DiSC-ELEVEN: Digital Sickle Cell Disease Data Platform and Wearable

  • Research type

    Research Study

  • Full title

    DiSC-ELEVEN (Digital Sickle Cell - Evaluating Live Evidence in Vaso-occlusive Crisis and End organ damage prevention & interventioN): Benefits of a Digital Data Platform and Wearable Device in Disease Management, Patient Experience, and Clinical Outcomes

  • IRAS ID

    288780

  • Contact name

    Orlando Agrippa

  • Contact email

    orlando@draperanddash.com

  • Sponsor organisation

    Draper & Dash Ltd

  • ISRCTN Number

    ISRCTN16126140

  • Duration of Study in the UK

    1 years, 6 months, 1 days

  • Research summary

    ‘Implementation of a unified digital data platform and Sickle Cell Disease specific wearable device in improving patient experiences, quality of life and outcomes.’

    The current understanding of Sickle Cell Disease's (SCD) full natural history and the available treatment options for patients fall far behind that of many other diseases with a similar prevalence. Patient care is impacted by limitations around the data available to their clinicians outside of infrequent contacts with treatment centres, meaning the standard of care and speed at which it can be delivered is frequently lacking.

    The key research question therefore addresses how implementation of a unified SCD digital data platform and wearable device may improve patient experiences and outcomes, through better monitoring of key metrics around pain crises and severe complications of the disease. These will be tracked through a combination of hospital and GP medical records, genetic information, as well as real-time data collected from the wearable devices. By combining these into a complete digital patient profile, the aim is to provide patients and clinicians with better insight into how the disease is progressing, which interventions have worked well in historic cohorts in order to drive improved future treatment pathways, and predictive capabilities informing when a patient may be at risk of crises or severe end-organ pathologies.

    Any patient with a known history/diagnosis of SCD, with consent from their parent or guardian from 5-15 years of age, or with the ability and willingness to provide written Informed Consent from 16 years of age, will be eligible to participate.

    The study will be conducted remotely, patients participating in initial pre-study focus groups virtually, and utilising both the digital data platform and wearable from their own homes. The trial of the platform will be ongoing - the wearable device worn daily by patients - over a 12-month trial.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    20/LO/1121

  • Date of REC Opinion

    28 Oct 2020

  • REC opinion

    Unfavourable Opinion