Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04648956
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arabic Version of the ICOAP Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Content Validity', 'timeFrame': '1 day', 'description': 'Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.'}, {'measure': 'Construct Validity', 'timeFrame': '1 day', 'description': "Assessed by calculating the Spearman's correlation coefficient (ρ) between the Arabic ICOAP (ICOAP-Ar) score and the relevant pain and symptoms score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Hip Injury and Osteoarthritis Outcome Score (HOOS) measurement tools. The coefficient is classified as follows: ρ = 0.3-0.7 moderate correlation, and \\>0.7 strong correlation."}, {'measure': 'Internal Consistency', 'timeFrame': '48-72 hours', 'description': "Assessed by calculating the Cronbach's alpha (α) and the corrected item-total correlation. A Cronbach's α value of ≥0.7, and corrected item-total correlation, measured using the Pearson correlation coefficient, of ≥0.3 will be considered acceptable."}, {'measure': 'Test-retest Reliability', 'timeFrame': '48-72 hours', 'description': 'Assessed by calculating the intraclass correlation coefficient (ICC) between the ICOAP-Ar scores of the first two test sessions. An ICC value of \\>0.8, and 0.6-0.8 will be considered as excellent and good correlation, respectively.'}], 'secondaryOutcomes': [{'measure': 'Responsiveness', 'timeFrame': '4 weeks', 'description': "Participants will be categorized according to their reported Global Rating of Change (GRoC) Scale scores to either improved (GRoC ≥3) or stable group (GRoC \\<3 to \\>-3) and between-group comparison of each group's ICOAP-Ar scores will be performed using unpaired t-test."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICOAP questionnaire', 'Arabic', 'Cross-Cultural adaptation'], 'conditions': ['Knee Osteoarthritis', 'Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A study to translate and cross-culturally adapt the Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool into the Arabic language, and assess its psychometric properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Knee/Hip osteoarthritis patients recruited from the local community receiving physical therapy rehabilitation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).\n\nExclusion Criteria:\n\n1. rheumatoid arthritis\n2. serious pathological conditions (inflammatory arthritis and malignancy)\n3. total or partial arthroplasty of the affected joint\n4. individuals who cannot read and understand documents written in the Arabic language.'}, 'identificationModule': {'nctId': 'NCT04648956', 'briefTitle': 'Arabic Version of the ICOAP Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Prince Sultan Military College of Health Sciences'}, 'officialTitle': 'Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire', 'orgStudyIdInfo': {'id': 'IRB-2020-PT-031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Knee/Hip osteoarthritis', 'description': 'Patients referred for physical therapy rehabilitation', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'Standard treatment', 'type': 'OTHER', 'otherNames': ['ICOAP questionnaire'], 'description': 'Participants shall fill the ICOAP-Ar questionnaire three times within one month in addition to other questionnaires including the KOOS/HOOS, and the Global Rating of Change Scale (GRoC). The first two times will be within a time frame of 48-72 hours. The third time will be after one month.', 'armGroupLabels': ['Knee/Hip osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31932', 'city': 'Dhahran', 'state': 'Eastern Province', 'country': 'Saudi Arabia', 'facility': 'Prince Sultan Military College of Health Sciences', 'geoPoint': {'lat': 26.28864, 'lon': 50.11396}}], 'overallOfficials': [{'name': 'Ahmed Farrag, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince Sultan Military College of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince Sultan Military College of Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Fahd Military Medical Complex', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Ahmed Farrag', 'investigatorAffiliation': 'Prince Sultan Military College of Health Sciences'}}}}