Real World Data

Collection & processing of RWD

Our living habits can be enumerated using data attributes about our lifestyle, obtained in our natural environment, outside of the clinical setting.

This data is termed Real-World Data (RWD) and although it does not provide a detailed understanding of the clinical status of a person, its ubiquitous collection allows a dense description of peoples’ lifestyle. 

Healthentia is collecting several types of RWD and offers advanced AI tools for processing, to derive insights and services, such as synthetic data for control arms. The collected RWD attributes supported are physiological, psychological, social and environmental. 

RWD

Capabilities

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Physiological RWD

The physiological attributes of RWD have to do with the human body, its activities and adverse events. They are mostly measured using activity trackers and/or smartphones but are also reported. Physiological data include activity, sleep, composite tests like the six-minute walk test (6MWT), frailty tests and self-reported symptoms by the participant. Further attributes include nutrition liquid intake and the menstrual cycle.  

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Social RWD

The social RWD attributes enumerate study participants’ social life, such as information that can be measured indirectly using attributes about the usage of the phone (diversity, duration, frequency of calls) and social media (diversity, number, frequency of interactions).  

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Psychological RWD

The psychological RWD attributes refer to the emotions of the study participants and are mostly reported and include at a high-level simple emotional state self-assessment, but when deemed necessary the collected information goes deeper using standardized reports from professional therapists monitoring the patients.  

 

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Environmental RWD

The environmental RWD attributes attempt to enumerate the environment that study participants live in. The weather, the type like urban or residential and the quality of air and pollution.

Formal definition for RWD by the FDA

“Data related to patient health status and/or the delivery of health care routinely collected from EHRs, claims and billing data, data from product and disease registries, patient-generated data including home-use settings, and data gathered from other sources that can inform on health status, such as mobile devices”. 

Healthentia v3 app screens

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Healthentia medical device is a smartphone app for chronic disease patients and a clinical dashboard for healthcare professionals. Healthentia is offering advanced RPM features through its medical modules that empower patients with chronic diseases and contribute to better health outcomes. Its intended purpose includes the collection of physiological data, visualization and trend analysis, transmission of patient outcomes to healthcare providers, and the enabling of personalized interactions through a virtual coach. Further to the RPM features, Healthentia is addressing the root cause of chronic disease, the behavioral risk factors and through personalized virtual coaching, assists patients towards a lifestyle change.

Healthentia is also used for Decentralized Clinical Trials (DCT, leveraging best-of-breed of eClinical studies features, such as eRecruitment, eConsent, teleconsultation/ televisit, ePRO-IoT integration, and virtual coaching. Healthentia empowers patients and gives them an active role in taking trial’s actions, rather than bringing them to the trial sites; thus facilitating clinical trial optimization, accelerating trial processes, reducing drop-out and failure rates, and validating drug/intervention efficacy and effectiveness with Real World Data insights. Healthentia is used by Top5 Pharma and large hospitals and operates under the strict regulatory framework of Good Clinical Practice.