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临床试验/NCT01106885
NCT01106885已完成不适用

Effective Care Management of Depressed Diabetes Patients

University of Michigan6 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2005年5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
339
试验地点
6
主要终点
Participant HbA1c levels

研究概览

简要总结

Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.

详细描述

Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized to: (1) brief education about depression, diabetes self-care, and physical activity; or (2) telephone care management including antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify efficacious antidepressants and promote adherence. The CBT module addresses symptoms, exercise, and communication skills.

Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to measure their health status, self-care, provider-patient communication, and resource use. At 4 months, they will complete a mailed questionnaire to capture short-term changes in depressive symptoms, walking, patient-provider communication, medication adherence, and quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and cholesterol will be measured via a fingerstick blood test. We also will measure blood pressure, height, and weight. With patients' 4-month mailed surveys, they will complete fingerstick A1c tests and return the results via mail. The blood tests are identical to those diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record their walk distances for one week and return the results via mail. Electronic data: Utilization and billing databases will be used to identify health service utilization (ER visits, outpatient care, hospitalizations) occurring during patients' participation and the prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will complete a brief survey about the patient's communication style. All patients will provide written consent administered prior to their face-to-face screening and baseline interviews. Physician 12-month surveys about patients' communication style will be anonymous.

研究设计

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

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Participant HbA1c levels

时间窗: one year

Participant cardiovascular risk index

时间窗: one year

次要结局

  • Proximal intervention targets(one year)
  • Other self-care behaviors(one year)
  • Health-related quality of life(one year)
  • Treatment satisfaction(one year)
  • Resource use(one year)

研究者

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

John Piette

VA Senior Research Career Scientist and Professor of Internal Medicine

University of Michigan

研究点 (6)

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