COPD Clinical Trial
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).
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06000696 -
Healthy at Home Pilot
|
||
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04105075 -
COPD in Obese Patients
|
||
Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
|
Phase 2/Phase 3 | |
Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|
||
Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
|
N/A | |
Terminated |
NCT03284203 -
Feasibility of At-Home Handheld Spirometry
|
N/A | |
Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06040424 -
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
Completed |
NCT04485741 -
Strados System at Center of Excellence
|
||
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A |