Patient-reported Outcome Measures Collected in DANBIO Reported Via a Smartphone App Versus a Touch Screen Solution in an Outpatient Clinic Among Patients With Inflammatory Arthritis: A Randomised Cross-over Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Health Assessment Questionnaire (HAQ)
研究概览
简要总结
A randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO app on a smartphone first and thereafter via the touch screen solution at the rheumatology outpatient clinic or vice versa. Outcomes are the following PROM: HAQ, VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS.
详细描述
The study is a randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis (RA) (20), psoriatic arthritis (PsA) (20) and axial spondyloarthritis (SpA) (20) from the Rheumatology outpatient clinic at Aalborg University Hospital. The participants will be randomised in ratio 1:1 to:
- Group AT (App → Touch) (30 participants) the participant reports data through the DANBIO app on a smartphone first and after a "washout period" of one day via the touch screen solution at the rheumatology outpatient clinic.
- Group TA (Touch → App) (30 participants): the participant reports data through the touch screen solution at the rheumatology outpatient clinic and after a "washout period" of one day via the DANBIO app on a smartphone.
The primary objective is to evaluate whether electronic reporting of PROM through the DANBIO smartphone app is comparable to the traditional touch screen solution in the rheumatology outpatient clinic among patients with inflammatory arthritis in standard clinical care. The primary outcome is HAQ. Secondary outcomes are: VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS. DAS28crp are estimated using a fixed level for C-reactive protein (CRP) level of 6, swollen joint count of 0.5 and tender joint count of 1. ASDAS are estimated using a fixed level for CRP of 6. These data are based on DANBIO registrations of patients with RA, PsA or SpA from the rheumatology outpatient clinic at Aalborg University Hospital. DAS28crp and ASDAS are estimated from the PROM data to give the clinician an overview of PROM correlating to e.g. remission or high disease activity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A participant will be eligible for study participation if he/she meets the following criteria:
- •Diagnosed in DANBIO with RA, PsA or SpA
- •Is currently treated and monitored at the rheumatology outpatient clinic at Aalborg University Hospital
- •Have previously reported PROM in DANBIO through the touch screen solution at the rheumatology outpatient clinic ≥ 3 times
排除标准
- •A participant cannot be included in the study if he/she meets any of the following criteria:
- •Inability to provide informed consent or unwilling to comply with the study protocol
- •Diagnosis of RA, PsA or SpA ≤ 12 months
- •Does not have access to a smartphone that can download and run the DANBIO app
- •Not able to understand written Danish i.e. cannot understand the Danish version of the PROM questionnaires
- •Reduced sight in such degree that the participant cannot read the questionnaire in the smartphone app/on the touch-screen with e.g. glasses
研究组 & 干预措施
Group AT
PROM registration via the DANBIO App on a smartphone and thereafter the touch screen solution
干预措施: PROM registration via the touch screen solution (Other)
Group TA
PROM registration via the touch screen solution and thereafter the DANBIO App
干预措施: PROM registration via the DANBIO App on a smartphone (Other)
Group TA
PROM registration via the touch screen solution and thereafter the DANBIO App
干预措施: PROM registration via the touch screen solution (Other)
Group AT
PROM registration via the DANBIO App on a smartphone and thereafter the touch screen solution
干预措施: PROM registration via the DANBIO App on a smartphone (Other)
结局指标
主要结局
Change in Health Assessment Questionnaire (HAQ)
时间窗: day 1 (first data registration) and day 3 (second data registration)
Assess the patient's physical function
次要结局
- Visual Analogue Scale for fatigue(day 1 (first data registration) and day 3 (second data registration))
- Bath Ankylosing Spondylitis Functional Index (BASFI)(day 1 (first data registration) and day 3 (second data registration))
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(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))
- Patient Global Visual Analogue Scale(day 1 (first data registration) and day 3 (second data registration))
- Visual Analogue Scale for Pain(day 1 (first data registration) and day 3 (second data registration))
- Anchoring question(day 1 (first data registration) and day 3 (second data registration))
- Disease Activity Score 28 joints C-reactive protein (DAS28crp)(day 1 (first data registration) and day 3 (second data registration))
- Ankylosing Spondylitis Disease Activity Score (ASDAS)(day 1 (first data registration) and day 3 (second data registration))
研究者
Salome Kristensen
MD, PhD
Aalborg University Hospital