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Sickle Cell DiseaseNCT06293222

Patient and Public Involvement and Engagement in Research With Children and Young People With Sickle Cell Disorder and Their Families

An observational study of Sickle Cell Disease, run by King's College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Sickle Cell Disease
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
21 Aug 2023to 30 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: * Group A: Members of a patient advocacy organisation (Sickle Cell Society n=5) * Group B: i) Children and young people (10-18 years) with sickle cell disorder (n=15) ii) their siblings (10-18 years, n=10) iii) their parents (n=15) * Group C: Researchers working with children with life-limiting or life changing conditions

Who may be able to join

  • Group A: Members of a patient advocacy organisation (Sickle Cell Society n=5)
  • Group B:
  • Children and young people (10-18 years) with sickle cell disorder (n=15) ii) their siblings (10-18 years, n=10) iii) their parents (n=15)
  • Group C: Researchers working with children with life-limiting or life changing conditions

Who cannot join

  • Group A: Members of patient advocacy organisations other than the Sickle Cell Society
  • Group B:
  • Children and young people younger than ten years or older than 18 years and those without sickle cell disorder (n=15) ii) siblings younger than ten years or older than 18 years and without a brother or sister with sickle cell disorder iii) parents of children with conditions other than sickle cell disorder
  • Group C: Researchers who do not have experience working with children with life-limiting or life changing conditions

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • King's College London

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: Patient and Public Involvement and Engagement in Research on Life-limiting Conditions With Children and Young People With Sickle Cell Disorder and Their Families

Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families.

Methods: Workshops with a) members of a patient advocacy organisation (Sickle Cell Society n=5) b): i) Children and young people (10-18 years) with sickle cell disorder (n=15) and ii) their siblings (10-18 years, n=10) and iii) their parents (n=15), c) Researchers form the Cicely Saunders Institute Outputs: Resources that enable children and young people with sickle cell disorder and their families to engage in research

Read the detailed description

Aim:

To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families.

Objectives:

  1. Partner and collaborate with the Sickle Cell Society to continue to build on the work of the Cicely Saunders Institute to support a thriving Patient and Public Involvement and Engagement community that includes children and young people and their families
  2. Listen, hear, and understand what is important for children and young people with sickle cell disorder and provide them with the knowledge and skills to collaborate with researchers at the Cicely Saunders Institute during the design and implementation, analysis, and publication of research
  3. Equip staff within the Cicely Saunders Institute with the knowledge, understanding and awareness of the role children and young people with sickle cell disorder and their families can play in patient-involved research to ensure pathways for prioritizing and disseminating patient led research are realised
  4. Use data from objectives 1-3 to co-produce resources that may be used with a broader population of children and young people with serious and life-limiting conditions and their families to enable them to become equal partners in research
  5. Use learning from the proposed project with the Sickle Cell Society as an exemplar partnership, to inform future Patient and Public Involvement and Engagement with children and young people with other serious and life-limiting conditions including cancer and neuro-disabilities as the investigators expand the research remit at the Cicely Saunders Institute.

Background:

Public involvement must be diverse and inclusive to enable research that has the potential to reach those that stand to benefit from it the most, and thus to address issues of health equity and accessibility. Yet, long-standing evidence has shown that those most likely to be involved in research come from a narrow section of the population, from older age groups, white ethnic and higher socio-economic backgrounds. It is widely recognised that many groups are underserved and underrepresented in research.

Underserved groups include children, young people and adults from different minority ethnic groups, socio-economically disadvantaged groups, migrants, asylum seekers, people with mental health conditions and multiple health conditions. Children and young people, as a group have few opportunities for research involvement. There is also limited evidence on optimal models for partnerships in research.

Changing the balance of power and promoting wider participation, empowerment, diversity, and equality, are seen as neglected aspects of involvement that, if given due attention, can offer a way to move beyond involvement at the lowest levels of consultation to partnering and collaborating with a wider diversity of people and communities.

Methods:

Design: A sequential design involving three work packages

  • WP1 will address Objectives 1 and 2: Apr-June 2023

The investigators will hold separate child and adult online/face to face scoping workshops (n=3) with:

Group B(i) children and young people with sickle cell disorder (n=15) and B(ii) their siblings (n=10) and B(iii) their parents (n=15) recruited via charity partners to:

(i) Explain what research is, how it is conducted, relevant policies and the mission statement of the Cicely Saunders Institute (ii) Review structures and processes for equitable and inclusive Patient and Public Involvement and Engagement for children and young people with sickle cell disorder and their families (iii) Identify relevant and appropriate training/education/skills needed to enable children and young people with sickle cell disorder and their families to engage in research.

The child and young people's workshop will be facilitated by an artist to assist with activities to engage participants. These workshops will be evaluated by those involved using surveys which will be administered at the end of the workshops.

  • WP2 will address objective 3: Jul-Aug 2023 The investigators will hold online/face to face workshops (n=2) with researchers from the Cicely Saunders Institute (n=10) and members of Group B (n=10-15) to enable them to work together to identify resources needed for meaningful Patient and Public Involvement and Engagement with children and young people with sickle cell disorder and their families to take forward into WP3. These workshops will also be evaluated by those involved using surveys which will be administered at the end of the workshops.
  • WP3 will address objectives 4 and 5: Sept-Dec 2023 Through a combination of online/face to face working groups (n=2), the investigators will work with children and young people with sickle cell disorder and their families (n=10-15 at each workshop) as well as researchers from the Cicely Saunders Institute (n=5) to co-produce resources that enable them to engage meaningfully in research incorporating the skills and knowledge identified in WP1. One of these workshops will be facilitated by an artist to help children develop their ideas into future resources for meaningful Patient and Public Involvement and Engagement. This will facilitate their involvement in future funding applications that are driven by them.

The investigators will have a final celebratory event with Group A: Sickle Cell Society and Groups B(i) children and young people with sickle cell disorder (n=15), Bii) their siblings (n=10) and Biii) their parents (n=15) to showcase achievements and plan next steps. The celebratory event will include an evaluation of the whole project.

Outputs:

WP1: (i) Partnership with a charity organisation, the Sickle Cell Society (ii) guidance on reaching minority ethnic groups and publicizing research opportunities; (iii) training skills analysis to enable children and young people with sickle cell disorder and their families to engage in research in a meaningful way.

WP2: Identification of resources needed to facilitate meaningful involvement of children and young people with sickle cell disorder and their families to engage in research WP3: (i) Resources that enable children and young people with sickle cell disorder and their families to engage in research (ii) a future strategy for meaningful Public Involvement and Engagement with children and young people with sickle cell disorder and their families (iii) an exemplar to inform future Patient and Public Involvement and Engagement with children and young people with other serious and life-limiting conditions including cancer and neuro-disabilities as the investigators expand the research remit.

Medical subject headings
Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06293222
Study groupRoleWhat they receive
Participants with personal experience of sickle cell disorder.Participants with personal experience of sickle cell disorder (parents, affected children or siblings).
ResearchersResearchers working with children with life limiting or life changing conditions
Members of a patient advocacy organisationMembers of a patient advocacy organisation (Sickle Cell Society)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Workshops with participants to develop resources that enable children and young people with sickle cell disorder and their families to engage in research

    Resources that enable children and young people with sickle cell disorder and their families to engage in research

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start21 Aug 2023
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06293222
Sponsor's protocol ID
SCD Support
Status last verified
Mar 2024
First submitted
27 Feb 2024
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data from the study are likely to be made available on request from the CI. Data may not be publicly available due to ethical constraints.

Publications

  • Chudleigh J, Follett A, Mcfarlane-Griffith E, Abuo D, Josh, Imani, Holder P. Exploring How Children and Young People With Sickle Cell Disease and Their Families Want to be Involved in Research: A Qualitative Study. Health Expect. 2025 Apr;28(2):e70242. doi: 10.1111/hex.70242.

    PubMed 40152512

Questions about this trial

What is this clinical trial studying?

An observational study of Sickle Cell Disease, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Workshops with participants to develop resources that enable children and young people with sickle cell disorder and their families to engage in research (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06293222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

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