Evaluation of a Health Education Program for Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in the Summary of Diabetes Self-Care Activities (SDSCA)
研究概览
简要总结
The goal of this, Retrospective and Prospective Low- Interventional study, is to implement health education interventions to promote self-care and reduce disease complications in DM Type 2 patients at higher risk of development/progression of Diabetic Retinopathy. ]. The main question it aims to answer are:
- To evaluate the impact of a health education intervention on mental health, self-care behaviors, and disease knowledge in patients with Diabetes Mellitus Type 2 with high risk of development/progression of Diabetic Retinopathy.
- To evaluate the impact of a health education intervention on the metabolic control of patients with Diabetes Mellitus Type 2 with high risk of development/progression of Diabetic Retinopathy.
Patients will have to (V1 and V4):
- answer three questionnaires, (Summary of Diabetes Self-Care Activities - SDSCA, QCD- Diabetes Knowledge Questionnaire and Depression Anxiety and Stress Scale" (DASS-21).
- measurement of weight and height, to calculate BMI.
- collection of glycated hemoglobin analysis (if they have been done in the last 3 months).
详细描述
Diabetic retinopathy (DR) is the most frequent complication of Diabetes mellitus and the main cause of legal blindness in working populations in industrialized countries.
A diagnosis of diabetes has important implications for individuals, not only for their health, but also because of the stigma that a diagnosis can bring, i.e., it can affect employment, quality of life, mental health, social opportunities, and other cultural aspects. These changes in the lives of diabetics can lead to stress. It is known that diabetes has a social and family connotation that leads to depression and anxiety appearing in parallel, which can influence the self-management that people must do in their daily lives. It is necessary to incorporate and integrate mental health care into all diabetic care.
Individuals with diabetes have difficulties: diagnosis, adherence to treatment, fear of complications and hypoglycemia, which can result in suffering, thus making self-management difficult.
In diabetic patients, the prevalence of symptoms of depression and anxiety is about two to four times higher than in the general population. Metabolic dysregulation influences brain function and disturbances in glucose regulation may be associated with depression. These emotions that arise can be disabling and very strong, leading the individual to often acquire behaviors that do not help in fighting the disease. There may be changes in eating behavior, or alcoholic beverages that are not favorable to glycemic control, that is, glycaemia rises proportionally to the most negative events in life, thus, stress leads to an increase in corticosteroids and consequently increases glycaemia. It is known that physical activity can reduce disease rates, namely diabetes, hypertension, obesity, among others. There are studies that show that physical activity is beneficial, whatever its intensity. It reduces the admission of chronically ill patients to hospitals, reduces pain and increases mental health and quality of life. With the development of physical activity programs applied to chronically ill patients, they are beneficial to promote the management of their disease, physical and mental health, and reduce the appearance of other comorbidities. In Diabetes Mellitus, the causes are complex, and its complications can be prevented with a healthy diet, normal blood glucose, adequate weight, and physical activity. For health professionals, who deal with these chronically ill patients, they have a huge challenge, since these people present risk behaviors (unhealthy eating and/or sedentary lifestyle). To assess the disease, there is glycosylated hemoglobin (HbA1c), which reflects the average blood glucose. It is used as a risk parameter and considered the gold standard for assessing glycemic control. The American Diabetes Association (ADA) sets HbA1c < 7% as the threshold of good control for most people with diabetes. To improve glycemic control, nutritional monitoring is important. Nutrition education is considered a preventive and treatment strategy to provide diabetic people with the necessary tools to face the change in lifestyle and achieve self-management of the disease. For this, it is necessary to increase knowledge, acquisition of skills, as well as promote the modification of attitudes and behaviors. It is important to increase people's active participation in the control and treatment of their disease.
Diabetics should participate in self-care education actions with the body, to improve the knowledge, skills, and abilities necessary for the self-care of this pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 DM participating in STAR (CEC/008/16) and EYEMARKER (CEC/009/17)
- •Higher risk patients through the RetinaRisk ® app ≥ 3%
- •Age ≥50 years
- •Body mass index (IMC) ≥ 25;
- •Glycated hemoglobin (HbA1C): ≥6.5%; (7)
- •Arterial hypertension (HTA): ≥ 139-89 (8)
- •Presence of mild to moderate NPDR with presence of visible retina lesions (microaneurysms, hemorrhages, hard exudates and soft exudates)
- •Subjects capable of understanding the information about the study and giving their informed consent to enter the study.
- •Subjects willing and able to comply with the study.
排除标准
- •Type 1 DM
- •Moderately Severe NPDR;
- •Presence of DME or PDR
- •Other retinal vascular diseases than DR
结局指标
主要结局
Change in the Summary of Diabetes Self-Care Activities (SDSCA)
时间窗: 3 months
total and subscales scores (general diet; specific diet; exercise; blood-glucose testing; foot-care; smoking) three months after the health education intervention training sessions. The scale used is number of days (from 0 to 7)
Change in the Diabetes Knowledge Questionnaire (DKQ - Portuguese version)
时间窗: 3 months
Subscales scores (treatment, control and complications; causes; duration) three months after the health education intervention training sessions. This consists of 20 items distributed by three dimensions (Treatment, control and complications, Causes and Duration).The minimum and maximum values is 0-100, the 0 is minimum and 100 is maximum
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21)
时间窗: 3 months
total and subscales scores (depression; anxiety; stress) three months after the health education intervention training sessions. The scale score,(lower scores mean a better result), (the minimum and maximum values): 0 - Nothing applied to me 1. \- It applied to me a few times 2. \- It has applied to me many times 3. \- It applied to me most of the time
次要结局
- Measure the change in BMI(3 months)
- Measure the change in the blood HbA1C level(3 months)
