[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654139":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":45,"studyPopulation":46,"armGroups":47,"interventions":41,"overallOfficials":51,"centralContacts":55,"locations":61,"responsibleParty":77,"collaborators":41,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":41,"enrollmentInfo":92,"targetDuration":41,"studyType":95,"phases":41,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":113,"whyStopped":41,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Universiti Sains Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Distribution of Finnish Diabetes Risk Score Categories","Number and percentage of participants classified as low risk below 7, slightly elevated risk from 7 to 11, moderate risk from 12 to 14, high risk from 15 to 20, or very high risk above 20.","Initial community pharmacy visit on Day 0",[14,18,21,25,29,33,37],{"measure":15,"description":16,"timeFrame":17},"General Practitioner Referral Completion Rate","Number and percentage of participants with abnormal pharmacy HbA1c results who attend a general practitioner or primary care facility and complete confirmatory assessment.","Within 3 months after referral",{"measure":19,"description":20,"timeFrame":17},"General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate","Number and percentage of participants with abnormal pharmacy HbA1c results who receive a diagnosis of type 2 diabetes following assessment and laboratory testing by a general practitioner.",{"measure":22,"description":23,"timeFrame":24},"Treatment Initiation After Confirmed Type 2 Diabetes","Number and percentage of participants with GP-confirmed type 2 diabetes who initiate lifestyle management, oral medication, insulin, or combination treatment.","Through 6 months",{"measure":26,"description":27,"timeFrame":28},"Change in HbA1c","Mean change in HbA1c percentage points from the initial community pharmacy measurement to the three-month and six-month measurements among participants with GP-confirmed type 2 diabetes.","Baseline, 3 months, and 6 months",{"measure":30,"description":31,"timeFrame":32},"Pharmacist-Delivered Services","Number and percentage of participants receiving HbA1c result explanation, dietary counselling, physical activity counselling, diabetes risk-reduction advice, GP referral, dietitian referral, physician contact, or appointment support.","Initial visit through 6 months",{"measure":34,"description":35,"timeFrame":36},"Cost per Participant Screened","Total screening costs divided by the number of participants screened. Costs will include test materials, pharmacist time, educational materials, administration, and referral-related resources.","Through completion of the screening phase",{"measure":38,"description":39,"timeFrame":40},"Cost per Confirmed Type 2 Diabetes Case","Total screening and referral costs divided by the number of participants receiving a GP-confirmed diagnosis of type 2 diabetes.","Through 3 months after the final referral",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","PROSPECTIVE","The study uses a two-phase prospective observational cohort design. No medical treatment will be assigned by the research team.\n\nDuring the initial screening phase, trained community pharmacists will administer the Arabic-translated eight-item Finnish Diabetes Risk Score. The score includes age, body mass index, waist circumference, physical activity, fruit and vegetable intake, antihypertensive medication use, history of high blood glucose, and family history of diabetes. Scores will be classified as low risk below 7, slightly elevated risk from 7 to 11, moderate risk from 12 to 14, high risk from 15 to 20, and very high risk above 20.\n\nParticipants with a score of 15 or higher will undergo capillary point-of-care HbA1c testing at the community pharmacy using the Clover A1c analyser. Results will be classified as normal below 5.7%, within the prediabetes range from 5.7% to 6.4%, or within the diabetes range at 6.5% or higher.\n\nAn abnormal pharmacy HbA1c result will not be considered a confirmed diagnosis. These participants will be referred to a general practitioner or primary care facility for clinical assessment and confirmatory laboratory testing. The general practitioner's assessment will determine the final diagnosis and treatment plan.\n\nParticipants with general practitioner-confirmed type 2 diabetes will enter a six-month observational follow-up period. The initial pharmacy HbA1c result will serve as the baseline measurement. HbA1c will be reassessed at three and six months. The research team will document referral completion, diagnostic confirmation, treatment initiation, pharmacist-delivered services, and follow-up findings without directing clinical management.\n\nParticipating pharmacists will complete standardized training and competency assessment before conducting study procedures. Standard operating procedures will guide risk assessment, capillary blood collection, HbA1c testing, result documentation, counselling, referral, and follow-up.","The study population will consist of adults visiting participating community pharmacies in Irbid Governorate, Jordan, who have no previous diagnosis of diabetes. Participants will be recruited through convenience sampling during routine pharmacy visits. Those classified as having a high or very high diabetes risk will receive community pharmacy-based point-of-care HbA1c testing. Participants with GP-confirmed type 2 diabetes will enter the six-month follow-up cohort.",[48],{"label":49,"type":41,"description":50,"interventionNames":41},"Community Pharmacy Visitors Without Diagnosed Diabetes","Adults without a previous diabetes diagnosis will complete FINDRISC screening during a community pharmacy visit. Participants with a score of 15 or higher will receive point-of-care HbA1c testing at the community pharmacy. Those with abnormal HbA1c results will be advised to obtain diagnostic confirmation from a general practitioner or primary care facility. Participants with GP-confirmed type 2 diabetes will enter a six-month follow-up period with HbA1c assessments at three and six months. The study will not assign medical treatment.",[52],{"name":53,"affiliation":5,"role":54},"Rabia Hussain, RPh, PhD","STUDY_CHAIR",[56],{"name":57,"role":58,"phone":59,"phoneExt":41,"email":60},"Khaled M. Alshorman, MSc","CONTACT","+962 79 522 6732","kmssshorman@gmail.com",[62],{"facility":63,"status":41,"city":64,"state":65,"zip":41,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Khaled Pharmacy","Irbid","Irbid Governorate","Jordan","JO",{"type":69,"coordinates":70},"Point",[71,72],35.85,32.55556,{"lat":72,"lon":71},[75],{"name":57,"role":58,"phone":76,"phoneExt":41,"email":60},"+962795226732",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Rabia Hussain","Dr Rabia Hussain, RPh, PhD Senior Lecturer Universiti Sains Malaysia","100654139","predict-dm-community-pharmacy-based-point-of-care-testing-for-undiagnosed-t2dm-100654139",false,"NCT07795918","PREDICT-DM: Community Pharmacy-Based Point-of-Care Testing for Undiagnosed T2DM","PREDICT-DM: Pharmacy-based Rapid Early Detection and Identification of Cases of Type 2 Diabetes Mellitus","PREDICT-DM","Inclusion Criteria:\n\n* Aged 18 years or older\n* Lives in Irbid Governorate, Jordan\n* Visits a participating community pharmacy\n* Has not previously been diagnosed with diabetes\n* Can understand and complete the study procedures\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Previous diagnosis of diabetes\n* Pregnancy\n* Known anemia\n* Known hemoglobin disorder\n* Blood transfusion within the previous three months\n* A condition that may make the HbA1c result inaccurate\n* A cognitive or communication difficulty that prevents informed consent or",true,"ALL","18 Years",{"count":93,"type":94},480,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether community pharmacy-based risk assessment and point-of-care HbA1c testing can help detect undiagnosed type 2 diabetes and prediabetes among adults in Irbid Governorate, Jordan, who have no previous diabetes diagnosis.\n\nThe main questions it aims to answer are:\n\nWhat proportion of participants fall into each Finnish Diabetes Risk Score category? What proportion of participants at high or very high risk have HbA1c results within the prediabetes or diabetes range?\n\nParticipants will:\n\nComplete the Finnish Diabetes Risk Score questionnaire at a community pharmacy. Receive a finger-prick HbA1c test at the pharmacy if their risk score is 15 or higher.\n\nVisit a general practitioner or primary care facility for diagnostic confirmation if their HbA1c result is abnormal.\n\nAttend follow-up assessments at three and six months if a general practitioner confirms type 2 diabetes.",[98,99,100,101],"Diabetes Mellitus, Type 2","Prediabetic State","Prediabetes \u002F Type 2 Diabetes","T2DM",[103,104,105,106,107,108,109,110,111,112,66,87],"Community Pharmacy","Point-of-Care Testing","POCT","HbA1c","Finnish Diabetes Risk Score","FINDRISC","Diabetes Screening","Undiagnosed Diabetes","Early Detection","Pharmacist-Led Screening","NOT_YET_RECRUITING","2026-08-26",{"date":116,"type":117},"2026-08-31","ACTUAL",{"date":119,"type":94},"2026-10-01",{"date":121,"type":94},"2027-05-31",{"name":5,"class":6},1]