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

March 6, 2019 updated by: Jaime Corral Penafiel, Sociedad Española de Neumología y Cirugía Torácica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cáceres, Spain, 10005
        • Jaime Corral Peñafiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group intervention
Conventional management for COPD will take place in our health care system more telematics intervention.
Device: Group intervention

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.

Other Names:
  • Telematic intervention
Active Comparator: Group control
Is performed only conventional management of COPD in our health care system.
Other: health care system

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.

What is the study measuring?

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.
Time Frame: one year
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.
Time Frame: one year
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
Time Frame: one year
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.
Time Frame: one year
outcome measure: lung function by spirometry (FEV1/FVC, FVC, FEV1)
one year
Analyze the survival at 12 months follow-up in each group.
Time Frame: one year
outcome measure: number of deaths in each group to see the survival in this study
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: PCR (mg/L)
one year
Analyze the inhaler compliance and adherence of treatment in both groups.
Time Frame: one year
outcome measure: Morisky-Green´s scoring
one year
Make satisfaction survey patients and caregivers, comparing both study groups.
Time Frame: one year
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
Time Frame: one year
outcome measure: EQ-5D questionnaire
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: fibrinogen (g/L)
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: leukocytes (mil/mm3)
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: eosinophils (mil/mm3)
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: pro-BNP (pg/ml)
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: cholesterol (mg/dL)
one year
Analyze a biomarker predictor of exacerbation severity.
Time Frame: one year
outcome measure: proteins (mg/dL)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Investigators

  • Principal Investigator: Jaime Corral, MD, Hospital San Pedro de Alcántara. Cáceres. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRONEX3.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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