跳至主要内容
临床试验/NCT02053714
NCT02053714已完成不适用

Improving Diabetes Outcomes for Persons With Severe Mental Illness

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年12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
18
试验地点
2
主要终点
Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.

研究概览

简要总结

Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM). Unfortunately, persons with mental illness and T2DM are less likely to receive recommended diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to microvascular and macrovascular complications later in life. Evidence-based diabetes self-management education and support interventions have yet to be adapted for persons with mental illness and there have been no randomized controlled trials (RCTs) to examine their feasibility and efficacy. The purpose of this study is to assess the feasibility of conducting a RCT of a diabetes self-management intervention for persons with severe mental illness and T2DM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes plus severe mental illness -

排除标准

  • 未提供

结局指标

主要结局

Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.

时间窗: Baseline, 6 months

次要结局

  • Changes in HBA1c values from baseline to six months.(Baseline, 6 months)
  • Changes in subscapular skinfold measurement from baseline to 6 months.(Baseline, 6 months)
  • Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy.(Baseline, 6 months)
  • Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.(Baseline, 6 months)
  • Changes in waist circumference from baseline to six months.(Baseline, 6 months)
  • Changes in body mass index from baseline to six months.(Baseline, 6 months)
  • Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.(Baseline, 6 months)
  • Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.(Baseline, 6 months)
  • Changes in triceps circumference from baseline to six months.(Baseline, 6 months)
  • Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy.(Baseline, 6 months)
  • Changes in diastolic and systolic blood pressure from baseline to six months.(Baseline, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验