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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: health care system; Device: Group intervention

• Registration Number: NCT03505138
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-05
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-23
• Study Start: 2018-05-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 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.
2. Age over 18 years
3. The patient or caregiver should be able to use the tablet type telematic tool for tracking and monitoring.

Exclusion Criteria

1. Patients with severe comorbidity grade IV heart failure, renal failure on hemodialysis or active neoplasia
2. Patients with difficulties phone coverage
3. Patients with lack of adequate social and family support.
4. Patients who do not grant informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group control	health care system	Is performed only conventional management of COPD in our health care system.
Group intervention	Group intervention	Conventional management for COPD will take place in our health care system more telematics intervention.

Primary Outcome Measures

Name	Time	Method
Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.	one year	outcome measure: the rate of readmissions during the study

Secondary Outcome Measures

Name	Time	Method
Make satisfaction survey patients and caregivers, comparing both study groups.	one year	outcome measure: satisfaction (very satisfied, satisfied, unsatisfied, very unsatisfied)
Compare the quality of life of COPD patients by measuring CAT in study groups	one year	outcome measure: quality of life measured by CAT questionnaire
Analyze the survival at 12 months follow-up in each group.	one year	outcome measure: number of deaths in each group to see the survival in this study
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.	one year	outcome measure: incremental cost-effectiveness ratio (ICER) between these two arms
To study the evolution of lung function in both groups after 1 year of follow up.	one year	outcome measure: lung function by spirometry (FEV1/FVC, FVC, FEV1)
Analyze a biomarker predictor of exacerbation severity.	one year	outcome measure: proteins (mg/dL)
Analyze the inhaler compliance and adherence of treatment in both groups.	one year	outcome measure: Morisky-Green´s scoring
Compare the quality of life of patients by measuring EQ-5D in study groups	one year	outcome measure: EQ-5D questionnaire

Trial Locations

Locations (1)

Jaime Corral Peñafiel; 🇪🇸 Cáceres, Spain