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Integral Clinical Plan Shared With or Without Telemonitoring of Constants in Patient With Chronic Diseases

NCT03018717 — Not applicable, Unknown, 510 participants, Fundación Pública Andaluza Progreso y Salud

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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

RegistryNCT03018717, acronym ATLAN_TIC01
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment510 (Actual)
SponsorFundación Pública Andaluza Progreso y Salud (Other); collaborators: Telefónica S.A., Junta de Andalucia, Salud Responde
ConditionsChronic Lung Disease, Chronic Heart Disease
InterventionsTelemonitoring Constant, Standard clinical care (Other)
Datesstart 2016-06-13, primary completion 2018-09-26, completion 2019-09-13 (estimated), first posted 2017-01-12, last updated 2019-06-19
Locations5 sites in Spain

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Tele-monitoring ConstantOtherOther: Telemonitoring ConstantTo 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 careOtherOther: Standard clinical careStandard 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
  • Telemonitoring Constant (Other): telemedicine of Constant
  • Standard clinical care (Other): The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Number of hospital admissions [six month]
  • 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.
  • 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.
  • 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]

+Eligibility

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

+Locations (5)

FacilityCityCountryStatus
Serranía de Ronda HospitalRonda, MálagaSpain
Universitary Hospital Virgen MacarenaSeville, SevilleSpain
Universitary Hospital Virgen del RocíoSeville, SevilleSpain
Complejo Hospitalario de JaénJaénSpain
Hospital Universitario de ValmeSevilleSpain

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