Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases
- Conditions
- Chronic Lung DiseaseChronic Heart Disease
- Interventions
- Other: Telemonitoring ConstantOther: Standard clinical care
- Registration Number
- NCT03018717
- Lead Sponsor
- Fundación Pública Andaluza Progreso y Salud
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 510
- Majority legal age (18 years of age or older)
- Present any of the following shortcomings:
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.
- Present Heart Failure or Respiratory Insufficiency with basal dyspnea grade <III (according to NYHA and MRC respectively) but have presented 2 or more income in the last year.
- Score of Patients with terminal or palliative medical diseases (score PALIAR) index between 0 and 7 points.
- To present one of the following assistance situations: hospital admission, follow-up in Home Hospitalization or Palliative Care Teams, specialized outpatient follow-up.
- Speak, understand, read and write Spanish, either the patient or the primary caregiver.
- Have basic knowledge of the use of mobile phones and applications of computer tablets (such knowledge will be confirmed by personal interview, with test of the device).
- Informed consent to participate in the study
- Presence of malignant neoplastic disease ACTIVE except localized adenocarcinoma of prostate in hormonal treatment, and / or cutaneous basocellular-squamous cell carcinoma.
- In the case of Chronic Renal Disease if there is the possibility of entry into Substitutive Therapies (hemodialysis or transplantation)
- In the case of chronic liver disease, if there is a possibility of liver transplantation.
- Chronic neurological disease with established cognitive impairment (E. Pfeiffer with 7 or more errors and / or Mild cognitive evaluated (ECM with ≤18 points).
- Clinical situation of agony.
- Surprise question ("Would you be surprised if your patient died in the next 6 months?") With the result "I would not be surprised" + PALIAR Score Score ≥7.5 points.
- Participate in another tele-health initiative.
- Go simultaneously to a private health service and / or be institutionalized
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele-monitoring Constant Telemonitoring Constant 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 Standard clinical care 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
- Primary Outcome Measures
Name Time Method 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 Six month Monitoring number of hospitalizations and/or number of emergency visits in the period.
- Secondary Outcome Measures
Name Time Method mortality six month Number of hospital admissions six month perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial. at 45 days and after 6 months of follow-up, Using the Perceived quality for technical support (TSUQ) standardized questionnaire adapted
quality of life related to health, of follow-up in both arms of the clinical trial, At the time of inclusion, at 45 days and after 6 months of follow-up. Using a standardized Using a standardized questionnaire of quality of live related to health in adults (EQ-5D) adapted to Spanish.
To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm. six month using each of the secondary efficacy variables as unit of cost and each patient's overall cost unit.
Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial six month 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.
Overall cost for patients in euros six month quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial. at 45 days and after 6 months of follow-up Using the standardized questionnaire Service Performance (SERVPERF) adapted to health.
primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method. six month using each of the patients that did not require hospital admission and / or emergency visits, as a unit of cost Of each patient.
Number of admissions-visits to Hospital Emergency six month Number of visits to Primary Care Emergencies six month Number of days of hospital stay six month
Trial Locations
- Locations (5)
Serranía de Ronda Hospital
🇪🇸Ronda, Málaga, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Universitary Hospital Virgen del Rocío
🇪🇸Sevilla, Seville, Spain
Hospital Universitario de Valme
🇪🇸Sevilla, Spain
Universitary Hospital Virgen Macarena
🇪🇸Sevilla, Seville, Spain