Self-care Behaviors of Type 2 Diabetes Mellitus Patients
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of type 2 diabetes;
Age over 18 years old;
Adequate comprehension of the Italian language;
Signed and dated informed consent.
Disqualifiers
Presence of documented psychiatric or neurodegenerative disease;
Pregnancy;
Any condition that, by the investigators' judgment, may limit adherence to study procedures
Trial population
The sample will be enrolled among diabetic patients who access hospital diabetes outpatient clinics in Lombardy (a region in the North of Italy)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
The SCODI will be administered at the following time point: T0 - Baseline.2
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.
Time frame
The SCODI will be administered by telephone at the following time point: T0.5 - Month 6 ± 28 days3
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.
Time frame
The SCODI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days.4
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.
Time frame
The SCODI will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days.Secondary outcomes
1
Glycated Hemoglobin (HbA1c) [1]
Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Time frame
The HbA1c blood level will be collected from medical records at the following time point: T0 - Baseline.2
Glycated Hemoglobin (HbA1c) [2]
Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Time frame
The HbA1c blood level will be collected from medical records at the following time point: T1 - Month 12± 28 days.3
Glycated Hemoglobin (HbA1c) [3]
Blood glycated hemoglobin measured in both mmol/mol and % was used as an index of patients' glycemic control.
Time frame
The HbA1c blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.Other outcomes
1
Lipidic profile [1]
Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL.
Time frame
The lipidic profile will be collected from medical records at the following time point: T0 - Baseline.2
Lipidic profile [2]
Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL.
Time frame
The lipidic profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days.3
Lipidic profile [3]
Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL.
Time frame
The lipidic profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days.4
Creatinine [1]
Blood concentration of Creatinine measured in mg/dL.
Time frame
Creatinine blood level will be collected from medical records at the following time point: T0 - Baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Milano Bicocca
Lead sponsor
IRCCS Policlinico S. Donato
Collaborator
Source ClinicalTrials.gov