Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

NCT01951261 | Completed Results DMC

• 1 other identifier: TELEMEDCOPD
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

Telemonitoring; COPD; Home care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• SATISFAD 10

  Participants will be followed for the duration home care, an expected average of 7 days

• State-Trait Anxiety Inventory (STAI)

  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

  Participants will be followed for the duration of home care up 24 weeks

• Monitoring Compliance

  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

Study Arms (2)

telemonitoring and telephone control

ACTIVE COMPARATOR

Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.

Procedure: Telemonitoring and telephone control

home care

NO INTERVENTION

Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits).

Interventions

Telemonitoring and telephone control PROCEDURE

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.

telemonitoring and telephone control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. López Viña: lead

Study Sites (1)

Universitary Hospital Puerta de Hierro.

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dra Patricia Mínguez Clemente
• Organization: Hospital Puerta de Hierro

drapat3@gmail.com

911916859

Study Officials

• Antolín Lopez Viña, physician

  Hospital Puerta de Hierro

  STUDY DIRECTOR

• Antolín Lopez Viña, MD

  Hospital Puerta de Hierro

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 26, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

ES (1)