Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-03-02 @ 10:23 PM
Study NCT ID:
NCT02499068
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Madrid Project on the Management of Chronic Obstructive Pulmonary Disease With Home Telemonitoring
Sponsor:
Arturo Garcia
Organization:
Study Overview
Official Title:
Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMETE
Brief Summary:
The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period
The primary endpoint of effectiveness is "severe exacerbations avoided."
The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.
The primary endpoint of effectiveness is "severe exacerbations avoided."
The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.
Detailed Description:
Randomized, controlled, multicenter, performance, cost assessment and economic evaluation clinical trial. An arm of the trial will consist of patients assigned to the intervention group (telehealth group: TG ), and the other arm will consist of patients randomized to the control group (routine clinical practice: RCP).
For the economic evaluation, the perspective of the health system will be used. Therefore it only direct costs will be considered. In the TG arm also intervention costs it will be considered.
Patient selection:
Responsible researcher at each hospital center will coordinate the patient selection process. The researchers will identify candidate patients screening through hospital medical records.
After this first screening, patients will be contacted and invited to participate in the study. In a personal interview, the researcher explains the study to the patient and deliver the information sheet, verifying that patient meets all inclusion/exclusion criteria, obtains informed consent and then proceeds to patient randomization. To avoid bias from exclusions, researchers will hold record with patient exclusion causes.
Every hospital centers will include on average 60 patients (30 in each arm). The inclusion of patients will be competitive; having centers including patients in the study until reaching the final sample size of 120 patients per arm.
Randomization:
To avoid selection bias, patients assigned to each group will be randomized. To ensure that the number of subjects in each arm is the same, a restrictive block randomization is performed. Randomization is performed using random number generation by computer and the block size of 10 units.
Home Telehealth program:
Vital sign devices being used: spirometer, pulse oximeter with capacity for heart rate monitor, blood pressure, Visionox® (device capable of measuring respiratory rate, compliance with the hours of oxygen, and the flow and pattern of oxygen used).
Devices send data automatically to a modem by Bluetooth. Modem receives and transmits data simultaneously from the monitoring devices to a Central Monitoring Center (CMC). Data received by the modem are encrypted and sent to the telehealth monitoring platform via a 3G signal.
The CMC is manned by registered nurses and operates during office hours, 7 days a week.
Nurses will attend the patient's home for: the installation of the telehealth devices; to perform a thorough training of the patients / caregivers in the use of equipment and the COPD telehealth program.
Patients will perform daily vital sign measurements at the same time, at rest, after administration of the medication and the pattern of oxygen used. Visionox® performs measurements of respiratory rate and oxygen adherence automatically.
Measured data will be monitored on a daily bases by the nurses at the CMC. CMC will follow-up information, filter for fle positives and false negatives, and use an application acting as a traffic light system:
* Green: meant that measurements had been taken and were within the predefined limits, and no further action was required.
* Yellow: "technical alert". This means that the measurements had not been taken or had not been received. This alert could lead to a "clinical alert" due to a lack of adherence or discouragement. When the parameters were not received the nurse at the CMC called the patient to find the reason behind the alert, and either ruled out medical causes or, if one, notified the researcher leading the study.
* Red: "clinical alert". Meant that a measurement exceeded the limits that were previously preestablished for each.
Classification of severity of clinical alerts is performed by the CMC according to an algorithm. Depending n severity different early medical interventions are taken, or escalated to clinical responsible for early intervention.
For the economic evaluation, the perspective of the health system will be used. Therefore it only direct costs will be considered. In the TG arm also intervention costs it will be considered.
Patient selection:
Responsible researcher at each hospital center will coordinate the patient selection process. The researchers will identify candidate patients screening through hospital medical records.
After this first screening, patients will be contacted and invited to participate in the study. In a personal interview, the researcher explains the study to the patient and deliver the information sheet, verifying that patient meets all inclusion/exclusion criteria, obtains informed consent and then proceeds to patient randomization. To avoid bias from exclusions, researchers will hold record with patient exclusion causes.
Every hospital centers will include on average 60 patients (30 in each arm). The inclusion of patients will be competitive; having centers including patients in the study until reaching the final sample size of 120 patients per arm.
Randomization:
To avoid selection bias, patients assigned to each group will be randomized. To ensure that the number of subjects in each arm is the same, a restrictive block randomization is performed. Randomization is performed using random number generation by computer and the block size of 10 units.
Home Telehealth program:
Vital sign devices being used: spirometer, pulse oximeter with capacity for heart rate monitor, blood pressure, Visionox® (device capable of measuring respiratory rate, compliance with the hours of oxygen, and the flow and pattern of oxygen used).
Devices send data automatically to a modem by Bluetooth. Modem receives and transmits data simultaneously from the monitoring devices to a Central Monitoring Center (CMC). Data received by the modem are encrypted and sent to the telehealth monitoring platform via a 3G signal.
The CMC is manned by registered nurses and operates during office hours, 7 days a week.
Nurses will attend the patient's home for: the installation of the telehealth devices; to perform a thorough training of the patients / caregivers in the use of equipment and the COPD telehealth program.
Patients will perform daily vital sign measurements at the same time, at rest, after administration of the medication and the pattern of oxygen used. Visionox® performs measurements of respiratory rate and oxygen adherence automatically.
Measured data will be monitored on a daily bases by the nurses at the CMC. CMC will follow-up information, filter for fle positives and false negatives, and use an application acting as a traffic light system:
* Green: meant that measurements had been taken and were within the predefined limits, and no further action was required.
* Yellow: "technical alert". This means that the measurements had not been taken or had not been received. This alert could lead to a "clinical alert" due to a lack of adherence or discouragement. When the parameters were not received the nurse at the CMC called the patient to find the reason behind the alert, and either ruled out medical causes or, if one, notified the researcher leading the study.
* Red: "clinical alert". Meant that a measurement exceeded the limits that were previously preestablished for each.
Classification of severity of clinical alerts is performed by the CMC according to an algorithm. Depending n severity different early medical interventions are taken, or escalated to clinical responsible for early intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: