NCT03099668已完成不适用
The Multidisciplinary Team: Truly Beneficial or Just the Flavour of the Day?A Randomized Controlled Study to Study Outcomes From MDT Care in Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- European Quality of Life-5 Dimension 3 Level (EQ-5D) index at 6 months
研究概览
简要总结
A randomised study of multidisciplinary care (MDT) versus routine care in patients with rheumatoid arthritis (RA). Patients with RA are randomised either to a single visit to a "one Stop Arthritis Clinic' (OSAC) or to see their usual rheumatologists. Data are collected at the baseline visit, and again at subsequent clinic visits (approximately 3 and 6 months). Outcomes such as quality of life, disease activity, physical function, disease specific knowledge, coping and self efficacy are evaluated. Assessment of comorbidities and preventative care (cancer screening, vaccinations, cardiovascular risk assessment and optimisation) are also assessed between the 2 arms.
详细描述
Hypotheses
- Holistic review by a multidisciplinary team leads to improved outcomes such as improved disease activity, physical function and quality of life (QOL) in patients with rheumatoid arthritis (RA).
- These improved outcomes are likely mediated via improvements in medication adherence, coping, disease specific knowledge and improved self-efficacy.
- A "One Stop Arthritis Clinic" (OSAC) where patients are seen by a multidisciplinary team co-located in time and space, is an effective solution to delivering multidisciplinary care.
Specific aims Primary: To determine whether a multidisciplinary review, as compared to routine review by the treating rheumatologist, leads to improved QOL as measured by the European Quality of Life-5 Dimension 3 Level (EQ-5D) index at 6 months in patients with RA with deemed stable disease activity.
Secondary:
- To examine the effect of the multidisciplinary review, as compared to routine rheumatologist review on RA disease activity (measured using the disease activity score in 28 joints, DAS28), pain (measured using a 100mm visual analogue scale (VAS), and physical function (measured using the modified Health Assessment Questionnaire, mHAQ).
- To examine the effect of the multidisciplinary review, as compared to routine rheumatologist review on several secondary measures including self-efficacy (as measured using the Rheumatoid Arthritis Self Efficacy, RASE), Disease Specific Knowledge (DSK) using a Patient Knowledge Questionnaire (PKC), coping, medication adherence (using the Medication Adherence Report Scale (MARS) questionnaire, pill counts and adherence proportion percentage) and Patient Acceptable Symptom State (PASS)
- To examine the effect of the multidisciplinary review, as compared to routine rheumatologist review on patient experience
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Joint counts at 3 and 6 months will be done by a blinded investigator
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rheumatoid arthritis, at least 21 years old, being seen at the rheumatology clinic at the National University Hospital, Singapore
排除标准
- •Patients who are pregnant, are unable to give informed consent, or have previously visited the One Stop Arthritis Clinic
研究组 & 干预措施
OSAC
Experimental
Single visit to a multidisciplinary clinic (the One Stop Arthritis Clinic, OSAC), followed by routine care
干预措施: Visit to a multidisciplinary clinic (Other)
Routine care
No Intervention
Routine care
结局指标
主要结局
European Quality of Life-5 Dimension 3 Level (EQ-5D) index at 6 months
时间窗: 6 months
Quality of life
次要结局
- Days off work (patient)(6 months)
- Proportion of patients in clinical remission or low RA disease activity (measured using the disease activity score in 28 joints, DAS28) (remission = DAS28 ≤ 2.6, low disease activity = DAS28 > 2.6 & ≤ 3.2)(6 months)
- Pain (measured using a 100mm visual analogue (VAS) scale(3 months)
- Physical function (measured using the modified Health Assessment Questionnaire, mHAQ).(6 months)
- Self-efficacy (measured using the Rheumatoid Arthritis Self Efficacy, RASE)(3 months)
- Disease Specific Knowledge (DSK) using a Patient Knowledge Questionnaire (PKC)(3 months)
- Coping - measured using a 100mm visual analogue scale answer to a single question "Considering your arthritis overall, how well did you cope (manage, deal, make do) with your disease during the last week ?"(3 months)
- Medication adherence (using the MARS questionnaire and pill count to calculate medication adherence proportion percentage)(3 months)
- Patient Acceptable Symptom Score (PASS)(6 months)
- Patient experience (using the standard hospital electronic patient experience survey, e-PES)(3 months)
- Foot pain (using the Manchester foot disability index, MFI)(3 months)
- Proportion of patients who achieve adherence to guidelines for vaccination(6 months)
- Proportion of patients who achieve adherence to guidelines for cardiovascular risk management(6 months)
- Proportion of patients who achieve adherence to guidelines for bone health optimisation(6 months)
- Proportion of patients who achieve adherence to guidelines for cancer screening(6 months)
- Utilisation of healthcare resources (clinic visits, laboratory, imaging, procedures, prescriptions, calls to the nurse helpline) measured as total dollar cost (from the hospital perspective)(6 months)
- Days off work (caregiver)(6 months)
- Hours per week in productive paid or unpaid work (patient)(6 months)
- Hours per week in productive paid or unpaid work (caregiver)(6 months)
研究者
研究点 (1)
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