Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-28 @ 4:59 AM
Study NCT ID:
NCT07194759
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-26
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Literacy Levels of Patients Living With Type 2 Diabetes and Multi-disease and Their Families Using HLQTM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000071069', 'term': 'Multiple Chronic Conditions'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Literacy Questionnaire (HLQ)', 'timeFrame': 'At Enrollment', 'description': "The Health Literacy Questionnaire (HLQ) is a 44-item validated questionnaire on health literacy. It consists of two parts, one part with 23 questions answered with a 4-point Likert Scale (strongly disagree = 1, disagree = 2, agree = 3, and strongly agree = 4). The second part has 21 questions answered with a 5-point Likert Scale (can't do/always difficult = 1, usually difficult = 2, sometimes difficult = 3, usually easy = 4, always easy = 5). The patient must select one of the scales for each of the 44 questions.\n\nThe answers are self-reported via REDCap, one time after the survey is distributed."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Outpatients', 'Socioeconomic factors', 'Multiple chronic conditions', 'Family'], 'conditions': ['Health Literacy']}, 'descriptionModule': {'briefSummary': 'This study aims to identify health literacy strengths and needs among people living with type 2 diabetes and multi-disease and their family members.', 'detailedDescription': "Living with diabetes and multi-disease affects not only the individual but also the social network around the person, as self-management is dependent on the ability to change one's lifestyle and manage the consequences of disease. In other words, health literacy strengths and needs of the individual and family members are determinants of how people manage living with type 2 diabetes. Thus, we hypothesise that diabetes management is influenced by the patient's and family members' health literacy. Knowledge about their health literacy could further enhance a patient- and family-centred approach to diabetes treatment and care, improving self-management and promoting health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetes patients and/or family members from four university hospitals in the Region of Southern Denmark. The patients will be invited to participate when they receive a questionnaire. This questionnaire is designed to provide participant information and consent prior to the sociodemographic questions and the health literacy questionnaire.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living with Type 2 diabetes and multi-disease\n* cognitively able to participate\n* following an outpatient care program\n\nExclusion Criteria:\n\n* patients in palliative care\n* inability to read or speak Danish'}, 'identificationModule': {'nctId': 'NCT07194759', 'briefTitle': 'Health Literacy Levels of Patients Living With Type 2 Diabetes and Multi-disease and Their Families Using HLQTM', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Patient and Family Health Literacy - a Survey Among 5000 People', 'orgStudyIdInfo': {'id': 'SHS-MS-1-2025'}}, 'contactsLocationsModule': {'locations': [{'zip': '6200', 'city': 'Aabenraa', 'state': 'Southern Denmark', 'country': 'Denmark', 'facility': 'Sygehus Sønderjylland', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}], 'overallOfficials': [{'name': 'Frans Brandt Kristensen', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Southern Denmark, Hospital Sønderjylland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}