CIR-predict: Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Expected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| chronic pain osteoarthritis Patients with chronic pain and disability with osteoarthritis |
Behavioral: interdisciplinary multimodal pain treatment
A combination of physical and psychosocial treatment methods is employed, including Emotional Awareness and Expression Therapy (EAET), Pain Neuroscience Education (PNE), Acceptance and Commitment Therapy (ACT), graded activity, exposure in vivo, and experiential learning through physical training.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain Disability Index [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
Other Outcome Measures
- Brief Illness Perception Questionnaire [Baseline]
Measures the cognitive and emotional representation of illness in a patient
- Pain Self Efficacy Questionnaire [baseline]
Measures how confident the patient is that he/she will be able to perform daily tasks despite being in pain
- Psychological Inflexibility in Pain Scale [Baseline]
Measures psychological inflexibility (avoidance of pain and cognitive fusion with pain)
- Symptom Checklist 90 [Baseline]
Measures to which degree the patient suffers from 90 different physical and psychological symptoms.
- Hospital Anxiety and Depression Scale [Baseline]
Measures feelings of fear and depression, without looking at physical complaints
- General CIR questionnaire [baseline]
Records general socio-demographic characteristics as well as symptom-related information, co-morbidity and medication levels.
- Pain Catastrophising Scale [Baseline]
Measures degree of catastrophizing
- Checklist Individual Strength [Baseline]
Measures subjective tiredness
- Twelve-Item Short Form Health Survey [Baseline]
Measures physical and mental functioning
- Patient Specific Complaint [Baseline]
Measures a patient's functional status by inquiring for three self-selected daily activities to which degree the patient is limited in this activity by his/her pain complaints
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centrum voor Integrale Revalidatie | Zwolle | Overijssel | Netherlands | 8025 AX |
Sponsors and Collaborators
- Maastricht University
- Centrum voor Integrale Revalidatie (CIR)
- Pfizer
Investigators
- Principal Investigator: Rob J Smeets, MD PhD, Maastricht University
Study Documents (Full-Text)
None provided.More Information
Publications
- CIR-001
- 41150323011N