Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 5:52 AM
Study NCT ID:
NCT07330492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Brief Reassurance Message Before a Musculoskeletal Clinic Visit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-28', 'size': 307737, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-29T12:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-04', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-04', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-visit enthusiasm for additional care', 'timeFrame': 'Immediately after intervention', 'description': 'The primary outcome is pre-visit enthusiasm for additional care, measured as participants\' self-reported interest in pursuing a return visit, diagnostic tests, physical therapy, injections, or surgery. Participants rate each item on a 0-10 scale, where 0 indicates "not at all interested" and 10 indicates "definitely want it." This outcome is assessed immediately after the intervention (or usual care) and before the clinic visit.'}], 'secondaryOutcomes': [{'measure': 'Actual scheduled follow-up care', 'timeFrame': 'Immediately following clinic visit', 'description': "The secondary outcomes are actual scheduled follow-up care after the musculoskeletal clinic visit, including return visits, diagnostic tests, physical therapy, injections, and surgery. These outcomes are recorded as yes/no for each type of care and are collected from the patient's medical record after the visit."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Musculoskeletal', 'Osteoarthritis', 'Nudge intervention', 'Behavioural intervention', 'Patient education', 'Healthcare utilization', 'Shared decision making', 'Reassurance'], 'conditions': ['Any Non-traumatic Musculoskeletal Condition']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if a brief, reassuring pre-visit message affects patients' expectations and planned follow-up care in adults with common musculoskeletal conditions. The main questions it aims to answer are:\n\n* Does reading a brief reassurance message before a clinic visit change how interested patients are in additional care, such as follow-up visits, tests, injections, or surgery?\n* Does the message affect whether patients actually schedule follow-up care after the visit?\n\nResearchers will compare participants who receive the pre-visit reassurance message to those who receive usual care to see if the message changes patients' enthusiasm for care or their follow-up decisions.\n\nParticipants will:\n\n1. Read a short, easy-to-understand message about musculoskeletal symptoms and options for care (for those in the intervention group)\n2. Complete a brief questionnaire rating their interest in follow-up visits, tests, injections, or surgery\n3. Have their scheduled follow-up care recorded after the clinic visit"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18+ years)\n* English or Spanish language literacy\n* Seeking musculoskeletal specialty care\n* Diagnosed with any non-traumatic musculoskeletal condition\n* New or return patient to clinic\n\nExclusion Criteria:\n\n* Cognitive or other impairment precluding completion of a survey on a tablet\n* Acute traumatic pathophysiology (fracture, dislocation, sprain/strain)'}, 'identificationModule': {'nctId': 'NCT07330492', 'briefTitle': 'Testing a Brief Reassurance Message Before a Musculoskeletal Clinic Visit', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Randomized Controlled Trial of a Nudge Intervention for Common Musculoskeletal Conditions', 'orgStudyIdInfo': {'id': 'STUDY00004831.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm (Nudge / Reassurance Message)', 'description': "Participants randomized to the intervention group will read a brief, easy-to-understand message (generated by a Large Language Model) before their musculoskeletal clinic visit. The message explains that many musculoskeletal symptoms are common, often related to normal body changes, and can improve with simple self-care. It emphasizes that visits, tests, injections, and treatments are often optional, and patients can decide how much care they wish to pursue. After reading the message, participants will complete a short questionnaire rating their interest in follow-up visits, tests, injections, and surgery. Clinicians providing care will be blinded to participants' group assignment.", 'interventionNames': ['Behavioral: Nudge intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm (Usual Care)', 'description': "Participants randomized to the control group will receive usual care prior to their musculoskeletal clinic visit, without any pre-visit reassurance message. They will complete the same questionnaire rating their interest in follow-up visits, tests, injections, and surgery. Clinicians providing care will be blinded to participants' group assignment."}], 'interventions': [{'name': 'Nudge intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Reassurance message'], 'description': 'The intervention involves reading a brief, easy-to-understand message prior to a musculoskeletal clinic visit. The message explains that many musculoskeletal symptoms are common, often related to normal age-related changes, and can improve with simple self-care. It emphasizes that visits, tests, injections, and treatments are often optional, and patients can choose how much care to pursue.', 'armGroupLabels': ['Intervention Arm (Nudge / Reassurance Message)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'David Ring, MD, PhD', 'role': 'CONTACT', 'email': 'david.ring@austin.utexas.edu', 'phone': '(833) 882-2737'}], 'facility': 'Musculoskeletal Institute, UT Health Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'David Ring, MD, PhD', 'role': 'CONTACT', 'email': 'david.ring@austin.utexas.edu', 'phone': '(833) 882-2737'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean for Comprehensive Care; Professor and Associate Chair for Faculty Academic Affairs, Department of Surgery and Perioperative Care; Courtesy Professor of Psychiatry and Behavioral Sciences', 'investigatorFullName': 'David Ring', 'investigatorAffiliation': 'University of Texas at Austin'}}}}