Lupus SLE
Conditions
Interventions
Patients will be grouped per treatment centre (cluster), where two out of the
four study centres will treat patients according to T2T, for which a target
will be defined by integrating all important
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age 18 years or older - Diagnosed with SLE according to the American College of Rheumatology (ACR) revised criteria for the classification of SLE. - Signed informed consent form
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Life-threatening SLE manifestations that require intensive care treatment - Pregnancy or breastfeeding during the time period of the pilot study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A mixed methods approach will be adopted to establish usability, feasibility and acceptability. Data will be collected to assess the following primary endpoints: • Usability: Adherence rates and System usability scale (SUS) • Feasibility: Recruitment and retention rates, time required to recruit to target sample, number of eligible participants required to recruit required sample size, rate of completion of the intervention (i.e. number of participants who complete all aspects of the intervention) • Acceptability: assess through qualitative and quantitative questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Although the pilot study is not powered to detect clinically significant changes in clinical outcome measures, we will collect these as secondary data in order to generate interval estimates of the change and to also determine whether the testing components that would be used in a larger evaluation are feasible. - Changes in disease activity (reported by cSLEDAI-2k and PGA) - Damage accrual at week 24 (SDI), - HRQoL (SF-36) - Proportion of disease flares apparition (SLEDAI-2K flare index) These data could enable the statistical power calculations for a subsequent larger scale evaluation to assess the effectiveness of the T2T intervention as part of routine outpatient care. | — |
Countries
Netherlands
Outcome results
None listed