SCORE - Sickle cell outreach, resources & engagement
| ISRCTN | ISRCTN17711930 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17711930 |
| Secondary identifying numbers | NIHR 207898 |
- Submission date
- 05/08/2025
- Registration date
- 12/08/2025
- Last edited
- 12/08/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
Sickle cell disease (SCD) primarily affects ethnic minorities, so in addition to having a chronic health condition requiring lifelong medical care and frequent hospitalisations, patients experience stigma and poverty, with consequent marginalisation and disparities in healthcare.
The study research questions focus on exploring the functions, operation and locations of community SCD health and wellbeing hubs that bridge the community-health service interface. The questions have been articulated by our Liverpool sickle cell patients and their carers to reflect their need for more holistic, patient-centred care in their communities. These hubs could provide holistic and culturally appropriate support, thereby improving SCD patients’ wellbeing and resilience. This would also benefit health services by reducing workload and helping patients navigate NHS access pathways more effectively.
This research responds to a highly critical UK government report highlighting the neglect of SCD and recommending improvements in community provision. In the UK, funding for SCD is disproportionately low compared to other chronic diseases and resources are concentrated in high-prevalence areas. There is very little evidence to guide the design and function of community SCD hubs that is transferable to the Liverpool area, where prevalence is low. Evidence from the USA, from non-SCD chronic conditions and from studies of social determinants of health indicates that community hubs can reduce hospital visits and improve quality of life, resilience and patient outcomes. Examples of potential SCD hubs’ functions include health education, counselling and advice on screening and ‘buddies’ for hospital appointments.
Who can participate?
Adolescents aged 15+ living with SCD (with parental consent and their consent), adult carers of people with SCD, SCD healthcare providers, relevant stakeholders (e.g. from social services, Citizens Advice, councils, and academia), and individuals working with community or non-governmental organisations supporting those affected by SCD.
What does the study involve?
This 15-month project will collate and use evidence to co-design (with patients/carers) community SCD hubs for Liverpool (i.e. an intervention) for trialling in a subsequent study, focusing on adult healthcare and the paediatric adult transition. The methodological framework is the Delphi process with three rounds of engagement with 8-10 diverse, representative participants to achieve a consensus recommendation about the intervention. Additional information from a scoping literature review, survey, focus group discussions and interviews will feed into the Delphi discussions. At the centre of all our activities are community research champions who will be trained and supported, drawing on the Research Delivery Networks (RDNs) successful model for engaging marginalised communities in research.
Our primary output is a ‘test-ready’ intervention to trial 4-5 SCD community hubs and to assess feasibility, acceptability and potential evaluation metrics. Secondary outputs include a literature review (month 5), a cohort of trained community research champions (start month 3), community engagement in research, a co-refined Theory of Change to underpin future testing of the intervention, and workshops (months 3,14) to gain multiple perspectives and share our findings with relevant local organisations.
Building on applicants’ and collaborators’ networks, the list of target organisations for knowledge sharing will be extended, and the timing and best modes (e.g. social media, face-to-face, publications) for reaching them will be determined. Ultimately, the impact will be to contribute to reducing health disparities for SCD patients in Liverpool and to relieving pressure on the NHS, simultaneously strengthening patients’ research engagement and trust in health services to reduce their marginalisation.
What are the possible benefits and risks of participating?
There will be no direct benefits to study participants, but this study will help us to understand the key factors to improve the wellbeing and resilience of people living with sickle cell disease and how resource centres can help to realise this.
This is a very low-risk study, as it only asks participants to reflect on their experiences and how they feel community resource centres or hubs for sickle cell disease patients will be helpful. However, if participants have had some unpleasant experiences, this might be difficult for them to talk about. These experiences are not being asked about directly, but if at any point the questions are upsetting to participants, they can pause the survey or stop it altogether. Participants can decline to answer any questions they are not comfortable answering.
Where is the study run from?
Liverpool School of Tropical Medicine (LSTM), UK
When is the study starting and how long is it expected to run for?
May 2025 to August 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR), UK
Who is the main contact?
Ms Susie Crossman, susie.crossman@lstmed.ac.uk
Contact information
Public, Scientific, Principal Investigator
LSTM Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)1517052564 |
|---|---|
| susie.crossman@lstmed.ac.uk |
Study information
| Study design | Observational - Delphi reflection cycles |
|---|---|
| Primary study design | Observational |
| Secondary study design | Delphi reflection cycles |
| Study setting(s) | Community |
| Study type | Quality of life, Treatment |
| Participant information sheet | 47780_PIS_v1_01April2025.pdf |
| Scientific title | Exploring the design and operation of community health and wellbeing sickle cell hubs (‘sickle hubs’) to relieve pressure on GPs and hospital services |
| Study acronym | SCORE |
| Study objectives | Improve patients’ and families’ wellbeing and resilience, reduce NHS workload and help patients access NHS pathways more effectively. |
| Ethics approval(s) |
Submitted 05/08/2025, Liverpool School of Tropical Medicine (LSTM) Research Ethics Committee (REC) (Pembroke Place, Liverpool, L3 5QA, United Kingdom; +44 (0)151 705 3100; lstmrec@lstmed.ac.uk), ref: 25-037 |
| Health condition(s) or problem(s) studied | Sickle cell disease |
| Intervention | Delphi reflection cycles on the feasibility of sickle cell community treatment hubs. This is an exploratory study to explore potential functions, operation, feasibility, acceptability and potential measures of success of community resource centres or hubs for people living with sickle cell disease. The study will use the Delphi framework and will recruit participants for Delphi reflection rounds, surveys, focus group discussions and key informant interviews. There will also be community research champions who will co-facilitate the Delphi rounds, focus group discussions and key informant interviews. The survey will be anonymous, conducted online, and participants are expected to spend no more than 30 minutes responding to survey questions. Participants for the Delphi rounds will be engaged 3-4 times throughout the study for 2 hours per round (total 6-8 hours). Participants for focus group discussions will take part in two roundtable discussions lasting 90 minutes each (total 3 hours), while participants for key informant interviews will be interviewed 2-3 times during the study, lasting 1 hour each (total 2-3 hours). Community research champions will undergo 4-5 training sessions totalling 24 hours, and will co-facilitate Delphi rounds totalling 6-8 hours, focus group discussions totalling 3 hours and key-informant interviews totalling 2-3 hours. Community research champions will be engaged for a total of approximately 35-38 hours. |
| Intervention type | Mixed |
| Primary outcome measure | A 'test-ready' scalable intervention, in the form of community sickle cell disease hubs, with recommendations for potential locations and evaluation metrics ready to be trialled in a subsequent study. This will be developed from research outputs, including a scoping review [at month 5]; a cohort of trained and experienced community research champions with shareable training resources relevant for sickle cell disease [at month 6]; and a collaboratively refined theory of change [at month 14], to underpin future testing of the hubs developed from the Delphi framework. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 12/05/2025 |
| Completion date | 31/08/2026 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. All participants must willfully consent to participate. 2. Adolescents living with SCD 2.1. Aged 15 and older 2.2. Parent/caregiver has provided informed consent 2.3. Adolescent has given assent to participate 3. Carers of people living with SCD 3.1. Aged 18 and older 3.2. Caring for at least one person with SCD 4. SCD healthcare providers 4.1. Aged 18 and older 4.2. Playing a role in supporting clinical management of patients with SCD, including in hospital and GP practices 5. Stakeholders with potential to input to the functioning of hubs 5.1. Aged 18 and older 5.2. Representatives from social services, Citizens Advice and councils 5.3. Academics (including clinical educators) 6. Working with community-based or non-governmental organisations that support people living with SCD and their families |
| Key exclusion criteria | Not meeting the key inclusion criteria. |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 31/08/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool
L3 5QA
United Kingdom
Sponsor information
Research organisation
LSTM Pembroke Place
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 (0)1517052564 |
|---|---|
| susie.crossman@lstmed.ac.uk | |
| Website | https://www.lstmed.ac.uk/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Knowledge sharing workshops |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 01/04/2025 | 11/08/2025 | No | Yes |
| Protocol file | version 1 | 01/04/2025 | 11/08/2025 | No | No |
Additional files
Editorial Notes
05/08/2025: Study's existence confirmed by the Liverpool School of Tropical Medicine (LSTM) Research Ethics Committee (REC).
