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临床试验/NCT04245267
NCT04245267Unknown不适用

Effect of Multicomponent Integrated Care Intervention on the Metabolic Control and Quality of Life in Patients With Type 2 Diabetes: the Mexico City DIAbetes EMPowerment and Improvement of Care Program

Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2017年1月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
2
主要终点
Glycemic control after the program

研究概览

简要总结

Type 2 diabetes is one of the leading causes of morbidity and mortality rate in Mexico. Although important advances in treatment strategies have been developed in type 2 diabetes mellitus, large gaps exist in achieving quality of care. Few studies have determined the effect of multicomponent interventions in low and middle income countries. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.

详细描述

Background: Diabetes mellitus is a chronic metabolic disease with disabling, deadly, and costly consequences for individuals, families, and national health care systems. Proper diabetes management in people living with type 2 diabetes mellitus focuses on reducing the risks for macrovascular and microvascular complications through controlling blood pressure, lipid levels, and blood glucose levels, and avoiding tobacco. Although important advances in pharmacological and non-pharmacological strategies have been developed, large gaps exist in achieving care goals, particularly in real-world practice and low- and middle- income countries. Barriers to care in T2DM patients may include lack of medical care, poverty, long distances or lack of time to get medical attention, lack of confidence, and inadequate social support, among others. Achievement of diabetes care goals: normal glycated hemoglobin, blood pressure, and LDL cholesterol is associated with better health outcomes, including lower risks of complicating events and death. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through a 6-months intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, , and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.

Hypothesis: Participation in the Diabetes Empowerment and Improvement of Care strategy allows reaching diabetes care goals.

General objective: To quantify diabetes care goals achievement at the end of the intervention and one year after finishing the comprehensive care program designed to propitiate diabetes empowerment at Clínica Especializada en el Manejo de la Diabetes of the Mexico City Government.

Specific objectives: To measure the program impact through the following variables: glycated hemoglobin, blood lipids, arterial pressure, self-care activities, diabetes knowledge, health related quality of life, incidence of complications and use of hospital services.

Goals: To improve diabetes care through this multicomponent intervention in order to prevent complications and and enhance quality of life in people with diabetes, but also to expand the care model to primary care health units in Mexico City.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or Women
  • Older than 18 years old, younger than 70 years old
  • Having diagnosis of type 2 diabetes
  • Acceptance for participation in the program by signing informed consent sheet

排除标准

  • Any other type of diabetes, such as Type 1 diabetes, LADA type Diabetes, gestational diabetes, or any other type of diabetes related to genetic syndromes
  • advanced diabetes complications such as ischemic heart disease, NYHA III-IV heart failure, KDOQI renal failure ≥4, cerebral vascular disease with functional sequelae
  • those who have comorbidities that limit their life expectancy such as malignant tumors in advanced stages
  • Dependence of illicit drugs
  • Conditions that require short-term surgical treatment.
  • Advanced cognitive deficit or serious psychiatric disorders that hinder treatment adherence.

结局指标

主要结局

Glycemic control after the program

时间窗: 5 months

HbA1c (%): HbA1c will be compared from the first visit with the last visit (5 months later)

次要结局

  • Glycemic control after 1 year(1 year)
  • Lipid control(1 year)
  • Weight change(1 year)
  • Blood pressure(1 year)
  • Summary of Self-care Activities (0-7, higher score means better self-care)(1 year)
  • Health-related Quality of Life perception assessed by EQ-5D Visual Analogue Scale questionnaire (0-100, higher score means better Quality of life perception)(1 year)
  • Health-related Quality of Life perception assessed by EQ-5D Visual Analogue Scale questionnaire (0-100, higuer score means better Quality of life perception)(5 months)
  • Health-related Quality of Life perception assessed by EQ-5D Indexed score (0-1, higher score means better Quality of life perception)(1 year)

研究者

发起方
Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico
申办方类型
Network
责任方
Sponsor

研究点 (2)

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