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临床试验/NCT00684086
NCT00684086已完成不适用

English Diabetes Self-Management Program

Stanford University2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2007年4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
350
试验地点
2
主要终点
hemoglobin A1

研究概览

简要总结

We propose a diabetes self-management program evaluation and dissemination project with three components.

  1. A six-month randomized trial to evaluate the effect of a community-based small group Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic control and health care utilization of people with type 2 diabetes.
  2. A long-term (12 month) longitudinal evaluation of the same program.
  3. Two 5 day workshops to train others in California in how to lead and administer the program.

详细描述

  1. Implement and evaluate in a 6-month randomized controlled evaluation an experimental self-management program for patients with type 2 diabetes. Outcomes for evaluating the intervention's impact include health status (health-related quality-of-life and metabolic control) and health care utilization. Mediating outcomes are health behaviors and self-efficacy.
  2. Evaluate the same program in a one year longitudinal study using the same outcomes.
  3. Disseminate the program to others in California by holding two five day workshops during which we will prepare the participants to both offer the program and to train others in their organization to offer the program.

This proposed evaluation will examine the following questions:

Hypothesis 1. People participating in the Diabetes Self-Management Program (SDSMP), when compared six months after baseline to randomized wait-list controls receiving usual care, will demonstrate:

  1. Improvements in health-related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health).

Improvements in metabolic measures of health status (body mass index, hemoglobin A1c, total cholesterol/HDL ratio and blood pressure). 2. Changes in utilization of health services, specifically, increases in outpatient visits to physicians and nurses, increases in the percentage of subjects having received an eye examination in the past year, increases in the number of times a health professional has examined subject's feet, and decreases in emergency room visits, hospitalizations, and hospital days. 3. Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet). 4. Increases in perceived self-efficacy to manage diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • Individuals with prior diagnosis of type 2 Diabetes.
  • Able to speak and comprehend English.
  • Able to give and complete consent forms.
  • Able to complete baseline questionnaire and 2-3 follow-up questionnaires either in writing or by telephone.
  • Able to attend respective community meetings or allow study staff to collect the following metabolic test measures: provide 3 drops of blood for Hemoglobin A1c and cholesterol HDL test (administered by subject), blood pressure measure, height and weight measures.
  • Able to attend the Peer-Led Community-Based Diabetes Self-Management Program workshops offered once a week for six weeks at a community site near subjects residence.

排除标准

  • Individuals not diagnosed with type 2 diabetes.
  • Individuals diagnosed with type 1 diabetes.
  • Pregnant women, including those diagnosed with gestational diabetes.
  • Individuals who have been in active treatment for cancer in the past yar.
  • Individuals not able to speak or comprehend English.
  • Individuals who are currently or have previously participated in a similar program or study.
  • Individuals that are not able to give consent or complete consent forms, and other study related forms such as questionnaires.
  • Individuals who are not able and willing to provide metabolic test data.
  • Individuals not able to attend the 6-week community classes in the target counties in California.

结局指标

主要结局

hemoglobin A1

symptoms of hypoglycemia

symptoms of hyperglycemia

self-monitoring of blood glucose

self-efficacy to manage diabetes

次要结局

  • fatigue
  • physical discomfort
  • activity limitations
  • health distress
  • self-rated health
  • aerobic exercise
  • communication with physicians

研究者

申办方类型
Other

研究点 (2)

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