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
| Registry | NCT03018717, acronym ATLAN_TIC01 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 510 (Actual) |
| Sponsor | Fundación Pública Andaluza Progreso y Salud (Other); collaborators: Telefónica S.A., Junta de Andalucia, Salud Responde |
| Conditions | Chronic Lung Disease, Chronic Heart Disease |
| Interventions | Telemonitoring Constant, Standard clinical care (Other) |
| Dates | start 2016-06-13, primary completion 2018-09-26, completion 2019-09-13 (estimated), first posted 2017-01-12, last updated 2019-06-19 |
| Locations | 5 sites in Spain |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tele-monitoring Constant | Other | Other: 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 | Other | Other: 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 |
Sex: All, ages: 18 Years to any
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| Facility | City | Country | Status |
|---|---|---|---|
| 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 |