Co-designing DU opportunities

  • Research type

    Research Study

  • Full title

    Co-designing improvements in care and self-care opportunities for scleroderma digital ulcers with patients and clinicians

  • IRAS ID

    320344

  • Contact name

    Jackie Sturt

  • Contact email

    jackie.sturt@kcl.ac.uk

  • Sponsor organisation

    Kings College London

  • Clinicaltrials.gov Identifier

    NCT05785403

  • Clinicaltrials.gov Identifier

    ClinicalTrials.gov Identifier, NCT05785403

  • Duration of Study in the UK

    1 years, 0 months, 30 days

  • Research summary

    Research Summary:

    Scleroderma is a rare crippling chronic disease associated with damage of the blood vessels and hardening of connective tissue. It has quite a number of complications including ulcers to the fingers and toes (digital ulcers). Digital ulcers (DU) are a frequent challenge in patients with scleroderma, as they approximately affect more than half of these patients. These ulcers are very painful, take a long time to heal, and are disabling. In most severe form, they lead to complications such as infection and amputations. These complications may result in hospital admissions, loss of work, ill-health, and reduced quality of life. Care received by patients with DU is varied. Those with three or more ulcers are considered to have severe disease therefore they usually receive expensive treatments and referred to specialist scleroderma clinics, while those with fewer ulcers may not receive the same treatments, and only see their general practitioner or local rheumatologist or are left to their own means. These patients develop their own DU managing practices which may be good and some not.

    Currently, no research has fully identified the needs of patients with DU and opportunities to improve the ulcer care are lacking. We do not know the extent to which DU support needs are met by non-specialist healthcare professionals. Developing self-care opportunities and pathways for managing DU with patients and healthcare professionals will enhance DU care.

    The aim of this research is to co-design self-care opportunities and improvements in care with patients suffering from DU and healthcare professionals. The objectives include; examining how patients are currently managed, identifying how patients currently manage their DU, what their unmet needs are and to co-design self-care opportunities and ways to improve DU care with patients and healthcare professionals.

    Summary of Results:

    Background For up to 70% people diagnosed with scleroderma (SSc), digital ulcers (DU) remain a huge burden. These ulcers are a burden to the overall wellbeing of the affected people limiting hand functionality and activities of daily living. Literature shows considerable variability in care received according to access to specialist services. Evidence for the treatment and self-care needs of DU patients is lacking.

    Aim
    The aim of the study is to co-design self-care opportunities and improvements in DU care.

    Methods
    Experience Based Co-design (EBCD) methodology will be used to conduct this project. This method seeks to include both patients and healthcare professionals to develop best ways of delivering a service or intervention. EBCD enables excellent experience for patients and allows their voices to be heard so that their experiences can be understood and know what needs to be improved to change their experiences for the better.

    Summary Results
    The six stages of EBCD were held including setting up the study, consultation observations and clinician interviews, filmed interviews, feedback events, co-designing workshops and the celebratory event. Collaboration discussions following clinicians and patients watching the produced patient film, identified key priorities to be co-designed to meet patients’ unmet needs. We took the key priorities and have co-designed interventions that will impact patients with digital ulcers at large.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    23/NW/0206

  • Date of REC Opinion

    18 Aug 2023

  • REC opinion

    Further Information Favourable Opinion