An observational study in Scleroderma, Scleroderma Associated Digital Ulcer and Digital Ulcer, sponsored by King's College London. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by King's College London · Observational
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
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..
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's planned enrollment of 25 is below the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthcare professionals who see patients with SSc DU Patients diagnosed with SSc DU
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
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.
Time frame: 12 months
No study locations are listed for this record.
Start is estimated for Jun 2023; primary completion for Dec 2023, 6 months later.
Of 32 observational studies under Scleroderma, Diffuse, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 44. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.