PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE
2021年3月30日 更新者：Salome Kristensen
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
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
34
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Aalborg、丹麦、9000
- Department of Rheumatology
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 110年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosed in DANBIO with SLE
- Experience with the PROM questionnaires in DANBIO (≥ 1 previous assessments)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Group WT
PROM registration via the DANBIO WebApp and thereafter the outpatient touchscreen
|
PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
|
|
其他：Group TW
PROM registration via the outpatient touchscreen and thereafter the DANBIO WebApp
|
PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Systemic Lupus Activity Questionnaire global health
大体时间：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.
|
Day 1 (first data registration) and day 3 (second data registration)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Health Assessment Questionnaire (HAQ)
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
Assess the patient's physical function from 0-3.
Higher score Means worse outcome.
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
Visual Analogue Scale for Pain
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
The patient's assessment of pain on a scale from 0-100 within the last week.The left of the scale (0) signifies the absence of pain and the right end (100) maximum pain.
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
Visual Analogue Scale for fatigue
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
The patient's assessment of fatigue on a scale from 0-100 within the last week.
The left of the scale (0) signifies the absence of fatigue and the right end (100) maximum fatigue.
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
Patient Global Visual Analogue Scale
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
The patient's global assessment of disease activity (arthritis severity) on a scale from 0-100 within the last week.
The left of the scale (0) signifies the absence of arthritis activity and the right end (100) maximum arthritis activity.
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
Patient Acceptable Symptom State (PASS)
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
The patient's assessment of acceptable symptom state.
Consist of one question answered with "yes" or "no".
The question is: ''Take into account all the ways in which your arthritis has affected you in the past 48 hours.
If you were to remain for the next few months as you are today, would it be acceptable to you?"
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
Anchoring question
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
The patient's assessment of change in arthritis activity since last visit from much worse to much better.
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
SLAQ flare score
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
Evaluates presence or severity of lupus flare on a transitional scale e.g.
0 (no worsening), 1 (mild worsening), 2 (moderate worsening) or 3 (severe worsening).
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
SLAQ symptom score
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
Evaluates the number of lupus specific symptoms present from 0-24.
Higher score means worse outcome.
|
Day 1 (first data registration) and day 3 (second data registration)
|
|
SLAQ total score
大体时间：Day 1 (first data registration) and day 3 (second data registration)
|
Evaluates severity of lupus disease activity by a weighted score of the 24 lupus specific symptoms, range 0-44.
Higher score means worse outcome.
|
Day 1 (first data registration) and day 3 (second data registration)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Salome Kristensen, MD, PhD、Department of Rheumatology, Aalborg University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年7月15日
初级完成 (实际的)
2020年11月25日
研究完成 (实际的)
2020年11月25日
研究注册日期
首次提交
2020年5月28日
首先提交符合 QC 标准的
2020年5月28日
首次发布 (实际的)
2020年6月2日
研究记录更新
最后更新发布 (实际的)
2021年4月1日
上次提交的符合 QC 标准的更新
2021年3月30日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Study protocol and the SAP will be published as supplementary information to the article.
IPD from this trial that underlie results in a publication will be made available in clinicaltrials.gov
after publication of the article.
IPD 共享时间框架
Will be made available when the article is published
IPD 共享访问标准
Study protocol and the SAP will be published as supplementary information to the article.
IPD from this trial that underlie results in a publication will be made available in clinicaltrials.gov
after publication of the article.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.