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

NCT03505138 | Completed

• 1 other identifier: CRONEX3.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; hospitalization; telemedicine platform

Outcome Measures

Primary Outcomes (1)

• Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.

  outcome measure: the rate of readmissions during the study

  one year

Secondary Outcomes (14)

• 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

• Compare the quality of life of COPD patients by measuring CAT in study groups

  one year

• To study the evolution of lung function in both groups after 1 year of follow up.

  one year

• Analyze the survival at 12 months follow-up in each group.

  one year

• Analyze a biomarker predictor of exacerbation severity.

  one year

Study Arms (2)

Group intervention

EXPERIMENTAL

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

Device: Group intervention

Group control

ACTIVE COMPARATOR

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

Other: health care system

Interventions

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.

Also known as: Telematic intervention

Group 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.

Group control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Jaime Corral Peñafiel

Cáceres, 10005, Spain

Location

Related Publications (7)

• 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.

  PMID: 20335383 BACKGROUND

• 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.

  PMID: 19648525 BACKGROUND

• 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.

  PMID: 20571731 BACKGROUND

• 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.

  PMID: 12622605 BACKGROUND

• 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.

  PMID: 23089685 BACKGROUND

• 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.

  PMID: 18336693 BACKGROUND

• 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.

  PMID: 21037270 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Delivery of Health Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jaime Corral, MD

  Hospital San Pedro de Alcántara. Cáceres. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: April 23, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2018-04

Locations

ES (1)