[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596203":3},{"organization":4,"outcomesModule":7,"designInfo":191,"detailedDescription":192,"studyPopulation":195,"armGroups":192,"interventions":192,"overallOfficials":196,"centralContacts":201,"locations":210,"responsibleParty":243,"collaborators":247,"id":250,"slug":192,"hasResults":251,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":192,"eligibilityCriteria":255,"healthyVolunteers":251,"sex":256,"minAge":257,"maxAge":192,"enrollmentInfo":258,"targetDuration":192,"studyType":261,"phases":192,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":213,"whyStopped":192,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":36},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Self-care in diabetes [1]","The Self-Care of Diabetes Inventory (SCODI) is the self-report tool used to measure self-care dimensions: self-care maintenance, self-care monitoring, and self-care management.The self-care maintenance scale measures adherence to main diabetes treatments (i.e. medication, diet exercise). The self-care monitoring scale includes body listening behaviours, such as blood glucose or blood pressure monitoring and symptom recognition behaviours. The self-care management scale includes those behaviours performed by patients to manage symptoms, high or low blood glucose levels, and health problems when they occur. Furthermore, the SCODI allows to measure self-care confidence that is the degree of confidence a patient has in her\u002Fhis ability to perform adequate self-care. A 5-points Likert type scale measures every item of the SCODI. All the SCODI scales provide a 0-100 standardized score where higher scores mean better self-care.","The SCODI will be administered at the following time point: T0 - Baseline.",{"measure":14,"description":11,"timeFrame":15},"Self-care in diabetes [2]","The SCODI will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days",{"measure":17,"description":11,"timeFrame":18},"Self-care in diabetes [3]","The SCODI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.",{"measure":20,"description":11,"timeFrame":21},"Self-care in diabetes [4]","The SCODI will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.",{"measure":23,"description":11,"timeFrame":24},"Self-care in diabetes [5]","The SCODI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.",[26,30,33],{"measure":27,"description":28,"timeFrame":29},"Glycated Hemoglobin (HbA1c) [1]","Blood glycated hemoglobin measured in both mmol\u002Fmol and % was used as an index of patients' glycemic control.","The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.",{"measure":31,"description":28,"timeFrame":32},"Glycated Hemoglobin (HbA1c) [2]","The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.",{"measure":34,"description":28,"timeFrame":35},"Glycated Hemoglobin (HbA1c) [3]","The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",[37,41,44,47,51,54,57,61,65,69,73,76,79,83,87,90,93,97,100,103,107,111,115,119,122,125,129,132,135,139,142,145,149,152,155,158,161,165,168,171,175,178,181,185,188],{"measure":38,"description":39,"timeFrame":40},"Lipidic profile [1]","Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg\u002FdL.","The lipidic profile will be collected from medical records at the following time point: T0 - Baseline.",{"measure":42,"description":39,"timeFrame":43},"Lipidic profile [2]","The lipidic profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":45,"description":39,"timeFrame":46},"Lipidic profile [3]","The lipidic profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":48,"description":49,"timeFrame":50},"Creatinine [1]","Blood concentration of Creatinine measured in mg\u002FdL.","Creatinine blood level will be collected from medical records at the following time point: T0 - Baseline.",{"measure":52,"description":49,"timeFrame":53},"Creatinine [2]","Creatinine blood level will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":55,"description":49,"timeFrame":56},"Creatinine [3]","Creatinine blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":58,"description":59,"timeFrame":60},"Estimated Glomerular Filtration Rate (GFR) [1]","GFR estimation measured in mL\u002Fmin\u002F1.73m² from age, gender, and blood creatinine \\[1\\] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula.","GFR will be collected from medical records at the following time point: T0 - Baseline.",{"measure":62,"description":63,"timeFrame":64},"Estimated Glomerular Filtration Rate (GFR) [2]","GFR estimation measured in mL\u002Fmin\u002F1.73m² from age, gender, and blood creatinine \\[2\\] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula.","GFR will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":66,"description":67,"timeFrame":68},"Estimated Glomerular Filtration Rate (GFR) [3]","GFR estimation measured in mL\u002Fmin\u002F1.73m² from age, gender, and blood creatinine \\[3\\] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula.","GFR will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":70,"description":71,"timeFrame":72},"Liver profile [1]","Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U\u002FL.","The liver profile will be assessed at the following time point: T0 - Baseline.",{"measure":74,"description":71,"timeFrame":75},"Liver profile [2]","The liver profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":77,"description":71,"timeFrame":78},"Liver profile [3]","The liver profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":80,"description":81,"timeFrame":82},"Height","The height measured in meters.","The height will be measured at following time point: T0 - Baseline.",{"measure":84,"description":85,"timeFrame":86},"Weight [1]","The weight detected on the scale during the visit and measured in kg.","The weight will be measured at the following time point: T0 - Baseline.",{"measure":88,"description":85,"timeFrame":89},"Weight [2]","The weight will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":91,"description":85,"timeFrame":92},"Weight [3]","The weight will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":94,"description":95,"timeFrame":96},"Abdominal circumference [1]","Abdominal circumference measurement in cm.","Abdominal circumference will be measured at the following time point: T0 - Baseline",{"measure":98,"description":95,"timeFrame":99},"Abdominal circumference [2]","Abdominal circumference will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":101,"description":95,"timeFrame":102},"Abdominal circumference [3]","Abdominal circumference will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":104,"description":105,"timeFrame":106},"Body Mass Index (BMI) [1]","The BMI measured in kg\u002Fm² from height and weight \\[1\\].","The BMI will be estimated at the following time point: T0 - Baseline.",{"measure":108,"description":109,"timeFrame":110},"Body Mass Index (BMI) [2]","The BMI measured in kg\u002Fm² from height and weight \\[2\\].","The BMI will be estimated at the following time point: T1 - Month 12 ± 28 days.",{"measure":112,"description":113,"timeFrame":114},"Body Mass Index (BMI) [3]","The BMI measured in kg\u002Fm² from height and weight \\[3\\].","The BMI will be estimated at the following time point: T2 - Month 24 ± 28 days.",{"measure":116,"description":117,"timeFrame":118},"Blood pressure [1]","The systolic and diastolic blood pressure measured di mmHg.","The blood pressure will be measured at the following time point: T0 - Baseline.",{"measure":120,"description":117,"timeFrame":121},"Blood pressure [2]","The blood pressure will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":123,"description":117,"timeFrame":124},"Blood pressure [3]","The blood pressure will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":126,"description":127,"timeFrame":128},"Pulse rate [1]","The pulse rate measured in beats per minute (bpm).","The pulse rate will be measured at the following time point: T0 - Baseline.",{"measure":130,"description":127,"timeFrame":131},"Pulse rate [2]","The pulse rate will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":133,"description":127,"timeFrame":134},"Pulse rate [3]","The pulse rate will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"measure":136,"description":137,"timeFrame":138},"Short Form 12 (SF-12) [1]","The SF-12 evaluates the functional and mental well-being status. It has a 4 week retrospective span and inquires personal and social discomfort disabilities and self-description of the level of health perceived. It can be self-administered and it counts 12 items.","The SF-12 will be administered at the following time point: T0 - Baseline.",{"measure":140,"description":137,"timeFrame":141},"Short Form 12 (SF-12) [2]","The SF-12 will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.",{"measure":143,"description":137,"timeFrame":144},"Short Form 12 (SF-12) [3]","The SF-12 will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.",{"measure":146,"description":147,"timeFrame":148},"EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [1]","The EQ-5D-3L is a self-report tool, composed of 5 items of multiple questions that investigate the quality of life. Questions are about movement, hygiene, daily living activities tolerance, pain\u002Fdiscomfort, and anxiety\u002Fdepression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients","The EQ-5D-3L will be administered at the following time points: T0 - Baseline.",{"measure":150,"description":147,"timeFrame":151},"EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [2]","The EQ-5D-3L will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days.",{"measure":153,"description":147,"timeFrame":154},"EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [3]","The EQ-5D-3L will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.",{"measure":156,"description":147,"timeFrame":157},"EQ-5D-3L [4]","The EQ-5D-3L will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.",{"measure":159,"description":147,"timeFrame":160},"EQ-5D-3L [5]","The EQ-5D-3L will be administered at the following time point: T2 - Month 24 ± 28 days.",{"measure":162,"description":163,"timeFrame":164},"Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [1]","The PAID-5 is composed by 5 items and it can be self-administered. It has satisfactory sensitivity and specificity for recognition of diabetes-related emotional distress. The final score is between 0 and 100 points: a score higher than 40 points has been significantly associated to development of depression and other negative psychological outcomes.","The PAID-5 will be administered at the following time point: T0 - Baseline.",{"measure":166,"description":163,"timeFrame":167},"Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [2]","The PAID-5 will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.",{"measure":169,"description":163,"timeFrame":170},"Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [3]","The PAID-5 will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.",{"measure":172,"description":173,"timeFrame":174},"Pittsburgh Sleep Quality Index (PSQI) [1]","The Pittsburgh Sleep Quality Index is a tool for assessing sleep quality. It comprises 19 items and it is self-administered. It provides a good and reliable differentiation between normal and pathological groups, with higher scores (cut-off 5 and higher) reported by people characterised by more impaired sleep quality.","The PSQI will be administered at the following time point: T0 - Baseline.",{"measure":176,"description":173,"timeFrame":177},"Pittsburgh Sleep Quality Index (PSQI) [2]","The PSQI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.",{"measure":179,"description":173,"timeFrame":180},"Pittsburgh Sleep Quality Index (PSQI) [3]","The PSQI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.",{"measure":182,"description":183,"timeFrame":184},"Events [1]","Any referral or unplanned diabetes visit, request for home care assistance, hospitalisation, access to emergency care, death, received diabetes education in the last year.","Events will be assessed at the following time point: T0 - Baseline.",{"measure":186,"description":183,"timeFrame":187},"Events [2]","Events will be assessed by telephone and collected from medical records at the following time point: T1 - Month 12 ± 28 days.",{"measure":189,"description":183,"timeFrame":190},"Events [3]","Events will be assessed by telephone and collected from medical records at the following time point: T2 - Month 24 ± 28 days.",{"allocation":192,"interventionModel":192,"interventionModelDescription":192,"primaryPurpose":192,"observationalModel":193,"timePerspective":194,"maskingInfo":192},null,"COHORT","PROSPECTIVE","The sample will be enrolled among diabetic patients who access hospital diabetes outpatient clinics in Lombardy (a region in the North of Italy)",[197],{"name":198,"affiliation":199,"role":200},"Davide LL Ausili","Università degli Studi di Milano - Bicocca","STUDY_DIRECTOR",[202,206],{"name":198,"role":203,"phone":204,"phoneExt":192,"email":205},"CONTACT","+39 0264488032","davide.ausili@unimib.it",{"name":207,"role":203,"phone":208,"phoneExt":192,"email":209},"Michela Luciani","+39 0264488168","michela.luciani@unimib.it",[211,229],{"facility":212,"status":213,"city":214,"state":215,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":224,"contacts":225},"IRCCS Policlinico San Donato","RECRUITING","San Donato Milanese","Milan","20097","Italy","IT",{"type":220,"coordinates":221},"Point",[222,223],9.26838,45.41047,{"lat":223,"lon":222},[226],{"name":227,"role":203,"phone":192,"phoneExt":192,"email":228},"Rosario Caruso, RN, PhD","rosario.caruso@grupposandonato.it",{"facility":230,"status":213,"city":231,"state":232,"zip":233,"country":217,"countryCode":218,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Fondazione IRCCS San Gerardo dei Tintori","Monza","Monza Brianza","20900",{"type":220,"coordinates":235},[236,237],9.27246,45.58005,{"lat":237,"lon":236},[240],{"name":241,"role":203,"phone":192,"phoneExt":192,"email":242},"Elena Annoni, RN","elena.annoni@irccs-sangerardo.it",{"type":244,"investigatorFullName":245,"investigatorTitle":246,"investigatorAffiliation":5,"oldNameTitle":192,"oldOrganization":192},"PRINCIPAL_INVESTIGATOR","Davide Ausili","Associate Professor of Nursing Science",[248],{"name":249,"class":6},"IRCCS Policlinico S. Donato","100596203",false,"NCT07042399","Self-care Behaviors of Type 2 Diabetes Mellitus Patients","Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes;\n* Age over 18 years old;\n* Adequate comprehension of the Italian language;\n* Signed and dated informed consent.\n\nExclusion Criteria:\n\n* Presence of documented psychiatric or neurodegenerative disease;\n* Pregnancy;\n* Any condition that, by the investigators' judgment, may limit adherence to study procedures","ALL","18 Years",{"count":259,"type":260},300,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to explore the experience of the chronic disease, with a particular focus on self-care, in adults with type 2 diabetes mellitus. The main questions it aims to answer are:\n\n* what is the association between self-care and glycated hemoglobin over time?\n* what are participants' clinical and sociodemographic characteristics influencing self-care behaviors? Participants' socio-demographic and clinical data will be collected by medical records and, at the beginning or at the end of the clinical standard outpatient visit, they will be asked to complete study questionnaires.\n\nThe results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.",[264],"Type 2 Diabetes",[266,267,268,269],"Self-care","Chronic diseases","Type 2 diabetes","Self-management","2025-06-19",{"date":272,"type":273},"2025-06-29","ACTUAL",{"date":275,"type":273},"2024-03-01",{"date":277,"type":260},"2027-05-31",{"name":5,"class":6},2]