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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group intervention | Experimental | Conventional management for COPD will take place in our health care system more telematics intervention. |
|
| Group control | Active Comparator | Is performed only conventional management of COPD in our health care system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | outcome measure: incremental cost-effectiveness ratio (ICER) between these two arms | one year |
| Compare the quality of life of COPD patients by measuring CAT in study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Corral, MD | Hospital San Pedro de Alcántara. Cáceres. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaime Corral Peñafiel | Cáceres | 10005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20335383 | Background | 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. | |
| 19648525 | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
|
outcome measure: quality of life measured by CAT questionnaire |
| one year |
| To study the evolution of lung function in both groups after 1 year of follow up. | outcome measure: lung function by spirometry (FEV1/FVC, FVC, FEV1) | one year |
| Analyze the survival at 12 months follow-up in each group. | outcome measure: number of deaths in each group to see the survival in this study | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: PCR (mg/L) | one year |
| Analyze the inhaler compliance and adherence of treatment in both groups. | outcome measure: Morisky-Green´s scoring | one year |
| Make satisfaction survey patients and caregivers, comparing both study groups. | outcome measure: satisfaction (very satisfied, satisfied, unsatisfied, very unsatisfied) | one year |
| Compare the quality of life of patients by measuring EQ-5D in study groups | outcome measure: EQ-5D questionnaire | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: fibrinogen (g/L) | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: leukocytes (mil/mm3) | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: eosinophils (mil/mm3) | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: pro-BNP (pg/ml) | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: cholesterol (mg/dL) | one year |
| Analyze a biomarker predictor of exacerbation severity. | outcome measure: proteins (mg/dL) | one year |
| 20571731 | 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. |
| 12622605 | 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. |
| 23089685 | 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. |
| 18336693 | 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. |
| 21037270 | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |