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临床试验/NCT00496145
NCT00496145已完成不适用

Spanish Diabetes Self-Management Program

Stanford University2 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2002年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
567
试验地点
2
主要终点
Hemoglobin A1c, Health Distress, Symptoms of Hypoglycemia, Symptoms of Hyperglycemia

研究概览

简要总结

Type II diabetes is a growing health concern for Latinos who not only have a higher incidence of the disease but also suffer great morbidity. At the same time due to poverty, language, low literacy and lack of continuity of care, this population is largely excluded from current diabetes education programs. To assist with this problem we propose to evaluate 1) a community-based, peer-led Spanish Diabetes Self-Management Program that is culturally appropriate and acceptable based on self-efficacy theory, and 2) the effects of long-term, self-tailored educational reinforcement offered by means of automated telephone disease management messages. Should this research be successful it will provide an evidenced based public health diabetes education model for use with Latino populations throughout the United States.

详细描述

Diabetes self-management education is increasingly recognized in best practice guidelines and reimbursement policies as a critical ingredient of appropriate health services, especially for the Latino population. Latinos, in addition to carrying a heavy burden of diabetes and related comorbid conditions, encounter limited access to health care and health education due to economic, language and cultural barriers. The proposed project is a health status and health care utilization outcome study. It is unique in that: 1) it will evaluate a low-cost replicable, community-based, diabetes education model, 2) it will study the long-term effects of a low-cost, easily replicable reinforcement system, ATDM calls, and 3) it targets Spanish-speakers, who are at high risk for type 2 diabetes, for diabetes-related complications, and who are under-served by existing programs.

The background for this study is derived from our long-standing programs of research on chronic disease self-management and automated telephone disease management (ATDM) as well as the research of others. This research has demonstrated that: 1) Self-management programs and ATDM programs can improve health-related quality of life, metabolic control, and health care utilization. 2) The effects of these programs on health-related quality of life and health care utilization are mediated partially by enhancement of perceived self-efficacy to cope with the consequences of chronic disease. 3) Self-management education has a potential for achieving substantial financial savings through decreased use of inpatient and outpatient health care.

Information about the outcomes of health self-management programs for Latinos is more fragmentary. However, analyses of our Spanish language Arthritis Self-Management Program and analysis of a pilot of our Spanish Diabetes Self-Management Program suggest that self-management programs can be extended successfully to Latinos. Work by Piette has demonstrated that 1) monolingual Spanish speakers can and will use automated telephone disease management (ATDM) calls as part of their care, 2) Latinos will use ATDM calls to access health education, and 3) ATDM-supported diabetes care can improve health-related quality of life, metabolic control and self-management behaviors.

BACKGROUND AND SIGNIFICANCE

Six factors contribute to the significance of the proposed research. These include 1) the growing population of Latinos in the United States, 2) the disproportional burden of diabetes in the Latino population, 3) the costs of diabetes care coupled with decreasing access to care for the uninsured and underinsured, 4) the lack of well developed and evaluated diabetes education interventions for Latinos, 5) growing evidence that psychosocial interventions for diabetes can impact both health status and health care costs, and 6) evidence that perceived self-efficacy is an important mediator of changes in health related quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosed with type 2 diabetes
  • Speaks and understands Spanish language
  • Able to attend community based diabetes education workshops

排除标准

  • Undergoing active cancer treatment
  • Diagnosed with insulin dependant diabetes (type 1)
  • Pre or borderline diabetes
  • Prior or concurrent participation in other diabetes self-management program
  • Clinical diagnosis of Alzheimer's Disease
  • Mental health condition preventing group participation or cognitive ability

结局指标

主要结局

Hemoglobin A1c, Health Distress, Symptoms of Hypoglycemia, Symptoms of Hyperglycemia

时间窗: 6 month and 18 month

次要结局

  • Amount of exercise,self-efficacy, communication with physician,fatigue, activity limitation,physician visits(6-month and 18-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate Lorig

Principle Investigator

Stanford University

研究点 (2)

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