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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
510
telemedicine of Constant
The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)
Serranía de Ronda Hospital
Ronda, Málaga, Spain
Universitary Hospital Virgen Macarena
Seville, Seville, Spain
Universitary Hospital Virgen del Rocío
Seville, Seville, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario de Valme
Seville, Spain
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.
Time frame: Six month
Number of hospital admissions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: six month
Number of admissions-visits to Hospital Emergency
Time frame: six month
Number of visits to Primary Care Emergencies
Time frame: six month
mortality
Time frame: six month
Number of days of hospital stay
Time frame: six month
Overall cost for patients in euros
Time frame: six month
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