Study Description

HLT_DTM2 is a co-sponsored Study with the University of Thessaly using Healthentia to offer personalized coaching to 30 patients with Type 2 Diabetes. The study consists of a 2-week assessment period followed by a 12 week intervention period with mandatory completion of questionnaires, weight and glucose measurement monitoring and two teleconsultations with a dietician.

Study Details

• Type:  Interventional
• Disease:  Type 2 Diabetes
• Sites: University of Thessaly
• Start:  Phase 1: Jan 2023
• Population: 30 patients
• Duration: 2 + 12-week program

Tamouridis Stefanos MD, MSc

Clinic of Endocrinology and Metabolic Diseases, General University Hospital of Larissa
University of Thessaly

Study Design & Method

Diabetes Type 2 is a chronic and complex disease, with high heterogeneity, wide variation in age of onset, varying degrees of obesity, insulin resistance and a tendency to develop complications. Its management can prevent or delay the onset of complications and maintain patients' quality of life.

The aim of the study is to investigate the effect of the use of a mobile phone application (Healthentia) by patients with DM2, which makes use of a virtual coach, educational and lifestyle interventions, regarding glycemic control, quality of life, as well as body weight and diet parameters of the patients.

Validate the effect of personalized coaching with educational and motivational content to changes in HbA1c values

Demonstrating increased physical activity, reduction in weight and changes in lifestyle habits

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Study Details

• Type: Non-interventional
• Disease: Haemophilia A
• Sites: 20 sites in Italy
• Start: January 2020
• Population: 150 patients
• Duration: 12 months

Study Description

POWER is a multicenter non-interventional study to evaluate the physical activity, bleeding incidence, and Health-related Quality of Life in patients with Haemophilia A without inhibitors receiving the standard of care treatment. the above outcomes will be collected through a Fitbit tracking device and Healthentia ePRO, customized for the purposes of the Study. This study is in partnership with a Clinical Research Organization (CRO) Cros NT and an eCRF technology provider Arithmos Life Sciences for a Top5 Pharma.

Study Design & Method

Patients will receive a Fitbit device (i.e monitoring bracelet) that will collect at a daily basis Real-World Data like activity (i.e. steps per day), sleep, and vital signs. The device will be delivered during the recruitment, a Fitbit account will be opened and the Application The collected data are then transferred to the patient’s paired device through the Healthentia application downloaded on their smartphone.

During the whole observation period, patients will report through dedicated questionnaires sent to the Power App their wellbeing status in scheduled timings or ad hoc reporting of bleeding or adverse events. A quarterly EQ 5D5L questionnaire is assessing the quality of life and monthly a VAS scale is assessing pain intensity. Absences from school/work and hospitalizations. Bleeding events, treatment adherence and doses and frequency of concomitant medicines are reported monthly.

Document physical activity, (active minutes, steps count and MET) by age categories (12-17, 18-30, and 31-50 years) in patients with haemophilia A without inhibitors

Collect information on incidence and severity of adverse events (AEs)

Profile Haemophiliac patients of different categories active vs. sedentary and severe vs. moderate in terms of dif aspects

Evaluate the relationship between physical activity (type and intensity) and bleedings

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Study Details

• Type: Observational
• Disease: Cervical Cancer
• Primary Site: Fondazione Policlinico Gemelli
• Start: October 2020
• Population: 50 patients
• Duration: 24 months

Study Description

APACHE is an observational study with tracking devices, co-financed with a primary aim, to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of the dedicated app Healthentia and wearable technology (i.e. monitoring bracelet), as Electronic Health Record data harvesting devices.

Monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset, and treatment outcomes prediction. More specifically, women affected by locally advanced cervical cancer undergoing chemoradiotherapy followed either by surgery or brachytherapy will report experience measurements like toxicity, instrumental activities of daily living, and stress/coping levels.

The machine learning-assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow-up practices.

Study Design & Method

Patients will receive a state-of -the-art wearable device (i.e monitoring bracelet) that will collect at a daily basis Real-World Data like activity (i.e. steps per day), sleep, and vital signs. The device will be delivered during the first visit prior to CRT start. The collected data are then transferred to the patient’s paired device through the Healthentia application downloaded on their smartphone.

During the whole observation period, patients will be also asked to report their weekly wellbeing through the same application, completing dedicated questionnaires. Patient reported outcomes together with the data coming from the wearable device, are used to create lifestyle behavioral patterns of patient utilizing AI algorithms. Models with neural networks will be afterward trained, making it possible to monitor deviations from the patterns, assess and predict clinical outcomes and help with the validation of therapy efficacy and compliance.

Evaluate patients Quality of Life using portable monitoring technologies during the multimodal oncological therapies and follow up period

Compare patient reported outcomes with corresponding clinical records about toxicity, instrumental activities of daily living (IADLs), and stress/coping levels

Profile patients based on their scores and activity

Train models using AI and machine learning on the patients-reported and monitored data

Testimonial

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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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