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OpenTrials
Completed

NCT Number: NCT01951261

Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitary Hospital Puerta de Hierro.

Majadahonda, Madrid, 28222, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Time Until the First Exacerbation

    Time frame: 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 outcomes

  1. SATISFAD 10

    Time frame: 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.

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: 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.

  3. Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test

    Time frame: 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.

  4. Monitoring Compliance

    Time frame: 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.

  5. Number of Home Visits

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

  6. COPD Assessment Test (CAT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. López Viña

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2013
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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