Patient-reported Outcome Measures Collected in DANBIO Via a From Home Web Application Versus a Touchscreen in the Outpatient Clinic Among Patients With Systemic Lupus Erythematosus: A Randomised, Crossover, Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Systemic Lupus Activity Questionnaire global health
研究概览
简要总结
A randomised, within-participants cross-over design trial including 34 patients with systemic lupus erythematosus. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO webapp and thereafter via the outpatient touchscreen or vice versa.
详细描述
The aim of this trial is to evaluate whether electronic reporting of PROMs through the DANBIO web application (webapp) is comparable to the outpatient touchscreen among patients with SLE.
The trial is a randomised, crossover, agreement study where 34 patients with SLE from the Department of Rheumatology at Aalborg University Hospital will be included and randomised in ratio 1:1 to:
- Group 1: PROMs are reported through the DANBIO webapp; thereafter, the touchscreen.
- Group 2: PROMs are reported through the touchscreen; thereafter, the DANBIO webapp.
There will be a wash-out period of 1-2 day between the two registrations to minimise carryover bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed in DANBIO with SLE
- •Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)
排除标准
- •Inability to provide informed consent or to comply with the study protocol
- •Diagnosis of SLE of ≥ 12 months
- •Does not have access to a device that can run the DANBIO webapp
研究组 & 干预措施
Group WT
PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen
干预措施: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order (Device)
Group TW
PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp
干预措施: PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order (Device)
结局指标
主要结局
Change in Systemic Lupus Activity Questionnaire global health
时间窗: Day 1 (first data registration) and day 3 (second data registration)
Evaluates global assessment of lupus activity using an NRS score from 0-10. Higher score Means worse outcome.
次要结局
- Visual Analogue Scale for Pain(Day 1 (first data registration) and day 3 (second data registration))
- Visual Analogue Scale for fatigue(Day 1 (first data registration) and day 3 (second data registration))
- Patient Global Visual Analogue Scale(Day 1 (first data registration) and day 3 (second data registration))
- Patient Acceptable Symptom State (PASS)(Day 1 (first data registration) and day 3 (second data registration))
- Anchoring question(Day 1 (first data registration) and day 3 (second data registration))
- SLAQ flare score(Day 1 (first data registration) and day 3 (second data registration))
- SLAQ symptom score(Day 1 (first data registration) and day 3 (second data registration))
- SLAQ total score(Day 1 (first data registration) and day 3 (second data registration))
- Change in Health Assessment Questionnaire (HAQ)(Day 1 (first data registration) and day 3 (second data registration))
研究者
Salome Kristensen
Chief physician, PhD, Principal Investigator
Aalborg University Hospital