Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA): Implementation of PsOWellTM in PsA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
This will be a single-arm interventional study to test the acceptability, feasibility, and effectiveness of structured telemedicine visits to encourage lifestyle changes that will improve quality of life, disease impact, and disease activity in patients with psoriatic arthritis (PsA).
详细描述
The proposed trial will be embedded within clinical care. This is a 2-year interventional trial that will enroll patients with active psoriatic arthritis despite stable therapy among three centers (the University of Pennsylvania, University of Utah, and University of Oxford). The intervention employs PsOWellTM, a program that trains clinicians to utilize motivational interviewing to help patients set goals and make lifestyle/behavior changes for holistic management of psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As a pilot study to understand implementation barriers, assess feasibility, and effectiveness, this study is not blinded or randomized.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population: Patients with Psoriatic Arthritis
- •Active symptoms of PsA as defined by a PsA Impact of Disease (PsAID) questionnaire score >4 (range 0-10, 4 is the patient acceptable symptom state) or a patient global assessment of greater than 4 (scale 0-10).
- •Patients should be stable on therapy (i.e., not planning to switch therapy at the current visit).
- •Meet CASPAR criteria.
- •Provision of signed and dated informed consent form.
- •Willingness to comply with all study procedures and availability for duration of the study.
- •Has access to a mobile phone or other mobile device.
排除标准
- •Inability to provide informed consent.
- •Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks.
- •PsAID score ≤4
研究组 & 干预措施
Interventional Telemedicine Arm
Single Arm Intervention
干预措施: Telemedicine (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 4 Months
Patient satisfaction as assessed by Acceptability of Intervention Measure (AIM). The range of this measure is 4-20 where higher scores indicate greater acceptability and satisfaction
Effectiveness
时间窗: 4 Months
Effectiveness as measured by the Psoriatic Arthritis Impact of Disease 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status.
Minimal Disease Activity
时间窗: 4 Months
Minimal Disease Activity (MDA) Composite Score. MDA measures the state of the patient's disease activity. Achievement of MDA means attaining 5/7 of the following: Swollen Joint Count (SJC) ≤1, Tender Joint Count (TJC) ≤1, Enthesitis ≤1, Psoriasis Body Surface Area (BSA) ≤3%, Patient Global Assessment ≤ 20 (0-100), Patient Pain ≤ 20 (0-100), and Health Assessment Questionnaire (HAQ) \<0.05 (0-3). It is a patient-reported and physician-assessed outcome.
次要结局
未报告次要终点