SclerodermaCoDUoNCT05785403
Co-designing Digital Ulcers Opportunities With Patients and Clinicians
An observational study of Scleroderma and Scleroderma Associated Digital Ulcer, run by King's College London.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Scleroderma, Scleroderma Associated Digital Ulcer, Digital Ulcer
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare professionals who see patients with SSc DU Patients diagnosed with SSc DU
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Co-designing Improvements in Care and Self-care Opportunities for Scleroderma Digital Ulcers With Patients and Clinicians
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.
Read more
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
- to explore how patients with SSc DU are currently managed
- to understand how they currently manage their ulcers and their healthcare needs.
- 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..
- Being tested
- No intervention
- Medical subject headings
- Scleroderma, Diffuse, digital ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785403
- Sponsor's protocol ID
- IRAS 320344
- Acronym
- CoDUo
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-designing Improvements in Care and Self-care Opportunities for Scleroderma Digital Ulcers With Patients and Clinicians
- ClinicalTrials.gov ID
- NCT05785403
- Acronym / sponsor ID
- CoDUo / IRAS 320344
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- to explore how patients with SSc DU are currently managed
- to understand how they currently manage their ulcers and their healthcare needs.
- 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..
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals who see patients with SSc DU Patients diagnosed with SSc DU
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Qualitative co-designed self-care interventions and improved DU care services
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma and Scleroderma Associated Digital Ulcer, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative co-designed self-care interventions and improved DU care services (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.