Frame: Change from stable to exacerbation the first time at 6 month ]

Secondary Outcome Measures :
  1. Satisfaction (SATISFAD 10) [ Time Frame: Participants will be followed for the duration home care, an expected average of 7 days ]
  2. Anxiety (STAI E-R) [ Time Frame: Participants will be followed for the duration of home care, an expected average of 7 days ]
  3. Quality of life (CAT) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days and for the duration of home care, an expected average of 7 days, up to 4 and 24 weeks ]
  4. Adhesion treatment(Morinsky-Green) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days and for the duration of home care, an expected average of 7 days, up to 4 and 24 weeks ]
  5. Monitoring compliance [ Time Frame: Participants will be followed for the duration of home care, an expected average of 7 days ]
  6. Use healthy resources [ Time Frame: Participants will be followed for the duration of home care, an expected average of 7 days, up to 4 and 24 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951261


Locations
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Spain
Universitary Hospital Puerta de Hierro.
Majadahonda, Madrid, Spain, 28222
Sponsors and Collaborators
Dr. López Viña
Investigators
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Study Director: Antolín Lopez Viña, physician Hospital Puerta de Hierro
Principal Investigator: Antolín Lopez Viña, MD Hospital Puerta de Hierro

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Responsible Party: Dr. López Viña, Investigator, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01951261    
Other Study ID Numbers: TELEMEDCOPD
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share All of the individual participant data collected during the trial, after identification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Immediately following publication. No end date.
Access Criteria: Proposals should be directed to drapat1@yahoo.es. To gain access, data requestors will need to sign a data access agreement.
Keywords provided by Dr. López Viña, Puerta de Hierro University Hospital:
Telemonitoring
COPD
Home care
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases