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

NCT ID: NCT03018717

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-13
• Study Completion Date: 2019-09-13

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.

Conditions

Chronic Lung Disease; Chronic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tele-monitoring 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.

Group Type: OTHER

Telemonitoring Constant

Intervention Type: OTHER

telemedicine of Constant

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

Group Type: OTHER

Standard clinical care

Intervention Type: OTHER

The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)

Interventions

Telemonitoring Constant

telemedicine of Constant

Intervention Type: OTHER

Standard clinical care

The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Telefónica S.A.

INDUSTRY

Sponsor Role: collaborator

Junta de Andalucia

OTHER_GOV

Sponsor Role: collaborator

Salud Responde

UNKNOWN

Sponsor Role: collaborator

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Spain

Other Identifiers

ATLAN_TIC01

Identifier Type: -

Identifier Source: org_study_id