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临床试验/NCT01098253
NCT01098253已完成不适用

Integrating Depression Services Into Type 2 Diabetes Mellitus Management

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2009年1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
182
试验地点
2
主要终点
Hemoglobin A1C

研究概览

简要总结

The goal of this proposal is to integrate depression services into improving adherence for oral hypoglycemic agents so that a single program can assist patients. The investigators hypothesized that patients in the intervention would demonstrate improved adherence to patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.

详细描述

Many older patients do not take their medications for Type 2 diabetes mellitus (DM) as prescribed by their physician. Depression is common among patients with Type 2 DM and may be the reason why patients do not take their medications as prescribed. A program in which Type 2 DM and depression are treated together in primary care would improve the health of older patients with both Type 2 diabetes and depression and would be practical in real world practices with competing demands for limited resources. There is an urgent need for research that can bring potentially life-extending strategies to older patients with both diabetes and depression. People can better control their Type 2 DM if they treat their depression and the same strategies can be used to help patients take their medications for both conditions. In this program patients were involved in identifying problems with taking their medicines and working on solutions. The aims of this program were to improve how patients take their medications for Type 2 DM and depression as well as blood glucose control and symptoms of depression over 3 months. To see whether this program works the investigators compared the results of patients receiving this program to those who do not receive the program. Findings may lead to the development of other programs in which depression and chronic medical conditions are treated together.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

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

排除标准

  • inability to give informed consent
  • significant cognitive impairment at baseline (Mini-Mental State Examination (MMSE) <21)
  • residence in a care facility that provides medications
  • unwillingness or inability to use the Medication Event Monitoring System

结局指标

主要结局

Hemoglobin A1C

时间窗: 3 months

HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services

次要结局

  • Nine Item Patient Health Questionnaire (PHQ-9)(3 months)

研究者

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

Hillary Bogner

MD MSCE/ Assistant Professor

University of Pennsylvania

研究点 (2)

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