Self-care Behaviors of Type 2 Diabetes Mellitus Patients
NCT ID: NCT07042399
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-03-01
2027-05-31
Brief Summary
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* what is the association between self-care and glycated hemoglobin over time?
* 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.
The results of this study could be helpful in providing quality assistance, improving resource consumption, and reducing the onset of complications.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years old;
* Adequate comprehension of the Italian language;
* Signed and dated informed consent.
Exclusion Criteria
* Pregnancy;
* Any condition that, by the investigators' judgment, may limit adherence to study procedures
18 Years
ALL
No
Sponsors
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IRCCS Policlinico S. Donato
OTHER
University of Milano Bicocca
OTHER
Responsible Party
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Davide Ausili
Associate Professor of Nursing Science
Principal Investigators
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Davide LL Ausili
Role: STUDY_DIRECTOR
Università degli Studi di Milano - Bicocca
Locations
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IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza Brianza, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Riegel B, Dunbar SB, Fitzsimons D, Freedland KE, Lee CS, Middleton S, Stromberg A, Vellone E, Webber DE, Jaarsma T. Self-care research: Where are we now? Where are we going? Int J Nurs Stud. 2021 Apr;116:103402. doi: 10.1016/j.ijnurstu.2019.103402. Epub 2019 Aug 23.
Riegel B, Jaarsma T, Lee CS, Stromberg A. Integrating Symptoms Into the Middle-Range Theory of Self-Care of Chronic Illness. ANS Adv Nurs Sci. 2019 Jul/Sep;42(3):206-215. doi: 10.1097/ANS.0000000000000237.
Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.
Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Clin Diabetes. 2016 Apr;34(2):70-80. doi: 10.2337/diaclin.34.2.70. No abstract available.
Yuan C, Lai CW, Chan LW, Chow M, Law HK, Ying M. The effect of diabetes self-management education on body weight, glycemic control, and other metabolic markers in patients with type 2 diabetes mellitus. J Diabetes Res. 2014;2014:789761. doi: 10.1155/2014/789761. Epub 2014 Jul 17.
Walker RJ, Smalls BL, Hernandez-Tejada MA, Campbell JA, Egede LE. Effect of diabetes self-efficacy on glycemic control, medication adherence, self-care behaviors, and quality of life in a predominantly low-income, minority population. Ethn Dis. 2014 Summer;24(3):349-55.
Shrivastava SR, Shrivastava PS, Ramasamy J. Role of self-care in management of diabetes mellitus. J Diabetes Metab Disord. 2013 Mar 5;12(1):14. doi: 10.1186/2251-6581-12-14.
Ausili D, Barbaranelli C, Rossi E, Rebora P, Fabrizi D, Coghi C, Luciani M, Vellone E, Di Mauro S, Riegel B. Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory. BMC Endocr Disord. 2017 Oct 16;17(1):66. doi: 10.1186/s12902-017-0218-y.
Ausili D, Rossi E, Rebora P, Luciani M, Tonoli L, Ballerini E, Androni S, Vellone E, Riegel B, Di Mauro S. Socio-demographic and clinical determinants of self-care in adults with type 2 diabetes: a multicentre observational study. Acta Diabetol. 2018 Jul;55(7):691-702. doi: 10.1007/s00592-018-1135-x. Epub 2018 Apr 5.
Sherwani SI, Khan HA, Ekhzaimy A, Masood A, Sakharkar MK. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark Insights. 2016 Jul 3;11:95-104. doi: 10.4137/BMI.S38440. eCollection 2016.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
Savoia E, Fantini MP, Pandolfi PP, Dallolio L, Collina N. Assessing the construct validity of the Italian version of the EQ-5D: preliminary results from a cross-sectional study in North Italy. Health Qual Life Outcomes. 2006 Aug 10;4:47. doi: 10.1186/1477-7525-4-47.
McGuire BE, Morrison TG, Hermanns N, Skovlund S, Eldrup E, Gagliardino J, Kokoszka A, Matthews D, Pibernik-Okanovic M, Rodriguez-Saldana J, de Wit M, Snoek FJ. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010 Jan;53(1):66-9. doi: 10.1007/s00125-009-1559-5. Epub 2009 Oct 20.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SCUDOS
Identifier Type: -
Identifier Source: org_study_id
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