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临床试验/NCT02178176
NCT02178176已完成不适用

Participatory Design of Patient-centered Depression and Diabetes Care

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Depression: nine-item Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •18 years and older
  • •a current diagnosis of Type 2 DM
  • •current prescription for an oral hypoglycemic agent
  • •able to communicate in English
  • •willing to give informed consent

排除标准

  • •acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately)
  • •significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21)
  • •markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)

研究组 & 干预措施

Education, encouragement, card sort

Experimental

干预措施: Education, encouragement, card sort (Behavioral)

Education, encouragement

Active Comparator

干预措施: Education, encouragement (Behavioral)

结局指标

主要结局

Depression: nine-item Patient Health Questionnaire (PHQ-9)

时间窗: Baseline and 14 weeks

Glycemic control: hemoglobin A1c

时间窗: Baseline and 14 weeks

Adherence to oral hypoglycemic agents: Medication Event Monitoring System

时间窗: Over 14 weeks

次要结局

未报告次要终点

研究者

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

Hillary Bogner

Associate Professor

University of Pennsylvania

研究点 (1)

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