The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in cancer patients with a software called Caaring® a través del cumplimento terapéutico y de dosis. The main question it aims to answer is if the development of a self-management platform (Caaring®) empowers cancer patients throughout their illness, reducing the number of in-person and telephone visits assisted by specialized medical and nursing staff. For this, researchers will compare the assessments between the two groups. This is a randomized study with two arms. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Prospective Control group: The data of these patients are collected prospectively for their routine medical visits for 12 weeks after their inclusion. Caaring group patients must have sufficient technological skills to use a smartphone.
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
194
Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/ questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G\_CAARING) will receive educational and prevention recommendations relative to cancer.
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
RECRUITINGHospital Universitario HM Sanchinarro
Hortaleza, Madrid, Spain
RECRUITINGHospital Universitario HM Puerta del Sur
Móstoles, Madrid, Spain
RECRUITINGPercentage of adherence to treatment prescribed for cancer
The Percentage of adherence to treatment prescribed for cancer will be calculed: Units minus unused units, multiplied by 100
Time frame: 12 weeks
Percentage of patients with al least 80% of data completed
Percentage of patients with al least 80% of data completed in the application.
Time frame: Week 12
Percentage of patients with 100% of data completed
Percentage of patients with 100% of data completed in the application
Time frame: Week 12
Changes in the use of health resources
Change in patient´s use of health resources scores al basal monthly and at the end of the study compared to baseline: Number of visits to specialist (e.g. oncology, primary care etc), number of emergency room vistis or number of new hospitalizations.
Time frame: Day 0 and Monthly up to 12 weeks
Patient satisfaction with the software Caaring
The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. Values: 3-15, a higher score refletcs greater satisfaction with software care.
Time frame: Week 12
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