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临床试验/NCT02836808
NCT02836808招募中不适用

Validation of an Integrated Attention Model for Patients With Type 2 Diabetes

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2013年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
2
主要终点
Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes

研究概览

简要总结

Abstract: Empowerment interventions for chronic diseases are an evolving process. No agreement exists regarding the necessary components and methodologies to be applied. Systematic reviews have assessed the effect of self-management interventions. Improvements in illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the long term, no major changes have been achieved in weight, physical activity, smoking status, and depression scores.

There is a need for additional studies. The Center for Comprehensive Care of Patients with Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment techniques (using simple low-cost interactive tools) over a short period of time followed by at-distance support using internet or cell phone technology. The target population consists of patients with type 2 diabetes, free of chronic complications who are non-smokers. The intervention is composed of four monthly visits followed by a continuous at-distance support system. At each visit, patients stay for six hours in the center. Information is presented in group sessions. Empowerment techniques are applied during individual exchanges with the team or during facilitated group sessions. In summary, empowerment programs are an unmet need in many healthcare services.

详细描述

  1. Background: There are major deficiencies in the attention quality provided to people with diabetes in Mexico. The percentage of compliance of therapeutic objectives is noticeably lower than the one informed in developed countries. It is required to have structured management strategies, adapted to traits of our population, which allow improving attention quality in the medium term. The National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) developed an integrated management program by using the best evidence available. The target population is people with type 2 diabetes, with less than 5 years with the diagnosis, and is free from chronic complications. Selection criteria allow the intervention benefit to diminish incidence of chronic complications.
  2. Hypothesis: "The management strategy applied at the Center of Comprehensive Care for the Patient with Diabetes (CAIPaDi) allows achieving the international treatment standards (proposed by NCQA) in a two-year period".
  3. General and Specific objectives:

General objective: To quantify the results one year after starting the integrated management program oriented to self-care activities applied at CAIPaDi.

Specific objectives:

  • To measure the program impact (after 4 months, one and two years) based on the following variables: self-care (measured with standardized questionnaires), efficacy parameters (HbA1c, fasting glycemia, blood lipids, arterial pressure and use of anti-platelet aggregates), execution parameters (compliance of evaluations and preventive measures such as the search for microalbuminuria, ophthalmologic check, influenza vaccination, among others), incidence of micro- and macrovascular complications of diabetes, hospitalizations, use of emergency service or unforeseen expenses related to diabetes.
  • To compare the efficacy and execution parameters of the cases attended at the center, with patients with similar characteristics attended at the "Internal Medicine" service of the INCMNSZ.
  • To carry out a study of the social-economic impact of the intervention.
  1. Goals: It is intended to validate an intervention that provides integrated attention to people with diabetes, in order to generate in the patient and his/her family, the competencies required for self-care in the long term and the prevention of chronic characteristics. Intervention is low-cost. This characteristic, along with the intervention systematization will allow the model to be exportable to the first-contact units.
  2. Scientific Methodology: CAIPaDi has the mission of improving quality of life of patients with diabetes by means of an intervention adapted to the needs of patients, applying step-by-step action programs".

Intervention consists of four monthly visits, each one being 6 hours long. The visits have individual and group sessions. The nine specialists in the multidisciplinary team are endocrinologists, diabetes educator, nutritionists, psychologist, dentists, psychiatrist, specialist in physical activity, ophthalmologist and foot care. Some of the functions may be fulfilled by the same health professional, previously trained.

At each session, standardized actions are applied, which are assessed with preset indicators. At the initial and at yearly visits the following laboratory tests are taken: glycated hemoglobin, blood chemistry, lipid profile, liver function tests, albumin-creatinine index in an isolated urine sample, and 12-deviation electrocardiogram. At the yearly visits the patients receive reinforcement and treatment modifications as needed.

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

  • being over 18 and under 70 years old
  • having diagnosis of type 2 diabetes in the five previous years,
  • having family support
  • free of disabling diabetes complications

排除标准

  • advanced complications of diabetes, such as ischemic heart disease, heart failure NYHA III-IV, KDOQI ≥3 renal failure, amputations, cerebral vascular disease, gastroparesis and muscular atrophy .
  • type 1 diabetes mellitus, gestational diabetes or some variant of diabetes related to genetic syndromes, hyperlabile diabetes
  • co-morbidities that limit their life expectancy such as malignant tumors
  • advanced cognitive impairment or serious psychiatric disorders
  • smoking, alcoholism or illegal drug dependence
  • conditions that require surgical treatment in the short run or which prevent moderated activity.

研究组 & 干预措施

Control

No Intervention

Patients attended with the standard model of care for diabetes, as out-patients in the Internal Medicine area

CAIPaDi

Experimental

Patients attended in the Center of Comprehensive Care for the Patient with Diabetes, where they receive attention from 9 specialists in 1 day

干预措施: CAIPaDi (Behavioral)

结局指标

主要结局

Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes

时间窗: 3 months

HbA1c is measured in percentage (%). HbA1c will be compared from the first visit with the fourth visit.

次要结局

  • Diabetes control after 1 year in a structured multidisciplinary program for patients with diabetes(1 year)
  • Self-care by SDSCA questionnaire after 4 visits in a structured multidisciplinary program for patients with diabetes(3 months)
  • Diabetic complications are eye, renal and foot evaluations after 4 visits in a structured multidisciplinary program for patients with diabetes(3 months)
  • Self-care by SDSCA questionnaire after 1 year in a structured multidisciplinary program for patients with diabetes(1 year)
  • Self-care by SDSCA questionnaire after 2 years in a structured multidisciplinary program for patients with diabetes(2 years)
  • Renal function after 4 visits in a structured multidisciplinary program for patients with diabetes(3 months)
  • Diabetic complications are eye, renal and foot evaluations after 1 year in a structured multidisciplinary program for patients with diabetes(1 year)
  • Quality of life after 2 years in a structured multidisciplinary program for patients with diabetes(2 years)
  • Renal function after 1 year in a structured multidisciplinary program for patients with diabetes(1 year)
  • Quality of life after 1 year in a structured multidisciplinary program for patients with diabetes(1 year)
  • Diabetes control after 2 years in a structured multidisciplinary program for patients with diabetes(2 years)
  • Metabolic parameters are lipid profile after 2 years in a structured multidisciplinary program for patients with diabetes(2 years)
  • Metabolic parameters are lipid profile after 4 visits in a structured multidisciplinary program for patients with diabetes(3 months)
  • Quality of life after 4 visits in a structured multidisciplinary program for patients with diabetes(3 months)
  • Metabolic parameters are lipid profile after 1 year in a structured multidisciplinary program for patients with diabetes(1 year)
  • Renal function after 2 years in a structured multidisciplinary program for patients with diabetes(2 years)
  • Diabetic complications are eye, renal and foot after 2 years in a structured multidisciplinary program for patients with diabetes(2 years)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Sponsor

研究点 (2)

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