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

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ClinicalTrials.gov Identifier: NCT03505138
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jaime Corral Penafiel, 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.


Condition or disease Intervention/treatment Phase
COPD Device: Group intervention Other: health care system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Telemedicine in the Rate of Readmission for COPD and Cost-effectiveness Analysis (e- Pneumo ) : Project CRONEX 3.0
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : February 1, 2019

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 Name: 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505138


Locations
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Spain
Jaime Corral Peñafiel
Cáceres, Spain, 10005
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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Principal Investigator: Jaime Corral, MD Hospital San Pedro de Alcántara. Cáceres. Spain

Publications:

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Responsible Party: Jaime Corral Penafiel, Medical Doctor, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT03505138     History of Changes
Other Study ID Numbers: CRONEX3.0
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jaime Corral Penafiel, Sociedad Española de Neumología y Cirugía Torácica:
COPD
hospitalization
telemedicine platform