Living with Lupus
Research type
Research Study
Full title
‘Living with Lupus’ - developing treatment targets and outcome measures with children and young people to TARGET LUPUS
IRAS ID
255508
Contact name
E Smith
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
JXR13121, Grant account code
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Research Summary
This qualitative study is part of a larger programme of work which is in the early stages of development, entitled TARGET LUPUS. The aim of the TARGET LUPUS study is to develop a clinical trial comparing two different approaches to the treatment of new paediatric Lupus patients. We know that different doctors have their favourite ways to manage Lupus. In this trial, patients would either be ‘treated-to-target’ by following a set structured plan, or treated in the standard way that their doctor usually treats Lupus. Treat-to-target strategies are already used when treating other types of rheumatic disease (e.g. Rheumatoid Arthritis). The current study ‘Living with Lupus’ - developing treatment targets and outcome measures with children and young people to TARGET LUPUS (short title – ‘Living with Lupus’), will allow us to involve children/parents in the early development of the TARGET LUPUS study.‘Living with Lupus’ is funded by the Wellcome Trust. It will involve 24-semi-structured interviews with patients/parents, to help inform the selection of treatment targets and outcome measures for the future TARGET LUPUS study. Lupus patients, aged <18 years, treated in Birmingham, Leeds, London, Leicester and Liverpool will be eligible. Patients will be contacted by their doctor/hospital research nurse and provided with an age appropriate participant information sheet, consent form and an expression of interest form, to allow their contact details to be shared with the study team. On receipt of an expression of interest form, the studies qualitative researcher will contact the families by telephone/email to answer any questions, provide further information and arrange a time, date, location for the interview (45-60 minutes per participant). Following the interview, interviewees will be invited to participate in two stakeholder meetings (two-hours each, over the subsequent 12-months) with other patients/families, to discuss the pre-final treatment targets, tools, protocols and treat-to-target study designs.
Summary of Results
This qualitative study is part of a larger programme of work entitled TARGET LUPUS. The aim of the TARGET LUPUS study is to develop a clinical trial comparing two different approaches to the treatment of new paediatric Lupus patients. We know that different doctors have their favourite ways to manage Lupus. In this trial, patients would either be ‘treated-to-target’ by following a set structured plan, or treated in the standard way that their doctor usually treats Lupus. Treat-to-target strategies are already used when treating other types of rheumatic disease (e.g. Rheumatoid Arthritis).The current study ‘Living with Lupus’ - developing treatment targets and outcome measures with children and young people to TARGET LUPUS (short title – ‘Living with Lupus’), involved semi-structured interviews with 25 patients/parents. Lupus patients were aged <18 years, and treated in Birmingham, Leeds, London, Leicester, Sheffield, Bristol, Nottingham and Liverpool. During the interviews, patients were asked about their views on treatment targets, outcome measures and study designs being considered for a future JSLE treat-to-target (T2T) study.
The interviews showed that patients and parents differed regarding symptoms they felt would be tolerable, representing ‘low disease activity’. Patients often classed symptoms that they had previously experienced, were ‘invisible’ or had minimal disruption on their life as signs of low disease activity. Parents were more accepting of visible signs but were concerned about potential organ involvement and symptom severity. Overall, patients and parents preferred that children were entirely asymptomatic, with no ongoing treatment side effects. They regarded fatigue as particularly challenging, requiring proper monitoring using a fatigue patient-reported outcome measure. Most families felt that reducing corticosteroids would also be a good treatment target. Overall, families liked the concept of T2T, commenting that it could help to improve disease control, help structure treatment and improve communication with clinicians and treatment compliance. They were concerned that T2T might increase the frequency of hospital visits, impacting upon schooling, parental employment and finances. Families made suggestions on how to modify the future trial design to mitigate such effects.
This study provides guidance from patients and parents on T2T targets and study designs. Complementary quantitative studies assessing the achievability and impact of different targets (e.g. lupus low disease activity state or remission) are now warranted to inform an international consensus process to develop treatment targets.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/2103
Date of REC Opinion
7 Feb 2019
REC opinion
Further Information Favourable Opinion