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

NCT ID: NCT03505138

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-02-01

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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group intervention

Conventional management for COPD will take place in our health care system more telematics intervention.

Group Type EXPERIMENTAL

Group intervention

Intervention Type 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.

Group control

Is performed only conventional management of COPD in our health care system.

Group Type ACTIVE_COMPARATOR

health care system

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Telematic intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role lead

Responsible Party

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Jaime Corral Penafiel

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Corral, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Pedro de Alcántara. Cáceres. Spain

Locations

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Jaime Corral Peñafiel

Cáceres, , Spain

Site Status

Countries

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Spain

References

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Cosio BG, Agusti A. Update in chronic obstructive pulmonary disease 2009. Am J Respir Crit Care Med. 2010 Apr 1;181(7):655-60. doi: 10.1164/rccm.201001-0111UP. No abstract available.

Reference Type BACKGROUND
PMID: 20335383 (View on PubMed)

Escarrabill J. Discharge planning and home care for end-stage COPD patients. Eur Respir J. 2009 Aug;34(2):507-12. doi: 10.1183/09031936.00146308.

Reference Type BACKGROUND
PMID: 19648525 (View on PubMed)

Hurst JR, Fitzgerald-Khan F, Quint JK, Goldring JJ, Mikelsons C, Dilworth JP, Wedzicha JA. Use and utility of a 24-hour Telephone Support Service for 'high risk' patients with COPD. Prim Care Respir J. 2010 Sep;19(3):260-5. doi: 10.4104/pcrj.2010.00035.

Reference Type BACKGROUND
PMID: 20571731 (View on PubMed)

Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.

Reference Type BACKGROUND
PMID: 12622605 (View on PubMed)

Jurado Gamez B, Feu Collado N, Jurado Garcia JC, Garcia Gil F, Munoz Gomariz E, Jimenez Murillo L, Munoz Cabrera L. Home intervention and predictor variables for rehospitalization in chronic obstructive pulmonary disease exacerbations. Arch Bronconeumol. 2013 Jan;49(1):10-4. doi: 10.1016/j.arbres.2012.08.003. Epub 2012 Oct 22. English, Spanish.

Reference Type BACKGROUND
PMID: 23089685 (View on PubMed)

De Vries B, Darling-Fisher C, Thomas AC, Belanger-Shugart EB. Implementation and outcomes of group medical appointments in an outpatient specialty care clinic. J Am Acad Nurse Pract. 2008 Mar;20(3):163-9. doi: 10.1111/j.1745-7599.2007.00300.x.

Reference Type BACKGROUND
PMID: 18336693 (View on PubMed)

Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26-31. doi: 10.1136/thx.2009.127621. Epub 2010 Oct 30.

Reference Type BACKGROUND
PMID: 21037270 (View on PubMed)

Other Identifiers

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CRONEX3.0

Identifier Type: -

Identifier Source: org_study_id

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