Patient benefits of a digital data platform for sickle cell disease
| ISRCTN | ISRCTN16126140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16126140 |
| IRAS number | 288780 |
| Secondary identifying numbers | IRAS 288780 |
- Submission date
- 07/09/2020
- Registration date
- 09/09/2020
- Last edited
- 09/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
Sickle cell disease (SCD) is a group of inherited health conditions that affect the red blood cells. The symptoms include painful episodes called sickle cell crises, which can be very severe and last up to a week. The current understanding of SCD's 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.
This study aims to find out whether a unified SCD digital data platform and wearable device improves 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 the disease's natural history, which interventions have worked well to improve future treatment, and inform when a patient may be at risk of crises or severe end-organ pathologies. The work will study vital parameters collected over a long duration within a group of patients with SCD to determine how these relate to acute and chronic illnesses, as well as healthcare utilisation.
Who can participate?
1. Children with sickle cell disease aged 5-15, with consent from and attendance/guidance by parent or legal guardian
2. Adults with sickle cell disease aged 16 and over
What does the study involve?
No interventions or changes to medical treatment will be involved in the study, and all participants will follow the same study protocol.
The study will be conducted remotely, with patients participating in initial pre-study focus groups virtually over video call, in addition to a post-study focus group at the end of the study. The study of the technology will be ongoing, and participants will wear either their own or a study-provided smartwatch during their day-to-day lives, to track their vital parameters on a constant and automated basis. These will include metrics such as heart rate and activity levels. The study will also involve the collation of each participant's hospital and medical GP records alongside this live wearables collected data, within the digital platform. The participant will need only provide informed consent for this, and the study team will manage the data requests and integration.
What are the possible benefits and risks of participating?
There are no direct benefits in terms of changes to treatment or other aspects of participants' care. The results will add to the current knowledge about SCD, potential triggers of pain crises or complications, and individual treatment options. It will provide participants with a greater understanding of their daily health and medical history, including information that they may choose to share with their clinical team to help manage their disease.
No interventions or changes to medical treatment are involved in the study, and the only potential risk will be data security. This has been securely addressed by the study team to ensure strong cybersecurity measures, encryption and two-factor authentication needed to access the digital platform.
Where is the study run from?
London North West University Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
July 2020 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Kim Summers, kim@saniushealth.com
Contact information
Public, Scientific
Sanius Health
One Canada Square
Canary Wharf
London
E14 5AB
United Kingdom
 ORCID ID |
0000-0002-1351-3732 |
|---|---|
| Phone | +44 (0)7480149536 |
| kim@saniushealth.com |
Study information
| Study design | Multicentre observational pilot/feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Digital sickle cell – evaluating live evidence for vaso-occlusive crisis and end-organ damage intervention & prevention: benefits of implementing a unified digital sickle cell disease data platform, including real-time wearable device data, in disease management, patient experience, and clinical outcomes |
| Study acronym | DiSC-ELEVEN |
| Study objectives | To determine the benefits of incorporating a unified digital data platform, in-depth digital patient profile and wearable device into standard care for sickle cell disease - collating historical patient data, a full genetic background, and live patient data - to real-world patient experiences and clinical outcomes. |
| Ethics approval(s) | Submission pending |
| Health condition(s) or problem(s) studied | Sickle cell disease |
| Intervention | The study will be an observational trial, revolving around the use of a mobile app by participants in order to provide initial consent to participate and share their medical records with the study, key details, and link a wearable smartwatch. The trial of the technology will be ongoing for 12 months, and participants will wear either their own or a study-provided smartwatch during their day-to-day lives, in order to track their vital parameters on a constant and automated basis. These will include metrics such as heart rate and activity levels. The study will also involve the collation of each participant's hospital and medical GP records alongside this live wearables collected data, within the digital platform. The participant will need only provide informed consent for this, and the study team will manage the data requests and integration. The digital data platform will unify information from multiple sources in order to provide a full patient profile that can be accessed by both patients and their clinicians. No further interventions will be involved, patients only required to wear their smartwatch on a daily basis in order for the device to collect key health metrics on an automated basis. The study will be conducted remotely, patients participating in initial pre-study focus groups virtually, over video call, in addition to a post-study focus group at the end of the trial. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mobile app and wearable smartwatch |
| Primary outcome measure | 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 3 months 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of the follow-up period at 13 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2020 |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 5 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Children with sickle cell disease of any phenotype aged 5-15 years of age, with consent from and attendance/guidance by parent or legal guardian 2. Adults with sickle cell disease of any phenotype aged 16 years and over 3. Able and willing to sign written informed consent 4. Interest in participating in the study 5. Known history/diagnosis of sickle cell disease |
| Key exclusion criteria | 1. Incapacity to provide informed written consent 2. Known allergic reaction to any materials in wearable device |
| Date of first enrolment | 01/12/2024 |
| Date of final enrolment | 01/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Central Middlesex Hospital
Acton Lane
London
NW10 7NS
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Sponsor information
Other
Level 39
One Canada Square
Canary Wharf
London
E14 5AB
United Kingdom
| Phone | +44 (0)7784288499 |
|---|---|
| orlando@draperanddash.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, as well as a patient-friendly report of key findings and insights at a de-identified level provided to study participants. |
| IPD sharing plan | The researchers do not plan to share patient-level/raw data, as they anticipate some participants may wish to continue using the digital platform post-trial as part of their disease management. De-identified, cohort-level data will be made available upon request by clinicians, researchers who provide a methodologically sound proposal, or those developing novel therapeutic options who may require the real-world evidence base generated by the study. These proposals should be directed to Dr Kim Summers, kim@saniushealth.com, and will include a data access agreement. Links to the data will be provided upon request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1 | 03/09/2020 | 08/10/2020 | No | No |
Additional files
- ISRCTN16126140_PROTOCOL_V1.3_Sep20.pdf
- Uploaded 08/10/2020
Editorial Notes
09/09/2024: The recruitment start date was changed from 01/09/2024 to 01/12/2024.
11/06/2024: The recruitment start date was changed from 01/06/2024 to 01/09/2024.
30/01/2024: The following changes were made:
1. The study contacts were updated.
2. The recruitment start date was changed from 01/06/2021 to 01/06/2024.
3. The recruitment end date was changed from 01/12/2021 to 01/12/2024.
4. The overall study end date was changed from 22/05/2023 to 01/12/2025.
5. The intention to publish date was changed from 22/05/2023 to 01/12/2026.
26/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/07/2021 to 01/12/2021.
2. The overall trial end date has been changed from 22/05/2022 to 22/05/2023 and the plain English summary updated accordingly.
22/01/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2021 to 01/06/2021.
2. The recruitment end date was changed from 01/02/2021 to 01/07/2021.
04/12/2020: The following changes have been made:
1. The recruitment start date has been changed from 01/12/2020 to 01/01/2021.
2. The recruitment end date has been changed from 15/12/2020 to 01/02/2021.
26/10/2020: The recruitment start date was changed from 01/10/2020 to 01/12/2020.
08/10/2020: Uploaded protocol Version 1.3, September 2020 (not peer reviewed).
09/09/2020: Trial's existence confirmed by Health Research Authority.
