Lupus & antiphospholipid syndrome
Evaluation and randomised controlled trial of home urinalysis testing in patients with SLE at elevated risk for developing lupus nephritis: a study protocol
Study context
- Population
- Patients with SLE at elevated risk of de novo lupus nephritis (LN) or relapseplanned: pilot n=18
- Planned comparison
- Weekly home urine sampling protocol with text-messaging reminder and data capture vs standard care
- Primary endpoint
- Biopsy eligibility: clinical indication for kidney biopsy (urine protein-creatinine ratio≥0.5), whether or not biopsy is performed
Methodological detailssingle-group feasibility pilot, comparative effectiveness trial, economic evaluation, Feasibility pilot, single-group design (n=18), with feasibility assessment and qualitative debriefing interviews with patients to refine the intervention, Second phase: comparative effectiveness trial (n=160), including an economic evaluation of the adapted home urinalysis protocol, Trial to be registered with ClinicalTrials.gov prior to enrolment start
- Single-group feasibility pilot
- Comparative effectiveness trial
- Economic evaluation
- Feasibility pilot, single-group design (n=18), with feasibility assessment and qualitative debriefing interviews with patients to refine the intervention
- Second phase: comparative effectiveness trial (n=160), including an economic evaluation of the adapted home urinalysis protocol
- Trial to be registered with ClinicalTrials.gov prior to enrolment start
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Evaluation and randomised controlled trial of home urinalysis testing in patients with SLE at elevated risk for developing lupus nephritis: a study protocol. Lupus Sci Med. Published 21 November 2024. doi:10.
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