Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-03-06 @ 7:34 AM
Study NCT ID:
NCT06522906
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobilizing Hispanics With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Educational sessions attended', 'timeFrame': '3 month follow-up', 'description': 'Number of educational sessions attended by patients and partners will be recorded'}, {'measure': 'Adherence with muscle strengthening program', 'timeFrame': '3 month follow-up', 'description': 'Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)".'}, {'measure': 'Adherence with physical activity plan', 'timeFrame': '3 month follow-up', 'description': 'Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop".'}, {'measure': 'Satisfaction with program', 'timeFrame': '3 month follow-up', 'description': 'Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied")'}, {'measure': 'Perceived helpfulness', 'timeFrame': '3 month follow-up', 'description': 'Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not)'}], 'secondaryOutcomes': [{'measure': 'Osteoarthritis disease severity', 'timeFrame': 'Baseline and 3 month follow-up', 'description': 'Severity of OA symptoms will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in two subscale scores (joint pain \\[primary outcome, range 0-20\\] and physical function \\[0-68\\]) will be calculated.'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline and 3 month follow-up', 'description': 'Physical activity will be measured using a pedometer. Participants will be asked to wear a pedometer at the waist for 7 consecutive days to record the number of steps taken per day.'}, {'measure': 'Physical activity (self-report)', 'timeFrame': 'Baseline and 3 month follow-up', 'description': 'Physical activity (self-report) of study dyads in the last week will also be measured using the Physical Activity Scale for the Elderly (range: 0-400, higher scores indicate greater physical activity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hispanic', 'Exercise'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).\n\nHispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.\n\nStudy participants will fill out a survey before the start of the study and 3 months after.', 'detailedDescription': 'Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hispanic/Latino ethnicity\n* ≥ 50 years of age\n* Access to a device with internet connection\n* Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria)\n* Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions\n\nExclusion Criteria:\n\n* Unknown or non-Hispanic ethnicity\n* Condition that prevents ability to provide consent\n* Illness with a life expectancy \\<12 months\n* History of arthroplasty or prosthetic leg\n* Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout)\n* Condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)'}, 'identificationModule': {'nctId': 'NCT06522906', 'briefTitle': 'Mobilizing Hispanics With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '00004081'}, 'secondaryIdInfos': [{'id': '991639', 'type': 'OTHER_GRANT', 'domain': 'Rheumatology Research Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads', 'interventionNames': ['Behavioral: Muscle Strengthening', 'Behavioral: General Physical Activity', 'Behavioral: Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Treatment only includes live video educational sessions about OA', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Muscle Strengthening', 'type': 'BEHAVIORAL', 'description': 'Patients will be offered five video consultations (30-45 minutes each) with a physical therapist over 3 months. The physical therapist will prescribe an exercise program individualized to the OA patient that will include strengthening exercises (2 quadriceps, 1 hip/gluteal, 1 hamstrings/gluteal, 1 calf, and 1 other) to be performed at home 3x/week.', 'armGroupLabels': ['Intervention']}, {'name': 'General Physical Activity', 'type': 'BEHAVIORAL', 'description': 'The general program will consist of four 60-minute live video consultations conducted by a promotora. The first three sessions will be conducted every 2 weeks, with a booster session occurring one month later. The promotora will help dyads set achievable personalized physical activity goals.', 'armGroupLabels': ['Intervention']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Administered by a promotora, treatment will include 4 live video educational sessions about OA', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85713', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jazmin Dagnino', 'role': 'CONTACT', 'email': 'jazmindagnino@arizona.edu', 'phone': '(520) 626-5026'}, {'name': 'Ernest Vina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'centralContacts': [{'name': 'Jazmin Dagnino', 'role': 'CONTACT', 'email': 'jazmindagnino@arizona.edu', 'phone': '(520) 621-6823'}, {'name': 'Ernest Vina, MD', 'role': 'CONTACT', 'email': 'evina@arizona.edu', 'phone': '(520) 626-1613'}], 'overallOfficials': [{'name': 'Ernest Vina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Temple University', 'class': 'OTHER'}, {'name': 'University of Melbourne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}