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Completed

NCT Number: NCT03505138

Impact of Telemedicine in the Rate of Readmission for COPD. 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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaime Corral Peñafiel

Cáceres, 10005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group intervention

Device

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

health care system

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: PCR (mg/L)

  6. Analyze the inhaler compliance and adherence of treatment in both groups.

    Time frame: one year

    outcome measure: Morisky-Green´s scoring

  7. Make satisfaction survey patients and caregivers, comparing both study groups.

    Time frame: one year

    outcome measure: satisfaction (very satisfied, satisfied, unsatisfied, very unsatisfied)

  8. Compare the quality of life of patients by measuring EQ-5D in study groups

    Time frame: one year

    outcome measure: EQ-5D questionnaire

  9. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: fibrinogen (g/L)

  10. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: leukocytes (mil/mm3)

  11. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: eosinophils (mil/mm3)

  12. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: pro-BNP (pg/ml)

  13. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: cholesterol (mg/dL)

  14. Analyze a biomarker predictor of exacerbation severity.

    Time frame: one year

    outcome measure: proteins (mg/dL)

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 23, 2018
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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