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| Name | Class |
|---|---|
| Telefónica S.A. | INDUSTRY |
| Junta de Andalucia | OTHER_GOV |
| Salud Responde | UNKNOWN |
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Information and communications technologies (ICT) currently constitute a key element in the innovation and improvement of providing health-care to frail populations with advanced chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven conclusively. The investigators are going to carry out a multi-center, randomized, parallel groups, phase III clinical trial in adult patient with heart and/or lung advanced diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of bio-parameters added to optimal standard of clinical care (shared clinical care plan) compared to the shared clinical care plan exclusively.
a total number of 510 patients will be divided in 3 centers: Hospital University Virgen del Rocío; Hospital University Virgen Macarena and Public Hospital Comarcal of Serranía de Ronda. Patient will be randomized in Tele-monitoring Constant (TELEPAC) To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan or in Standard Clinical Care (PAC) based on a comprehensive clinical assistance shared between Primary Care and Hospital Care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-monitoring Constant | Other | To analyze the efficacy and cost-efficacy of incorporating tele-monitoring of bio-parameters into the shared comprehensive clinical care plan. Patients will receive in their home a kit consisting of a briefcase containing all equipment (scale, pulse-oximeter ... etc) and a logo access to devices (Tablet) through mobile communications m2m between patient and platform Management for Chronic Patients. |
|
| Standard clinical care | Other | Standard clinical care plan shared between plan of attention to the patient with Pluri-pathological process and the care plan for patients with chronic diseases, based on a comprehensive clinical assistance shared between Primary Care and Hospital Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring Constant | Other | telemedicine of Constant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce the number of hospital admissions and / or the number of hospital emergency visits and / or the number of primary care visits of the patients in the TELEPAC arm (patients with tele-monitoring) with respect to the PAC arm (patient without tele-Moni | Monitoring number of hospitalizations and/or number of emergency visits in the period. | Six month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital admissions | six month | |
| Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial | analyze the safety of the two arms by monitoring the number of adverse events and adverse clinical events related to the two arms of the clinical trial. |
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Inclusion Criteria:
Heart failure with baseline dyspnea ≥III of New York Heart Association (NYHA) Chronic respiratory insufficiency with basal dyspnea ≥III of Medical Research Council (MRC) Scale and / or oxygen saturation <90% and / or home oxygen therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Serranía de Ronda Hospital | Ronda | Málaga | 29400 | Spain | ||
| Universitary Hospital Virgen Macarena |
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| Standard clinical care |
| Other |
The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes) |
|
| six month |
| quality of life related to health, of follow-up in both arms of the clinical trial, | Using a standardized Using a standardized questionnaire of quality of live related to health in adults (EQ-5D) adapted to Spanish. | At the time of inclusion, at 45 days and after 6 months of follow-up. |
| quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial. | Using the standardized questionnaire Service Performance (SERVPERF) adapted to health. | at 45 days and after 6 months of follow-up |
| perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial. | Using the Perceived quality for technical support (TSUQ) standardized questionnaire adapted | at 45 days and after 6 months of follow-up, |
| primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method. | using each of the patients that did not require hospital admission and / or emergency visits, as a unit of cost Of each patient. | six month |
| To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm. | using each of the secondary efficacy variables as unit of cost and each patient's overall cost unit. | six month |
| Number of admissions-visits to Hospital Emergency | six month |
| Number of visits to Primary Care Emergencies | six month |
| mortality | six month |
| Number of days of hospital stay | six month |
| Overall cost for patients in euros | six month |
| Seville |
| Seville |
| 41009 |
| Spain |
| Universitary Hospital Virgen del Rocío | Seville | Seville | 41013 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital Universitario de Valme | Seville | 41014 | Spain |