Co-designing Digital Ulcers Opportunities With Patients and Clinicians

NCT ID: NCT05785403

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-06-30

Brief Summary

Scleroderma (SSc) 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 SSc (PwSSc), as they approximately affect more than half of these patients. Care received by PwSSc DU is varied. Patients with three or more ulcers are considered to have severe disease therefore these patients usually receive expensive treatments and referred to specialist SSc clinics, while those with less ulcers may not receive the same treatments, and only see their general practitioner or local rheumatologist or left to their own means. Resulting in patients developing their own DU managing practices which may be good and some not.

Currently, no research has fully identified the needs of PwSSc DU and self-care interventions to support them are lacking. The extent to which DU support needs are met by non-specialist health professionals is unknown. There is lack of literature in co-designing interventions with patients in SSc DU. Developing interventions and pathways for managing DU with patients and healthcare professionals (HCP) will enhance DU care and lessen the burden for the affected patients, a qualitative study is required.

Aim The aim of this research is to co-design self-care opportunities and develop improvements in DU care.

Objectives

1. to explore how patients with SSc DU are currently managed

2. to understand how they currently manage their ulcers and their healthcare needs.

3. to collaboratively co-design self-care opportunities and improvements in care.

Study Methods Experience-based co-design (EBCD) qualitative methodology will be used to conduct the study. 10 HCP and 12-15 PwSSc DU will be invited to participate in consultation observations. Followed by individuals interviews for the HCP and PwSSc DU care and perceptions on unmet needs. The results will inform collaborative co-designing and development of interventions with patients and HCP. The same participants will also be invited to participate in three workshops involving designing, discussion, refinement and finalisation of the interventions. The interventions developed will be ready to be tested or being evaluated once they have been put in place..

Conditions

Scleroderma; Scleroderma Associated Digital Ulcer; Digital Ulcer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthcare Professionals who see People with SSc DU
• Patients ≥18 years old
• Patients fulfilling the 2013 American College of Rheumatology -European Alliance of Associations for Rheumatology classification criteria for SSc
• Patients with a history of previous DU or current DU regardless the number of ulcers
• Participants able to provide informed written consent

Exclusion Criteria

• Healthcare professionals who see patients with rheumatological conditions but not SSc
• Patients aged below ≤18 years old
• Patients with DU, however without diagnosis of SSc
• Patients diagnosis of SSc who have never had DU
• Participants who do not speak English, hence cannot provide informed consent, or participant in interviews

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRAS 320344

Identifier Type: -

Identifier Source: org_study_id