Development of a Clinical Prediction Model to Facilitate Decision Making in Interdisciplinary Biopsychosocial Rehabilitation in Patients With Osteoarthritis (OA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,309
- 试验地点
- 1
- 主要终点
- Pain Disability Index
研究概览
简要总结
The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful.
Using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used.
With these data a prediction model will be build and internal validation with bootstrapping will be done.
详细描述
Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed.
Research Question/Objective: The overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with OA. The model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success).
Design: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months.
Intervention and procedures: The intervention of interest is interdisciplinary biopsychosocial rehabilitation. The procedures include the development of a clinical prediction model and assessment of its performance and internal validity.
Measurements: Candidate predictors will be carefully selected. The outcome of the model will be treatment success, defined by the change on the Pain Disability Index (PDI). The model will be built with data gathered as part of routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic musculoskeletal pain > 3 months and osteoarthritis
- •Large personal and social dysfunction
- •Interplay of biological, social and psychological factors maintaining pain and/or disability
- •Exclusion criteria:
- •Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments)
- •Disagreement between patient and care providers on content of treatment
- •Pending legal procedures that hinder full cooperation
排除标准
- 未提供
结局指标
主要结局
Pain Disability Index
时间窗: baseline (start of treatment) and 10 weeks
Measures to which degree pain prevents the patient from participating in daily activities. Improvement equal or higher than Minimal Clinically Important Change (MCID; which is 9 points) is defined as successful treatment, and all others as not successful treatment Population will be dichotomized into successful or non-successful treatment and this will be the dependent variable for the logistic regression analysis used to build the prediction model
次要结局
未报告次要终点