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

NCT03018717 | Unknown

• 1 other identifier: ATLAN_TIC01
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Lung Disease; Chronic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Monitoring number of hospitalizations and/or number of emergency visits in the period.

  Six month

Secondary Outcomes (12)

• 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

• 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.

• 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

• 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,

Study Arms (2)

Tele-monitoring Constant

OTHER

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.

Other: Telemonitoring Constant

Standard clinical care

OTHER

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

Other: Standard clinical care

Interventions

Telemonitoring Constant OTHER

telemedicine of Constant

Tele-monitoring Constant

Standard clinical care OTHER

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

Standard clinical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead
• Telefónica S.A.: collaborator
• Junta de Andalucia: collaborator
• Salud Responde: collaborator

Study Sites (5)

Serranía de Ronda Hospital

Ronda, Málaga, 29400, Spain

Location

Universitary Hospital Virgen Macarena

Seville, Seville, 41009, Spain

Location

Universitary Hospital Virgen del Rocío

Seville, Seville, 41013, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario de Valme

Seville, 41014, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 12, 2017
• Study Start: June 13, 2016
• Primary Completion: September 26, 2018
• Study Completion: September 13, 2019
• Last Updated: June 19, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)