Clinical trial NCT03018717: Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases
Official title: Randomized Multicenter Clinical Trial of a Integral Clinical Care Plan Shared With or Without Telemonitoring of Bio Constants in Patients With Chronic Diseases in Advanced Stages. ATLANTIC Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Lung Disease
Chronic Heart Disease
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Telefónica S.A.
name: Junta de Andalucia
name: Salud Responde
First posted: 2017-01-12
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Six month
Secondary outcomes:
measure: Number of hospital admissions
timeFrame: six month
measure: Safety by monitoring of adverse events and adverse clinical events related to the two arms of the clinical trial
timeFrame: six month
measure: quality of life related to health, of follow-up in both arms of the clinical trial,
timeFrame: At the time of inclusion, at 45 days and after 6 months of follow-up.
measure: quality of care and satisfaction perceived by the subjects in the two arms of the clinical trial.
timeFrame: at 45 days and after 6 months of follow-up
measure: perceived quality and satisfaction with the technological instruments by the subjects in the two arms of the clinical trial.
timeFrame: at 45 days and after 6 months of follow-up,
measure: primary cost-effectiveness of the arm TELEPAC with respect to the arm PAC, using the incremental cost method.
timeFrame: six month
measure: To analyze the secondary incremental cost-effectiveness of the TELEPAC arm with respect to the PAC arm.
timeFrame: six month
measure: Number of admissions-visits to Hospital Emergency
timeFrame: six month
measure: Number of visits to Primary Care Emergencies
timeFrame: six month
measure: mortality
timeFrame: six month
measure: Number of days of hospital stay
timeFrame: six month
measure: Overall cost for patients in euros
timeFrame: six month
Other outcomes:
Locations:
city: Ronda
country: Spain
facility: Serranía de Ronda Hospital
state: Málaga
city: Sevilla
country: Spain
facility: Universitary Hospital Virgen Macarena
state: Seville
city: Sevilla
country: Spain
facility: Universitary Hospital Virgen del Rocío
state: Seville
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
Study officials:
References: