Study Details

• Type: Interventional
• Disease: HIV/AIDS (PLWHA)
• Primary Site: Fondazione Policlinico Gemelli
• Start: 10th January 2021
• Population: 1500 patients
• Duration: 24 months

Study Description

Interface is a pilot study for People living with HIV/AIDS (PLWHA) with stable chronic disease, designed by the Department of Infectious Diseases at the Fondazione Policlinico Gemelli. Gemelli has partnered with Innovation Sprint to use Healthentia as the Clinical platform to offer clinical assistance through an efficient operating model to “follow” the patient, capture the evolution of his/her disease, provide assistance and care, interact also to establish proximity and relief through a remote collaborative model.

At the same time, a standardized approach to translate the huge amount of data collected on the day-to-day experience, integrated with historical health data, into useful insight and medical practices based on experience and lessons learned has been built up. People living with HIV/AIDS (PLWHA) represent a typology of patients for whom telemedicine could, particularly in pandemic times, represent an extremely useful tool of support and clinical management, quickly identifying potential sources for spreading of SarS-CoV2 diffusion and transmission among potentially high-risk population such as PLWHA.

Study Design & Method

People living with HIV today are people who have a life expectancy very similar to that of the general population, due to the extraordinary effect that antiretroviral therapies have produced on survival and on the reduction of HIV-related morbidity. Nowadays PLWHA patients face a chronic condition with all the consequences that this situation entails (symptoms, side effects of the drugs, management of adherence and quality of life, periodic supply of drugs, blood samples to check the tolerability of the drugs, any new clinical events that may occur, need advice from other specialists, etc.). With the persisting of pandemic restrictions, it is essential to find ways of managing these patients remotely to allow continuity of care that will inevitably not reflect what happened in pre-epidemic periods.

Capture the evolution of the disease and establish proximity and relief through a remote collaborative model

The daily patient experience, integrated with the historical patient health data, is translated into useful insights and experience for medical practices

Testimonial

"It will be a sort of 'virtual clinic', which will allow us to demedicalize the life of the chronic patient with HIV as much as possible, maintaining close contact even when face-to-face visits are impossible, with an 'on demand' web meetings in case of the appearance of physical symptoms or psychological problems, which in this phase of the pandemic can have a significant impact on the quality of life of people with HIV.", Dr. Antonella Cingolani, Department of Infectious Diseases of the Gemelli Polyclinic

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Study Details

• Type: Interventional
• Disease: Covid19 Surveillance of Oncology patients and Hospital personnel
• Primary Site: Fondazione Policlinico Gemelli
• Start: March 2020
• Population: Incoming patients and personnel
• Duration: Ongoing

Study Description

TRACER RT is an interventional study introducing a new operational model for the monitoring and early diagnosis of COVID-19 infection in healthcare professionals and patients during multimodal therapies and the follow-up period through the use of Healthentia as a dedicated App and wearable technologies. The primary aim is to introduce Oncology patients with the use of portable monitoring systems such as Patient Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROMs) by means of a dedicated app and even a tracking device as Electronic Health Record data harvesting devices, during their multimodal therapies and follow-up period.

Study Design & Method

The application will be used by patients during radiotherapy (RT) or in the first phase of follow-up and healthcare workers of the RT division, with the aim of monitoring the earlier symptoms of SARS-COV-2 infection. After the SARS-COV-2 emergency, the app will be used to monitor patients during and after radiotherapy with a special focus on supportive care and oncological rehabilitation.
Daily, weekly and monthly questionnaires are collecting data to be assessed by Healthentia and alert low or high risk of a Covid-19 infection.

Reduce risk of Infection in the Radiotherapy Department

Oncology patients and Hospital personnel surveillance for COVID-19 Symptom appearance

Testimonial

“Monitoring patients during multimodal therapies or during special situations such as SARS-COV-2 infection may represent a significant step towards a comprehensive and reliable therapy approach, quality of life assessment, prevention of complications before its clinical onset, and clinical outcomes prediction.”
Dr. Luca Tagliaferri, Department of Radiotherapy and Oncology

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Study Details

• Type: Interventional
• Disease: Covid19 Surveillance on Hospital personnel
• Primary Site: Fondazione Policlinico Gemelli
• Start: January 2021
• Population: Personnel
• Duration: Ongoing

Study Description

VACCINE APP is a study to record and monitor the personnel of the Agostino Gemelli IRCCS University Hospital Foundation after the administration of the first dose of vaccine. After downloading the application on the smartphone and registering, the user is asked to report any side effects that occurred on the day of vaccination and the next seven days, through a questionnaire. Healthentia collects real-world data (RWD) from each user and any reactions experienced on the day of vaccination and in the following days, through an agile questionnaire.

Study Design & Method

The application will be used by the personnel of the Agostino Gemelli IRCCS University Hospital Foundation to monitor their health status after the first dose of the COVID-19 vaccine. There is a composite questionnaire in the Healthentia application with a series of tags and alerts, which will be activated in case of any vaccine reaction.

Monitoring possible adverse events, through a series of real self-reported data

Hospital personnel surveillance for post-vaccination symptoms of COVID-19

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Study Details

• Type: Interventional
• Disease: Covid 19 Surveillance of positive tests
• Primary Site: Fondazione Policlinico Gemelli
• Start: February 2021
• Population: Outpatient pulmonary adults with documented positive SARS-CoV-2 test
• Duration: Ongoing

Study Description

MONET study is a Phase 3, open-label, individually randomized study in patients with documented positive SARS-CoV-2 test and mild symptoms of COVID-19, not hospitalized and recruited in Italy. This study will assess the efficacy of multiple MoAbs cocktails compared to SoC for Treatment of COVID-19 in Outpatient Adults. The study will be conducted in 42 clinical centers across Italy.

Study Design & Method

The procedure to be followed is the randomized administration of 2 different MoAbs cocktails, all intravenously over one-hour infusion. Then there will be control and monitoring of the differences that will occur in the participants of the study. The adaptive design of the study is aimed to meet the most topical needs of translational medical research programs implemented during a massive epidemic emergency due to newly emergent pathogens, such as SARS-CoV-2.

All participants will use the Healthentia app to answer simple and composite questionnaires about their health status. Each organisation will monitor any symptoms that any user/participant may appear.

42 Centers involved in the study and is planned to be executed on 750 to 2350 subjects

Estimation of the efficacy of any MoAbs in the prevention of the composite endpoint of either severe COVID-19 or hospitalization or access in an emergency department or death

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Study Details

• Type: Multicentric
• Disease: Covid 19 Surveillance of positive tests
• Primary Site: Fondazione Policlinico Gemelli
• Start: March 2021
• Population: Outpatient pulmonary adults with documented positive SARS-CoV-2 test
• Duration: Ongoing

Study Description

IPF VACCINE is a study to record and monitor Idiopathic pulmonary fibrosis (IPF) patients of the Agostino Gemelli IRCCS University Hospital Foundation after the administration of their vaccination. Healthentia application will be used to collect through questionnaires, any side effects that occurred on the day of vaccination and the following seven days.

Study Design & Method

All participants will download Healthentia application and register. For a period of 7 days, the user is asked, through an agile questionnaire, to report any side effects that occurred on the day of vaccination and the next seven days.

Monitor reactions on IPF Patients

Categorize side effects present in
IPF Patient group

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