Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT07291492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'European Health Literacy Scale', 'timeFrame': 'post-injury 12th week.', 'description': 'The scale is based on a conceptual framework comprising three health-related domains (treatment, disease prevention, and health promotion) as well as four information-processing stages (accessing, understanding, appraising/decision-making, and applying health information). The instrument contains 47 items rated on a four-point Likert scale.The total score is standardized to range from 0 to 50. Health literacy levels are categorized as follows: (0-25): insufficient, (\\>25-33): problematic-limited, (\\>33-42): sufficient, (\\>42-50): excellent'}, {'measure': 'Michigan Hand Outcomes Questionnaire', 'timeFrame': 'post-injury 12th week', 'description': 'The MHOQ assesses hand and wrist status across six domains: function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction. It consists of 63 items addressing both hands. Each item is scored on a 1-5 scale, and each domain score is converted to a 0-100 scale. Except for the pain domain, higher scores indicate better outcomes'}, {'measure': 'Grip strength', 'timeFrame': 'post-injury 12th week', 'description': 'Grip strength was assessed according to the procedure recommended by the American Society of Hand Therapists. A Jamar dynamometer was used to evaluate gross grip strength. Measurements were performed with the patient seated without elbow support, the arm in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist positioned in approximately 30° extension. Beginning with the dominant hand, measurements were taken on both sides. The mean value of three trials was recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Literacy', 'Functional Outcomes'], 'conditions': ['Hand Injuries', 'Forearm Fractures']}, 'referencesModule': {'references': [{'pmid': '27765527', 'type': 'BACKGROUND', 'citation': 'Roh YH, Lee BK, Park MH, Noh JH, Gong HS, Baek GH. Effects of health literacy on treatment outcome and satisfaction in patients with mallet finger injury. J Hand Ther. 2016 Oct-Dec;29(4):459-464. doi: 10.1016/j.jht.2016.06.004. Epub 2016 Oct 17.'}, {'pmid': '30688895', 'type': 'BACKGROUND', 'citation': "Roy M, Okrainec K, Novak CB, von Schroeder HP, Urbach DR, McCabe SJ. Universal Measures of Support Are Needed: A Cross-Sectional Study of Health Literacy in Patients with Dupuytren's Disease. Plast Reconstr Surg. 2019 Feb;143(2):350e-358e. doi: 10.1097/PRS.0000000000005209."}, {'pmid': '40347201', 'type': 'BACKGROUND', 'citation': 'Miclau KR, Kwong JW, Tapp E, Mulakaluri A; sALLud Consortium; Shapiro LM. Evaluating the Association Between Health Literacy and Patient-Reported Outcome Measures After Distal Radius Fracture. J Hand Surg Am. 2025 May 9:S0363-5023(25)00163-7. doi: 10.1016/j.jhsa.2025.03.022. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://iris.who.int/handle/10665/326432', 'label': 'World Health Organization (WHO). (2016). Health literacy: The solid facts.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the association between health literacy, patient-reported outcome measures, and grip strength in a cohort of patients with hand injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were referred to the hand rehabilitation unit for hand or forearm injuries, aged 18-65 years who voluntarily agreed to participate will be included to the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65 years\n* Voluntarily agreed to participate\n* Presented with hand and/or forearm injuries\n\nExclusion Criteria:\n\n* Concomitant shoulder or elbow injuries\n* History of surgery due to neurological, rheumatological, or metabolic conditions affecting the entire upper extremity\n* Employment in a health-related profession'}, 'identificationModule': {'nctId': 'NCT07291492', 'briefTitle': 'Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Examining the Relationship Between Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries', 'orgStudyIdInfo': {'id': 'E-60116787-020-789611'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hand and/or forearm injuries', 'description': 'Patients aged 18-65 years who voluntarily agreed to participate and who presented with hand and/or forearm injuries', 'interventionNames': ['Other: Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks']}], 'interventions': [{'name': 'Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks', 'type': 'OTHER', 'description': 'Conventional hand therapy will be applied (edema and scar management, exercises) for 12 weeks.', 'armGroupLabels': ['Patients with hand and/or forearm injuries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20070', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'centralContacts': [{'name': 'HANDE USTA OZDEMIR, PhD', 'role': 'CONTACT', 'email': 'husta@pau.edu.tr', 'phone': '+902582965845'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We may share de-identified IPD upon reasonable request and subject to appropriate data-use agreements, provided that sharing aligns with participant consent and institutional policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'HANDE USTA', 'investigatorAffiliation': 'Pamukkale University'}}}}