COPD ExacerbationNCT01951261
Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
A study of COPD Exacerbation, run by Dr. López Viña at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD Exacerbation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD Exacerbation
- Being tested
- Telemonitoring and telephone control
- Keywords
- Telemonitoring, COPD, Home care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring and telephone controlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| telemonitoring and telephone control | Active comparator | Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from stable to exacerbation the first time at 6 month
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants will be followed for the duration of home care, an expected average of 7 days
Number of Home Visits
Measured: 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.
Measured: Participants will be followed for the duration of home care and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. López Viña
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. López Viña, Puerta de Hierro University Hospital
- Investigators
- Antolín Lopez Viña, physician, Study director, Hospital Puerta de HierroAntolín Lopez Viña, MD, Principal investigator, Hospital Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951261
- Sponsor's protocol ID
- TELEMEDCOPD
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2013
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Share All of the individual participant data collected during the trial, after identification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations
- ClinicalTrials.gov ID
- NCT01951261
- Acronym / sponsor ID
- TELEMEDCOPD
- Conditions
- COPD Exacerbation
- Keywords
- Telemonitoring, COPD, Home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Dr. López ViñaUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemonitoring and telephone control | Active comparator | Procedure: Telemonitoring and telephone controlEarly discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits. |
| home care | No intervention | –Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring and telephone controlEarly 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. | Procedure or surgery | telemonitoring and telephone control |
Primary outcome
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.
6 secondary outcomes
SATISFAD 10
Time frame: Participants will be followed for the duration home care, an expected average of 7 days
State-Trait Anxiety Inventory (STAI)
Time frame: 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
Time frame: Participants will be followed for the duration of home care up 24 weeks
Monitoring Compliance
Time frame: Participants will be followed for the duration of home care, an expected average of 7 days
Number of Home Visits
Time frame: Participants will be followed for the duration of home care, an expected average of 7 days
COPD Assessment Test (CAT)
Time frame: Participants will be followed for the duration of home care and up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Share All of the individual participant data collected during the trial, after identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antolín Lopez Viña, physician study director
Hospital Puerta de Hierro
Antolín Lopez Viña, MD principal investigator
Hospital Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of COPD Exacerbation, run by Dr. López Viña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Until the First Exacerbation (time frame: Change from stable to exacerbation the first time at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.