Self-care Behaviors of Type 2 Diabetes Mellitus Patients

Recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT07042399
• Lead Sponsor: University of Milano Bicocca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study Start: 2024-03-01
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-care in diabetes [1]	The SCODI will be administered at the following time point: T0 - Baseline.	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.
Self-care in diabetes [2]	The SCODI will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days	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.
Self-care in diabetes [3]	The SCODI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.	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.
Self-care in diabetes [4]	The SCODI will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.	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.
Self-care in diabetes [5]	The SCODI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days.	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.

Secondary Outcome Measures

Name	Time	Method
Glycated Hemoglobin (HbA1c) [1]	The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.	Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Glycated Hemoglobin (HbA1c) [2]	The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.	Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Glycated Hemoglobin (HbA1c) [3]	The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.	Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.

Trial Locations

Locations (2)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Monza Brianza, Italy