[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551808":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":81,"overallStatus":89,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Yangzhou University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Routine Care","PLACEBO_COMPARATOR","Implementation of routine diabetes health education.",[13],"Behavioral: Routine Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Based on BCW Theory of Health Education","EXPERIMENTAL","A FoH intervention program based on BCW theory was implemented on top of the routine care.",[19],"Behavioral: Based on BCW Theory of Health Education",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Provide patients with regular medication guidance, dietary guidance, exercise guidance and knowledge about diabetes mellitus and hypoglycaemia; test and record blood glucose regularly every day; answer patients' clinical questions and provide psychological support in a timely manner.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"BCW theory was applied to analyse behaviour and develop interventions in terms of capability, motivation and opportunity. Capability: Intensive daily management of diabetes through intervention functions (education, training, persuasion, modelling) to change attitudes and habits, understand the negative consequences of fear of hypoglycaemia, improve hypoglycaemia awareness and self-regulation skills. Opportunity: Through the intervention function (education, training, realization) to improve the awareness of hypoglycemia awareness, timely detection of hypoglycemia. In the event of a hypoglycaemic event patients know how to deal with it. Motivation: Through intervention functions (environmental reconstruction, realisation) that take full account of external factors and their own opportunities. Glucose management through microsoft platforms, on-site teaching and coaching by specialist nurses to create opportunities for patients who can change excessive\u002Favoidant behaviours.",[15],[30],{"name":31,"affiliation":5,"role":32},"Zhao Yueqi, Master","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Ma Hongxin, Master","CONTACT","+86 87974902","007032@yzu.edu.cn",[40],{"facility":5,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Yangzhou","Jiangsu","225000","China","CN",{"type":47,"coordinates":48},"Point",[49,50],119.43583,32.39722,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":25,"phoneExt":37,"email":25},"Hongxin Ma, Master",{"type":32,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Zhao Yueqi","Principal Investigator","100551808","effects-of-a-health-intervention-on-fear-of-hypoglycemia-100551808",false,"NCT06464900","Effects of a Health Intervention on Fear of Hypoglycemia","Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study","Inclusion Criteria:\n\n* Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;\n* Age ≥18 years;\n* Duration of diabetes mellitus ≥1 year;\n* FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);\n* Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;\n* Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;\n* Patients with comorbid psychiatric diseases or taking psychotropic drugs;\n* Patients who have recently or are participating in other studies on similar topics.","ALL","18 Years",{"count":68,"type":69},90,"ESTIMATED","INTERVENTIONAL",[72],"NA","To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.",[75,76,77,78,79,80],"Health-Related Behavior","Health Education","Fear of Hypoglycemia","Impaired Awareness of Hypoglycemia","Self-Management","Type2 Diabetes Mellitus",[82,83,84,85,86,87,88],"Behaviour Change Wheel","Health educational intervention","Fear of hypoglycaemic","Impaired awareness of hypoglycaemia","Medical support","Self-management attitude","Type 2 diabetes mellitus","NOT_YET_RECRUITING","2024-07-07",{"date":92,"type":93},"2024-07-09","ACTUAL",{"date":95,"type":69},"2024-07",{"date":97,"type":69},"2025-01",{"name":5,"class":6},1]