Clinical trial NCT03505138: Impact of Telemedicine in the Rate of Readmission for COPD. Project CRONEX 3.0
Official title: Impact of Telemedicine in the Rate of Readmission for COPD and Cost-effectiveness Analysis (e- Pneumo ) : Project CRONEX 3.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
hospitalization
telemedicine platform
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Assess whether a telematic program intervention can decrease the rate of readmissions in patients with COPD, comparing with conventional management.
timeFrame: one year
Secondary outcomes:
measure: 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.
timeFrame: one year
measure: Compare the quality of life of COPD patients by measuring CAT in study groups
timeFrame: one year
measure: To study the evolution of lung function in both groups after 1 year of follow up.
timeFrame: one year
measure: Analyze the survival at 12 months follow-up in each group.
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
measure: Analyze the inhaler compliance and adherence of treatment in both groups.
timeFrame: one year
measure: Make satisfaction survey patients and caregivers, comparing both study groups.
timeFrame: one year
measure: Compare the quality of life of patients by measuring EQ-5D in study groups
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
measure: Analyze a biomarker predictor of exacerbation severity.
timeFrame: one year
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: Jaime Corral Peñafiel
Study officials:
affiliation: Hospital San Pedro de Alcántara. Cáceres. Spain
name: Jaime Corral, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.