Self-care Behaviours of Type 2 Diabetes Mellitus Patients: a Multicenter Prospective Observational Study With 2 Years Follow-up (SCUDOS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Self-care in diabetes [1]
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes;
- •Age over 18 years old;
- •Adequate comprehension of the Italian language;
- •Signed and dated informed consent.
排除标准
- •Presence of documented psychiatric or neurodegenerative disease;
- •Pregnancy;
- •Any condition that, by the investigators' judgment, may limit adherence to study procedures
结局指标
主要结局
Self-care in diabetes [1]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 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.
次要结局
- 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.)
研究者
Davide Ausili
Associate Professor of Nursing Science
University of Milano Bicocca