Covid-19
In response to COVID-19, Huma has configured a decentralised clinical trial solution focused on remote data capture. This includes e-consent, ePRO collection, biometric capture, wearables, and telemedicine/virtual visits. This out-of-the-box solution can be deployed in 15 days and is easily integrable into other systems.
Functionality
Participant App: Remote participant data capture with in-built e-consent and telemedicine created on an infrastructure allowing for tailoring of assessments to study protocol. Integrates wearables and houses educational content for improved participant engagement.
Site Dashboard: Web-based analytics dashboard accessible by research teams to visualise participant data generated from the Huma app in real-time. Includes communication with participants directly via telemedicine, monitoring of deterioration and adverse events with automatic flagging system based on configurable thresholds.
of deterioration and adverse events with automatic flagging system based on configurable thresholds.
Integrated devices: We have integrated a portfolio of over 400 external wearables and connected devices to enable seamless data capture, whilst establishing partnerships with device manufactures to deliver deployment at scale.
How it works
In-built e-consent functionality allowing participants to be fully informed prior to trial initiation and support remote on-boarding.
Ability for the participant to receive virtual clinical visits for continued remote engagement & secure communication within the app.
Medication list with dosage/frequency, remote titration through the portal and adherence assessment with insight into factors for non-compliance.
Dissemination of clinical trial content to maximise engagement and reduce dropout rate (e.g. current advice, trial details, mental health, etc).
A single, points-based measure of overall health captured using only a smartphone. Clinically validated with data from half a million people over 10+ years. Developed with KOLs from Johns Hopkins, Harvard, Imperial College London and more.
Create bespoke questionnaire or digitise validated ePRO measures
In-app data through utilisation of built-in phone sensors (eg camera PPG for HR, HRV, rhythm assessment) and/or 3rd party device integration for active and passive biometric collection.
In-built e-consent functionality allowing participants to be fully informed prior to trial initiation and support remote on-boarding.
A single, points-based measure of overall health captured using only a smartphone. Clinically validated with data from half a million people over 10+ years. Developed with KOLs from Johns Hopkins, Harvard, Imperial College London and more.
Ability for the participant to receive virtual clinical visits for continued remote engagement & secure communication within the app.
Create bespoke questionnaires or digitise validated ePROM measures.
Medication list with dosage/frequency, remote titration through the portal and adherence assessment with insight into factors for non-compliance.
In-app data through utilisation of built-in phone sensors (eg camera PPG for HR, HRV, rhythm assessment) and/or 3rd party device integration for active and passive biometric collection.
Dissemination of clinical trial content to maximise engagement and reduce dropout rate (e.g. current advice, trial details, mental health, etc).
Database
One of the benefits of virtual clinical trials with Huma is our web-based data dashboard. It provides a comprehensive overview of data points that include: individual participant data and progress, functionality for tele-medicine visits, symptom and side effect tracking, rules-based prioritisation, and researcher data entry.
All data is securely hosted on AWS cloud and can be exported to meet study database requirements.
Compatible with
Pathways
Remote on-boarding through SMS or e-mail link. In-app screening questionnaire to establish eligibility and data baseline.
List of all on-boarded patients with prioritisation of those that are eligible.
Remote collection of e-consent in app. Study information and instructions provided during consent process.
Consent record logged in database.
Participant follows set of pre-determined activities for active and passive data collection. App dashboard allows individual patient insight (but can also be blinded)
Site dashboard logs in real-time all participant data input including data extraction from Apple Health and Google Fit. Individual patient records allow for trend visualisation and comparison of multiple data points.
In-app notifications provide reminders of activities to complete/data to enter. Activity schedules are created in accordance with the study protocol.
Participants are visually prioritised according to pre-determined metrics (e.g. engagement, deterioration, side effects).
In-app virtual telemedicine visits allow for secure and easy remote communication with research team.
In-portal virtual telemedicine visits allow for secure and easy remote communication with participants.
Case study: Digital Biomarker
RAVLT 2.0
In partnership with Johnson & Johnson, we are commercialising and further validating a digital biomarker focussed on early detection of Alzheimer's disease through assessing verbal episodic memory via voice recognition technology. The biomarker enables entire populations to be screened for early cognitive decline, enhancing strategic health population management.
J&J have chosen Huma as their partner due to our experience in digital health development, the APAC market, and biomarker validation engine. Using our reach and globalisation platform, the digital biomarker will be further validated for use in Mandarin, and subsequently commercialised globally.
CASE STUDY
Our experience in COVID-19
Huma’s RPM for population health management allows patients to remain at home under the supervision of their care team. This reduces unnecessary travel and exposure to others, and eases the burden on healthcare providers who are at capacity.
Care teams are able to configure thresholds for alerts and use the flagging system to identify COVID-19 patients’ health deterioration or improvement, adjusting care plans accordingly.
