Impact of Self-care Education Program "Active Patient" in Metabolic Control, Cardiovascular Risk and Quality of Life in Patients With Type 2 Diabetes in Primary Care in the Basque Country: Randomized Clinical Trial of 2 Years of Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 594
- 试验地点
- 2
- 主要终点
- Change in Glycated hemoglobin
研究概览
简要总结
Main objective:To evaluate the effectiveness of the "Diabetes Self-Management Programme" (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and self-efficacy in adult patients with type 2 diabetes, compared with current standard care of patients with type 2 diabetes, in the context of Osakidetza's Primary Care network.
Secondary objectives:
- To evaluate the impact of the implementation of DSMP in the use of health services.
- To assess the impact of DSMP in the cost of treatment of the involved population.
- To evaluate the improvement in physical activity and diet patterns among the participants.
- To describe the feasibility of implementing the DSMP in the Basque Country's primary health care system Methodology: Randomized clinical trial in which patients diagnosed with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of the Basque country, who agree to participate in the study, will be randomly assigned to two groups: the intervention group (the DSMP programme) and the control group. The intervention will be performed by trained patients with type 2 diabetes and health professionals and it will consist in 6 group sessions of two and a half hours each, on a weekly basis with a overall duration of 6 weeks. The session content includes techniques for dealing with problems, promotion of exercise, nutrition concepts, proper use of medication, effective communication and basic knowledge about diabetes and its complications. The sessions are supported with educational material. The main outcome is the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are reduction of cardiovascular risk, increase of quality of life and self-efficacy. The results will be analyzed at 6, 12 and 24 months after the intervention.
Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on the program DSMP conducted by previously trained lay persons and health professionals, improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to regular health education. On the other hand, it is expected to see improvements in the quality of life for these patients. The intervention may reduce the weight and cardiovascular risk due to changes in the physical activity and diet patterns, getting to a more appropriate use of health services and medication. It is expected that changes in the variables occur 6 months after the intervention and remain over the time
详细描述
Background
The management of chronic diseases (CD) is a challenge for health services. The health system must provide a more efficient and coordinated care for people with CD aimed at reducing their decompensation and improving the quality of life for both the patient and his/her family. In this task, primary care (PC) plays a key role (Bengoa, 2008).
The better living conditions and the current development of health care have produced a demographic shift in population, resulting in increased life expectancy and therefore the prevalence of CD. In the Basque Country (BC), the population over 65 has increased in recent years by 25% (EUSTAT 2005). According to the BC Health Survey of 2007, prevalence of CD is increasing in our community as 83.5% of men and 86.1% of women over 65 have a chronic disease (Arcelay, 2009). In the health system, 80% of primary care consultations are caused by CD, representing 60% of hospital admissions and 70% of health spending (Bengoa, 2008).
The incidence of diabetes mellitus type 2 (DM2) in the BC has also increased in recent years. Currently, it is estimated that the prevalence of DM2 may be up to 12% in people over 30 years. An evaluation of the diabetic population coverage in primary care records estimates that up to 4% of the diabetic population remains undiagnosed.
Cardiovascular morbidity and mortality in people with DM2 is higher than in the general population. The mortality rate for diabetes is between 13 and 30 deaths per 100,000 people per year. 75% of patients with diabetes die due to cardiovascular disease, especially coronary heart disease. Between 6.3% and 7.4% of the spending in our health care system is deemed to be caused by diabetes. Self-promotion has a paramount importance in diabetes care (diabetes Strategy in the National Health System, 2007). It is estimated that 42% of diabetics in our community are obese, 79.6% are hypertensive and 22% have diabetic macroangiopathy (Arteagoitia, 2003).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years from four primary regions of the Basque Country: Araba, Bidasoa, Ezkerraldea- Enkarterri, Ekialde, with type 2 diabetes who have agreed to participate in the "Active Patient".
排除标准
- •Adults over 80 years or patients with mental disorder that distorts reality (schizophrenia, bipolar disorder, Alzheimer's disease, psychosis, dementia) or morbidity which can interfere with the course, like chronic patients at home.
研究组 & 干预措施
Standardized care
The control group will receive usual care for secondary prevention of type 2 diabetes according to usual care in Osakidetza's primary care.
Self-management education programme
Attendees will receive the Diabetes Self-Management Programme in spanish version (Manejo personal de la diabetes).
干预措施: Diabetes Self-Management Program (Behavioral)
结局指标
主要结局
Change in Glycated hemoglobin
时间窗: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention
The investigators are going to measure the diference between basal Glycated Hemoglobin and 6,12 and 24 months Glycated Hemoglobin.
次要结局
- Change in Cardiovascular risk(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in quality of life(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in self efficacy(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in health services utilization(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Introduction or removal of hypoglycaemic drugs(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Introduction or removal of antiplatelet drugs(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Introduction or removal of antihypertensive drugs(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Introduction or removal of lipid drugs(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in the percentage of patients with HbA1c less than 7%(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in BMI(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in blood pressure(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in percentage of patients with SBP <140 and DBP <80(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in the value of total cholesterol(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in the value of HDL-cholesterol(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in physical activity(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
- Change in the diet composition(Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
研究者
Estibaliz Gamboa Moreno
Diploma of Nursing
Osakidetza