Chronic Lung Disease, Chronic Heart Disease
Conditions
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.
Interventions
OTHERTelemonitoring Constant
telemedicine of Constant
The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)
Sponsors
Telefónica S.A.
Junta de Andalucia
Salud Responde
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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 hospital admissions | 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 | — |
| 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. |
Countries
Spain
Outcome results
None listed