Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 6:17 AM
Study NCT ID:
NCT05661760
Status:
UNKNOWN
Last Update Posted:
2022-12-22
First Post:
2022-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brief Illness Perception Questionnaire', 'timeFrame': 'Baseline', 'description': 'Measures the cognitive and emotional representation of illness in a patient'}, {'measure': 'Pain Self Efficacy Questionnaire', 'timeFrame': 'baseline', 'description': 'Measures how confident the patient is that he/she will be able to perform daily tasks despite being in pain'}, {'measure': 'Psychological Inflexibility in Pain Scale', 'timeFrame': 'Baseline', 'description': 'Measures psychological inflexibility (avoidance of pain and cognitive fusion with pain)'}, {'measure': 'Symptom Checklist 90', 'timeFrame': 'Baseline', 'description': 'Measures to which degree the patient suffers from 90 different physical and psychological symptoms.'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Baseline', 'description': 'Measures feelings of fear and depression, without looking at physical complaints'}, {'measure': 'General CIR questionnaire', 'timeFrame': 'baseline', 'description': 'Records general socio-demographic characteristics as well as symptom-related information, co-morbidity and medication levels.'}, {'measure': 'Pain Catastrophising Scale', 'timeFrame': 'Baseline', 'description': 'Measures degree of catastrophizing'}, {'measure': 'Checklist Individual Strength', 'timeFrame': 'Baseline', 'description': 'Measures subjective tiredness'}, {'measure': 'Twelve-Item Short Form Health Survey', 'timeFrame': 'Baseline', 'description': 'Measures physical and mental functioning'}, {'measure': 'Patient Specific Complaint', 'timeFrame': 'Baseline', 'description': "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"}], 'primaryOutcomes': [{'measure': 'Pain Disability Index', 'timeFrame': 'baseline (start of treatment) and 10 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multimodal treatment', 'interdisciplinary', 'rehabilitation medicine', 'prediction model', 'treatment outcome'], 'conditions': ['Chronic Pain', 'Osteoarthritis', 'Disability Physical']}, 'referencesModule': {'references': [{'pmid': '36221116', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nUsing 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.\n\nWith these data a prediction model will be build and internal validation with bootstrapping will be done.', 'detailedDescription': 'Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed.\n\nResearch 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).\n\nDesign: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months.\n\nIntervention 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.\n\nMeasurements: 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.\n\nExpected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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:', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic musculoskeletal pain \\> 3 months and osteoarthritis\n* Large personal and social dysfunction\n* Interplay of biological, social and psychological factors maintaining pain and/or disability\n\nExclusion criteria:\n\n* Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments)\n* Disagreement between patient and care providers on content of treatment\n* Pending legal procedures that hinder full cooperation'}, 'identificationModule': {'nctId': 'NCT05661760', 'acronym': 'CIR-predict', 'briefTitle': 'Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'Development of a Clinical Prediction Model to Facilitate Decision Making in Interdisciplinary Biopsychosocial Rehabilitation in Patients With Osteoarthritis (OA)', 'orgStudyIdInfo': {'id': 'CIR-001'}, 'secondaryIdInfos': [{'id': '41150323011N', 'type': 'OTHER', 'domain': 'CAPHRI-Maastricht University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic pain osteoarthritis', 'description': 'Patients with chronic pain and disability with osteoarthritis', 'interventionNames': ['Behavioral: interdisciplinary multimodal pain treatment']}], 'interventions': [{'name': 'interdisciplinary multimodal pain treatment', 'type': 'BEHAVIORAL', 'otherNames': ['biopsychosocial treatment'], 'description': '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.', 'armGroupLabels': ['chronic pain osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8025 AX', 'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Centrum voor Integrale Revalidatie', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Rob J Smeets, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'As data are gathered as routine practice, data are owned by and stored by CIR. In case of any request the PI can be contacted and he will ask CIR whether specific data will be made available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centrum voor Integrale Revalidatie (CIR)', 'class': 'UNKNOWN'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}