Type 2 Diabetes
Conditions
Keywords
Self-care, Chronic diseases, Type 2 diabetes, Self-management
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.
Interventions
None listed
Sponsors
IRCCS Policlinico S. Donato
University of Milano Bicocca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 [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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Creatinine [2] | Creatinine blood level will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | Blood concentration of Creatinine measured in mg/dL. |
| Creatinine [3] | Creatinine blood level will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | Blood concentration of Creatinine measured in mg/dL. |
| Estimated Glomerular Filtration Rate (GFR) [1] | GFR will be collected from medical records at the following time point: T0 - Baseline. | GFR estimation measured in mL/min/1.73m² from age, gender, and blood creatinine \[1\] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula. |
| Estimated Glomerular Filtration Rate (GFR) [2] | GFR will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | GFR estimation measured in mL/min/1.73m² from age, gender, and blood creatinine \[2\] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula. |
| Estimated Glomerular Filtration Rate (GFR) [3] | GFR will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | GFR estimation measured in mL/min/1.73m² from age, gender, and blood creatinine \[3\] using the Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 formula. |
| Liver profile [1] | The liver profile will be assessed at the following time point: T0 - Baseline. | Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U/L. |
| Liver profile [2] | The liver profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U/L. |
| Liver profile [3] | The liver profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | Alanine transaminase (ALT), Aspartate transaminase (AST), and Gamma-glutamyltransferase (GGT) blood level measured in U/L. |
| Height | The height will be measured at following time point: T0 - Baseline. | The height measured in meters. |
| Weight [1] | The weight will be measured at the following time point: T0 - Baseline. | The weight detected on the scale during the visit and measured in kg. |
| Weight [2] | The weight will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | The weight detected on the scale during the visit and measured in kg. |
| Weight [3] | The weight will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | The weight detected on the scale during the visit and measured in kg. |
| Abdominal circumference [1] | Abdominal circumference will be measured at the following time point: T0 - Baseline | Abdominal circumference measurement in cm. |
| Abdominal circumference [2] | Abdominal circumference will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | Abdominal circumference measurement in cm. |
| Blood pressure [1] | The blood pressure will be measured at the following time point: T0 - Baseline. | The systolic and diastolic blood pressure measured di mmHg. |
| Blood pressure [2] | The blood pressure will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | The systolic and diastolic blood pressure measured di mmHg. |
| Blood pressure [3] | The blood pressure will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | The systolic and diastolic blood pressure measured di mmHg. |
| Pulse rate [1] | The pulse rate will be measured at the following time point: T0 - Baseline. | The pulse rate measured in beats per minute (bpm). |
| Pulse rate [2] | The pulse rate will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | The pulse rate measured in beats per minute (bpm). |
| Pulse rate [3] | The pulse rate will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | The pulse rate measured in beats per minute (bpm). |
| Short Form 12 (SF-12) [1] | The SF-12 will be administered at the following time point: T0 - Baseline. | 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. |
| Short Form 12 (SF-12) [2] | The SF-12 will be administered by telephone at the following time point: T1 - Month 12 ± 28 days. | 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. |
| Short Form 12 (SF-12) [3] | The SF-12 will be administered by telephone at the following time point: T2 - Month 24 ± 28 days. | 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. |
| EuroQoL - 5 Dimensions - 3 Levels (EQ-5D-3L) [1] | The EQ-5D-3L will be administered at the following time points: T0 - Baseline. | 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/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients |
| Body Mass Index (BMI) [1] | The BMI will be estimated at the following time point: T0 - Baseline. | The BMI measured in kg/m² from height and weight \[1\]. |
| 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. | 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/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients |
| EQ-5D-3L [4] | The EQ-5D-3L will be administered by telephone at the following time point: T1.5 - Month 18 ± 28 days. | 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/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients |
| EQ-5D-3L [5] | The EQ-5D-3L will be administered at the following time point: T2 - Month 24 ± 28 days. | 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/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients |
| Problem Areas in Diabetes Questionnaire Short Form (PAID-5) [1] | The PAID-5 will be administered at the following time point: T0 - Baseline. | 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. |
| 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. | 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. |
| 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. | 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. |
| Pittsburgh Sleep Quality Index (PSQI) [1] | The PSQI will be administered at the following time point: T0 - Baseline. | 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. |
| Pittsburgh Sleep Quality Index (PSQI) [2] | The PSQI will be administered by telephone at the following time point: T1 - Month 12 ± 28 days. | 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. |
| Pittsburgh Sleep Quality Index (PSQI) [3] | The PSQI will be administered by telephone at the following time point: T2 - Month 24 ± 28 days. | 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. |
| Events [1] | Events will be assessed at the following time point: T0 - Baseline. | 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 [2] | Events will be assessed by telephone and collected from medical records at the following time point: T1 - Month 12 ± 28 days. | 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 [3] | Events will be assessed by telephone and collected from medical records at the following time point: T2 - Month 24 ± 28 days. | Any referral or unplanned diabetes visit, request for home care assistance, hospitalisation, access to emergency care, death, received diabetes education in the last year. |
| 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. | 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/discomfort, and anxiety/depression. A Visual Analogue Scale is included in order to assess a general health status level as perceived by patients |
| Body Mass Index (BMI) [2] | The BMI will be estimated at the following time point: T1 - Month 12 ± 28 days. | The BMI measured in kg/m² from height and weight \[2\]. |
| Body Mass Index (BMI) [3] | The BMI will be estimated at the following time point: T2 - Month 24 ± 28 days. | The BMI measured in kg/m² from height and weight \[3\]. |
| Abdominal circumference [3] | Abdominal circumference will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | Abdominal circumference measurement in cm. |
| Lipidic profile [1] | The lipidic profile will be collected from medical records at the following time point: T0 - Baseline. | Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL. |
| Lipidic profile [2] | The lipidic profile will be collected from medical records at the following time point: T1 - Month 12 ± 28 days. | Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL. |
| Lipidic profile [3] | The lipidic profile will be collected from medical records at the following time point: T2 - Month 24 ± 28 days. | Blood concentration of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides measured in mg/dL. |
| Creatinine [1] | Creatinine blood level will be collected from medical records at the following time point: T0 - Baseline. | Blood concentration of Creatinine measured in mg/dL. |
Countries
Italy
Contacts
Primary ContactDavide LL Ausili
Backup ContactMichela Luciani
Outcome results
None listed