Impact of Telemedicine in the Rate of Readmission for COPD. Project CRONEX 3.0

Study Overview
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Brief Summary
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The prevalence of COPD is high and suppose one of the first public health problem in the world. It has a high morbidity and mortality and healthcare costs. The economic aspect is directly related to hospitalization, accounting for 45-50% of total expenditure of COPD. Patients with frequent exacerbations generate most of the cost. In these patients, there are not standardized treatments or monitoring in a medium or long term, but it seems reasonable that the combination of various interventions (programs self-care, active role of health professionals in consultations, home programs, group visits, establishment action plans for patients, use of communication technologies or social networks) may improve many patient outcomes. The hypothesis of our work will be to introduce telemedicine platform to establish action plans for the patient, recognition of symptoms and exacerbations, treatments for the exacerbations, training material on COPD, smoking and inhalation therapy, establishment of a fast and fluid communication with pulmonologist, with the purpose of responding to various health problems that patients with COPD (exacerbator phenotype or ACO phenotype) may have. We will study the impact of this tool to reduce the rate income or readmission for the patients with COPD, analyzing it from the perspective of cost-effectiveness.

Official Title
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Impact of Telemedicine in the Rate of Readmission for COPD and Cost-effectiveness Analysis (e- Pneumo ) : Project CRONEX 3.0

Conditions
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COPD

Intervention / Treatment
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* Device: Group intervention
* Other: health care system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD, which after evaluation of its clinical history, belonging to exacerbator phenotype (chronic bronchitic / emphysema) or mixed phenotype (COPD-asthma) readmission (2 or more income in the previous year) and are stable least six weeks before inclusion in the study. Age over 18 years The patient or caregiver should be able to use the tablet type telematic tool for tracking and monitoring. Exclusion Criteria: Patients with severe comorbidity grade IV heart failure, renal failure on hemodialysis or active neoplasia Patients with difficulties phone coverage Patients with lack of adequate social and family support. Patients who do not grant informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group intervention<br>Conventional management for COPD will take place in our health care system more telematics intervention. | Device: Group intervention<br>* GROUP 1 (telematic group): These patients will have a tablet connected via internet (Telefónica-e-Health). They have to measure their lung function, temperature, pulse oxymetry and symtoms questionnaire every week. The device (tablet) asks them about possible COPD exacerbation. If the patient has an exacerbation, the device offers them a treatment for this exacerbation and it begins a following of this exacerbation until resolution, every day. The pneumologists will receive an alert in other tablet when the patients have an exacerbation or worsening of their diseases. The period of monitoring is 1 year.<br>* Other names: Telematic intervention;|
| Active Comparator: Group control<br>Is performed only conventional management of COPD in our health care system. | Other: health care system<br>* GROUP 2 (conventional group or control group) Patients with a COPD exacerbation can go to their family physicians or emergency services and these physicians will establish a treatment and a monitoring of these exacerbation (conventional group). The period of monitoring is 1 year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management. | outcome measure: the rate of readmissions during the study | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conducting a cost-effectiveness study that allows us to estimate the incremental cost-effectiveness ratio (ICER) of this patient group compared with the control group. | outcome measure: incremental cost-effectiveness ratio (ICER) between these two arms | one year | 
| Compare the quality of life of COPD patients by measuring CAT in study groups | outcome measure: quality of life measured by CAT questionnaire | one year | 
| To study the evolution of lung function in both groups after 1 year of follow up. | outcome measure: lung function by spirometry (FEV1/FVC, FVC, FEV1) | one year | 
| Analyze the survival at 12 months follow-up in each group. | outcome measure: number of deaths in each group to see the survival in this study | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: PCR (mg/L) | one year | 
| Analyze the inhaler compliance and adherence of treatment in both groups. | outcome measure: Morisky-Green´s scoring | one year | 
| Make satisfaction survey patients and caregivers, comparing both study groups. | outcome measure: satisfaction (very satisfied, satisfied, unsatisfied, very unsatisfied) | one year | 
| Compare the quality of life of patients by measuring EQ-5D in study groups | outcome measure: EQ-5D questionnaire | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: fibrinogen (g/L) | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: leukocytes (mil/mm3) | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: eosinophils (mil/mm3) | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: pro-BNP (pg/ml) | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: cholesterol (mg/dL) | one year | 
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: proteins (mg/dL) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, hospitalization, telemedicine platform