Back to resultsEarly Assisted Discharge for COPD Exacerbations With Telemonitoring.
Primary Purpose
COPD Exacerbation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemonitoring and telephone control
Sponsored by
About this trial
This is an interventional health services research trial for COPD Exacerbation focused on measuring Telemonitoring, COPD, Home care
Eligibility 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.
Sites / Locations
- Universitary Hospital Puerta de Hierro.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
telemonitoring and telephone control
home care
Arm Description
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Number of Home Visits
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01951261
Brief Title
Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
Official Title
Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. López Viña
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
Telemonitoring, COPD, Home care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
telemonitoring and telephone control
Arm Type
Active Comparator
Arm Description
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Arm Title
home care
Arm Type
No Intervention
Arm Description
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits).
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring and telephone control
Intervention Description
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 Outcome Measure Information:
Title
Time Until the First Exacerbation
Description
Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.
Time Frame
Change from stable to exacerbation the first time at 6 month
Secondary Outcome Measure Information:
Title
SATISFAD 10
Description
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.
Time Frame
Participants will be followed for the duration home care, an expected average of 7 days
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
Participants will be followed for the duration of home care, an expected average of 7 days
Title
Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test
Description
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.
Time Frame
Participants will be followed for the duration of home care up 24 weeks
Title
Monitoring Compliance
Description
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.
Time Frame
Participants will be followed for the duration of home care, an expected average of 7 days
Title
Number of Home Visits
Time Frame
Participants will be followed for the duration of home care, an expected average of 7 days
Title
COPD Assessment Test (CAT)
Description
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.
Time Frame
Participants will be followed for the duration of home care and up to 4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antolín Lopez Viña, physician
Organizational Affiliation
Hospital Puerta de Hierro
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antolín Lopez Viña, MD
Organizational Affiliation
Hospital Puerta de Hierro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital Puerta de Hierro.
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
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