Co-designing Digital Ulcers Opportunities With Patients and Clinicians

NCT05785403 | Unknown

• 1 other identifier: IRAS 320344
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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. 1.to explore how patients with SSc DU are currently managed
2. 2.to understand how they currently manage their ulcers and their healthcare needs.
3. 3.to collaboratively co-design self-care opportunities and improvements in care.

Conditions

Scleroderma; Scleroderma Associated Digital Ulcer; Digital Ulcer

Outcome Measures

Primary Outcomes (1)

• Qualitative co-designed self-care interventions and improved DU care services

  Patients and healthcare professionals will be recruited for consultation observations and interview to find out DU care needs. The qualitative analysis will lead to jointly co-designing self-care interventions and DU care service re-design.

  12 months

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare professionals who see patients with SSc DU Patients diagnosed with SSc DU

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Scleroderma, Diffuse; digital ulcers

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 27, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03