Clinical trial NCT05661760: Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis
Official title: Development of a Clinical Prediction Model to Facilitate Decision Making in Interdisciplinary Biopsychosocial Rehabilitation in Patients With Osteoarthritis (OA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Osteoarthritis
Disability Physical
Keywords: multimodal treatment
interdisciplinary
rehabilitation medicine
prediction model
treatment outcome
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Centrum voor Integrale Revalidatie (CIR)
name: Pfizer
First posted: 2022-12-22
Enrollment: 2309
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Referred by GP, medical specialist or occupation physician to reduce level of disability and improve quality of life of patients fulfilling the eligibility criteria and not having one or more of the exclusion criteria:

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Disability Index
timeFrame: baseline (start of treatment) and 10 weeks
Secondary outcomes:
Other outcomes:
measure: Brief Illness Perception Questionnaire
timeFrame: Baseline
measure: Pain Self Efficacy Questionnaire
timeFrame: baseline
measure: Psychological Inflexibility in Pain Scale
timeFrame: Baseline
measure: Symptom Checklist 90
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: General CIR questionnaire
timeFrame: baseline
measure: Pain Catastrophising Scale
timeFrame: Baseline
measure: Checklist Individual Strength
timeFrame: Baseline
measure: Twelve-Item Short Form Health Survey
timeFrame: Baseline
measure: Patient Specific Complaint
timeFrame: Baseline
Locations:
city: Zwolle
country: Netherlands
facility: Centrum voor Integrale Revalidatie
state: Overijssel
Study officials:
affiliation: Maastricht University
name: Rob J Smeets, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breugelmans L, Scheffer E, Beckers LWME, Oosterwijk RFA, Nijland G, Smeets RJEM. Systematic description of an interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain, using the TIDieR checklist. BMC Res Notes. 2022 Oct 11;15(1):320. doi: 10.1186/s13104-022-06211-z.