NCT03018717

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Telemonitoring Constant	telemedicine of Constant
OTHER	Standard clinical care	The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)

Timeline

• Start date: 2016-06-13
• Primary completion: 2018-09-26
• Completion: 2019-09-13
• First posted: 2017-01-12
• Last updated: 2019-06-19

Locations

5 sites across 1 country: Spain