Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05785403
Other study ID # IRAS 320344
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date June 2024

Study information

Verified date March 2023
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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..


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
King's College London Royal Free Hospital NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02798055 - Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Completed NCT03274076 - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) Phase 1/Phase 2
Completed NCT02915835 - Riociguat in Scleroderma Associated Digital Ulcers Phase 2
Active, not recruiting NCT01895244 - Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis Phase 2
Completed NCT00883129 - Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II) Phase 2
Completed NCT00930683 - A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma Phase 1
Completed NCT00074568 - Scleroderma Registry
Recruiting NCT04797286 - Sildenafil for Early Pulmonary Vascular Disease in Scleroderma Phase 2
Completed NCT03222492 - Brentuximab Vedotin for Systemic Sclerosis Phase 1/Phase 2
Completed NCT03207997 - MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients N/A
Recruiting NCT04464434 - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis Phase 4
Recruiting NCT04246528 - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF) N/A
Completed NCT05080738 - Upper Extremity Home Exercises in Patients With Scleroderma N/A
Recruiting NCT03726398 - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH Phase 2/Phase 3
Recruiting NCT05085444 - A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma Early Phase 1
Completed NCT02062125 - Calcinosis in a Single-Center Scleroderma Population
Completed NCT04588714 - Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention N/A
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed NCT02835196 - Optical Elastography of Systemic Sclerosis Skin