Self-care Behaviors of Type 2 Diabetes Mellitus Patients

NCT07042399 | Recruiting

• 1 other identifier: SCUDOS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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.

Conditions

Type 2 Diabetes

Keywords

Self-care; Chronic diseases; Type 2 diabetes; Self-management

Outcome Measures

Primary Outcomes (5)

• 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/his 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.

• Self-care in diabetes [2]

  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/his 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 by telephone at the following time point: T0.5 - Month 6 ± 28 days

• Self-care in diabetes [3]

  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/his 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 by telephone at the following time point: T1 - Month 12 ± 28 days.

• Self-care in diabetes [4]

  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/his 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 by telephone at the following time point: T1.5 - Month 18 ± 28 days.

• Self-care in diabetes [5]

  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/his 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 by telephone at the following time point: T2 - Month 24 ± 28 days.

Secondary Outcomes (3)

• Glycated Hemoglobin (HbA1c) [1]

  The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.

• Glycated Hemoglobin (HbA1c) [2]

  The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.

• Glycated Hemoglobin (HbA1c) [3]

  The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

Other Outcomes (45)

• Lipidic profile [1]

  The lipidic profile will be collected from medical records at the following time point: T0 - Baseline.

• Lipidic profile [2]

  The lipidic profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.

• Lipidic profile [3]

  The lipidic profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample will be enrolled among diabetic patients who access hospital diabetes outpatient clinics in Lombardy (a region in the North of Italy)

You may qualify if:

• Diagnosis of type 2 diabetes;
• Age over 18 years old;
• Adequate comprehension of the Italian language;
• Signed and dated informed consent.

You may not qualify if:

• Presence of documented psychiatric or neurodegenerative disease;
• Pregnancy;
• Any condition that, by the investigators' judgment, may limit adherence to study procedures

Sponsors & Collaborators

• University of Milano Bicocca: lead
• IRCCS Policlinico S. Donato: collaborator

Study Sites (2)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza Brianza, 20900, Italy

RECRUITING

Related Publications (15)

• 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.

  PMID: 31630807 BACKGROUND

• 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.

  PMID: 30475237 BACKGROUND

• 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.

  PMID: 22739426 BACKGROUND

• 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.

  PMID: 27092016 BACKGROUND

• 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.

  PMID: 25136645 BACKGROUND

• 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.

  PMID: 25065078 BACKGROUND

• 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.

  PMID: 23497559 BACKGROUND

• 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.

  PMID: 29037177 BACKGROUND

• 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.

  PMID: 29623431 BACKGROUND

• 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.

  PMID: 27398023 BACKGROUND

• 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.

  PMID: 11491192 BACKGROUND

• 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.

  PMID: 16901340 BACKGROUND

• 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.

  PMID: 19841892 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 22526760 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Davide LL Ausili

  Università degli Studi di Milano - Bicocca

  STUDY DIRECTOR

Central Study Contacts

Davide LL Ausili

CONTACT

+39 0264488032; davide.ausili@unimib.it

Michela Luciani

CONTACT

+39 0264488168; michela.luciani@unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing Science

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: June 29, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Support information will be made sharable even before enrollment begins. IPD will be shared at the end of data collection for each time point. At the end of the follow-up, data will remain shareable for 5 years
• Access Criteria: Being a researcher of one of the centers involved in the study

Locations

IT (2)