Co-design and feasibility testing of a tailored self-management intervention for adults living with sickle cell disease

Background Sickle Cell Disease (SCD) is an inherited blood disorder associated with multisystem complications, acute and persistent pain and fatigue.

SCD-related pain results in biopsychosocial impacts including reduced physical and emotional wellbeing and HRQoL, and increased healthcare utilisation. Most of the 15,000 people with SCD (PwSCD) in England are from African or Caribbean backgrounds. Negative and racist attitudes towards PwSCD have been reported to impact healthcare experiences.

Health inequalities have the greatest impact on minoritised groups and racially minoritised groups are currently underrepresented in research. PwSCD must self-manage their condition much of the time.

However, there is a lack of evidence identifying the self-management skills that are most effective and utilised most, and the support that would be valued, by PwSCD.

Clinicians lack training to support self-management for PwSCD and PwSCD lack of access to a tailored self-management intervention. This project will co-design a self-management intervention with PwSCD and Health Care Professionals (HCPs).

Aim: To co-design a tailored self-management intervention for adults with SCD and conduct a single-arm feasibility study. Objectives.

To: Use Experience-Based Co-Design (EBCD) methodology to identify priorities for a tailored self-management intervention for adults with SCD, using the experiences of PwSCD and HCPs and existing self-management evidence.

Use EBCD to co-design and produce the intervention, which will include resources (e.g.narratives from PwSCD describing their effective self-management approaches) and a training package for HCPs. Produce a preliminary Theory of Change. Train HCPs to deliver the intervention, according to key fidelity markers.

Conduct a single-arm feasibility study. Methods: Three work packages (WP) will be delivered in 48 months using mixed methods (MM).

Intervention development will be informed by a systematic review (in progress), behaviour change methods, the construct of self-efficacy, and social cognitive theory. WP1 will focus on gathering experiences of PwSCD and HCPs to inform priorities for the intervention.

A composite film, edited following thematic analysis of narrative interviews with PwSCD, will be an output.(Month:5-13) WP2 will focus on intervention co-design (resources and HCP training package). A Preliminary theory of change will be developed.

A MM evaluation of experiences of ECBD will be completed.(Month:14-25) WP3 HCPs will be trained to deliver the intervention.

A single-arm feasibility study (target n=40) will be conducted at two sites to assess: Recruitment Retention Ability to collect outcome measures Acceptability Fidelity Patient reported outcome/ process measures (pain intensity and interference, QoL, emotional and social impact of pain, self-efficacy) to identify a primary outcome measure and enable sample size calculation for a future RCT.

Data will be collected at baseline, on completion of the intervention and at three-month follow-up.

The study protocol and findings will be published.(Month:24-46) Impact This project will widen access to self-management support contextualised to the needs and experiences of PwSCD, addressing a currently unmet need.

The intervention will enable PwSCD to learn from others who have found effective ways to self-manage aspects of their condition. HCPs will be upskilled through intervention training.

Dissemination Three peer reviewed publications Two conference posters Plain English summaries/newsletters/infographics EBCD celebration event Webinar sharing feasibility findings