[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637172":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":32,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":79,"collaborators":21,"id":81,"slug":21,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":21,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":21,"enrollmentInfo":89,"targetDuration":21,"studyType":92,"phases":21,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":52,"whyStopped":21,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Self-management agency","The level of self-management agency among adult patients with diabetes mellitus, measured using the adapted Appraisal of Self-Care Agency Scale-Revised (ASAS-R).","Baseline (cross-sectional assessment)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Health literacy","Health literacy levels measured using the adapted All Aspects of Health Literacy Scale (AAHLS), including functional, communicative, and critical domains.","At enrollment",{"measure":19,"description":20,"timeFrame":17},"Socio-ecological determinants of diabetes self-management","Socio-ecological determinants measured across individual, interpersonal, organizational, community, and policy levels using a researcher-developed assessment tool.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":6,"timePerspective":23,"maskingInfo":21},"CROSS_SECTIONAL","Diabetes mellitus is a chronic condition requiring sustained self-management behaviors influenced by individual capacities, social support systems, healthcare structures, community resources, and health policies. This observational study adopts the Social Ecological Model and Orem's Self-Care Deficit Theory to evaluate the combined effects of socio-ecological determinants and health literacy on self-management agency.\n\nData will be collected using structured questionnaires, including adapted health literacy and self-care agency scales, along with researcher-developed instruments assessing socio-demographic variables and socio-ecological determinants. Path analysis will be employed to examine direct and indirect relationships among study variables.","Adult patients diagnosed with type 1 or type 2 diabetes mellitus and attending outpatient clinics or primary healthcare centers.",[27],{"label":28,"type":21,"description":29,"interventionNames":30},"Patients with Diabetes Mellitus","Adult patients diagnosed with type 1 or type 2 diabetes mellitus receiving outpatient follow-up care and participating in a cross-sectional observational assessment.",[31],"Other: Questionnaire-based assessment",[33],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":21},"Questionnaire-based assessment","No clinical or behavioral intervention is applied. This observational study involves a questionnaire-based assessment to collect data on socio-ecological determinants, health literacy, and self-management agency among adult patients with diabetes mellitus.",[28],[38],{"name":39,"affiliation":5,"role":40},"Mohamed Fakhry Ahmed Salem","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":21,"email":46},"Mohamed Fakhry Ahmed Salem, phd","CONTACT","+201286038014","Mohamed.Fakhry@alexu.edu.eg",{"name":48,"role":44,"phone":21,"phoneExt":21,"email":46},"Ahmed Salem",[50,70],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Alexandria University Hospital, Faculty of Nursing","RECRUITING","Alexandria","Alexandria Governorate","21511","Egypt","EG",{"type":59,"coordinates":60},"Point",[61,62],29.91582,31.20176,{"lat":62,"lon":61},[65,68],{"name":66,"role":44,"phone":67,"phoneExt":21,"email":46},"Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing","01286038014",{"name":69,"role":40,"phone":21,"phoneExt":21,"email":21},"Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin",{"facility":71,"status":72,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Faculty of Nursing, Alexandria University","NOT_YET_RECRUITING",{"type":59,"coordinates":74},[61,62],{"lat":62,"lon":61},[77,78],{"name":43,"role":44,"phone":67,"phoneExt":21,"email":46},{"name":69,"role":40,"phone":21,"phoneExt":21,"email":21},{"type":40,"investigatorFullName":39,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Lecturer of Medical-Surgical Nursing","100637172",false,"NCT07591103","Socio-Ecological Determinants and Health Literacy: A Path Analysis of Self-Management Agency Among Patients With Diabetes Mellitus","Socio-Ecological Determinants and Health Literacy as Predictors of Self-Management Agency Among Patients With Diabetes Mellitus: A Cross-Sectional Path Analysis Study","Inclusion Criteria:\n\n* \\- Adults aged 18 years and older.\n* Diagnosed with type 1 or type 2 diabetes mellitus.\n* Receiving follow-up care in outpatient or primary healthcare settings.\n* Able to communicate verbally and provide informed consent.\n\nExclusion Criteria:\n\n* \\- Patients with severe cognitive impairment.\n* Patients with acute medical conditions preventing participation.\n* Pregnant women diagnosed with gestational diabetes.","ALL","18 Years",{"count":90,"type":91},400,"ESTIMATED","OBSERVATIONAL","This study aims to examine the relationships between socio-ecological determinants, health literacy, and self-management agency among patients with diabetes mellitus. Using a path analysis framework, the study investigates how multi-level socio-ecological factors and different dimensions of health literacy influence patients' capacity for diabetes self-management. Understanding these pathways will support the development of comprehensive, context-sensitive interventions to improve diabetes outcomes.",[95],"Diabetes Mellitus (Type 1 and Type 2)",[97,98,99,100,101],"Diabetes Mellitus","Health Literacy","Self-Management","Socio-Ecological Determinants","Self-Care Agency","2026-06-04",{"date":104,"type":105},"2026-06-05","ACTUAL",{"date":107,"type":105},"2026-05-15",{"date":109,"type":91},"2026-07-30",{"name":5,"class":6},2]