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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online telemonitoring group (G_CAARING) | Active Comparator | The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. |
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| Control Group (G_Control) | No Intervention | The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| software Caaring (remote monitoring app) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with al least 80% of data completed | Percentage of patients with al least 80% of data completed in the application. | Week 12 |
| Percentage of patients with 100% of data completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Bravo | Contact | +34915004013 | roberto.bravo@perseivivarium.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario HM Monteprincipe | Recruiting | Boadilla del Monte | Madrid | 28660 | Spain |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Percentage of patients with 100% of data completed in the application
| 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. | 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. | Week 12 |
| Hospital Universitario HM Sanchinarro | Recruiting | Hortaleza | Madrid | 28050 | Spain |
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| Hospital Universitario HM Puerta del Sur | Recruiting | Móstoles | Madrid | 28938 | Spain |
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