COPD Clinical Trial
— PROMETEOfficial title:
Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).
NCT number | NCT02499068 |
Other study ID # | PROMETE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | June 1, 2016 |
Verified date | August 2019 |
Source | Fundación Teófilo Hernando, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to verify the clinical effectiveness of a managed home
telemonitoring program in patients with severe COPD against usual clinical practice, as
measured by the decrease in the number of exacerbations, number of hospitalizations, hospital
days and emergency room visits in a 12 month period
The primary endpoint of effectiveness is "severe exacerbations avoided."
The main hypothesis is that patients with severe or very severe COPD patients managed with a
home telehealth program have better outcomes than patients managed according to usual
clinical practice.
Status | Completed |
Enrollment | 237 |
Est. completion date | June 1, 2016 |
Est. primary completion date | June 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Being over 50 and under 90 years of age. - Being diagnosed with COPD according to the criteria of GesEPOC, with severe airflow obstruction defined as a forced expiratory volume in one second (FEV1) less than 50% of theoretical. - "Exacerbator phenotype" defined as COPD patients having two or more moderate or severe exacerbations per year (GesEPOC guide). These exacerbations should be separated by at least 4 weeks after the end of previous treatment or 6 weeks from the start in cases that have not been treated - Clinically stable condition, defined as 6 weeks without clinical symptoms since the last exacerbation of COPD. - Having home oxygen therapy. - Sign the informed consent. Exclusion Criteria: - Inability of the patient or caregiver to understand the procedure of Telehealth program. - Have a life expectancy of less than one year. - Have terminal heart failure (NYHA functional class III-IV). - Having advanced renal insufficiency (creatinine clearance <30%) or be on dialysis program. - Have liver cirrhosis or be included in a program of liver transplantation. - Be institutionalized or in Residential hospice care. - Having a mini-mental test-score less than 24, because this score suggests dementia - To be considered by your doctor as not comply the treatment or monitoring required by their lung disease. - Failure to meet any of the inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario La Princesa | Madrid | |
Spain | Hospital Universitario Rey Juan Carlos | Madrid |
Lead Sponsor | Collaborator |
---|---|
Arturo Garcia | Linde Health Care, Syreon Corporation, Técnicas Avanzadas de Investigación en Servicios de Salud TAISS |
Spain,
Segrelles Calvo G, Gómez-Suárez C, Soriano JB, Zamora E, Gónzalez-Gamarra A, González-Béjar M, Jordán A, Tadeo E, Sebastián A, Fernández G, Ancochea J. A home telehealth program for patients with severe COPD: the PROMETE study. Respir Med. 2014 Mar;108(3):453-62. doi: 10.1016/j.rmed.2013.12.003. Epub 2013 Dec 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of hospitalizations due to exacerbation of COPD avoided | 1 year | ||
Secondary | Cost-efficiency of treatment | 1 year | ||
Secondary | Cost-utility of treatment | 1 year | ||
Secondary | satisfaction of both patients and clinician responsibility questionnaire | 1 year |
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