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临床试验/NCT01274715
NCT01274715已完成不适用

Behavioral Health Coaching for Rural Veterans With Diabetes and Depression

Michael E. DeBakey VA Medical Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011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
12
试验地点
2
主要终点
Change in PHQ-9 (Patient Health Questionnaire-9)Scores

研究概览

简要总结

The purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., HA1C) and improvement in reported depressive symptoms.

详细描述

The co-occurence of diabetes and depression is highly prevalent and has dramatic consequences for quality of life and health. Due to the complex interrelation between diabetes and depression, patients often experience both psychological and physiological difficulties. These comorbid problems demand focused interventions that blend physical and emotional health treatments with self-management strategies.Rural-dwelling veterans with diabetes and depression are typically treated in community-based outpatient clinics (CBOCs). Patients with diabetes in rural areas tend to have more problems controlling their blood sugar, blood pressure and cholesterol compared to urban patients; thereby increasing their risk of diabetic complications. Similarly, rural patients with depression have similar barriers to care that increase their risk of poorer health outcomes as well. Using behavioral health coaches (BHCs)to deliver telephone-mediated therapies may enhance the reach of treatments for co-occurring diabetes and depression. The implementation of such treatments requires the development and testing of therapeutic manuals and BHC training protocols to ensure standardization and effectiveness. The BHC intervention has been labeled Health Outcomes through Patient Empowerment (HOPE) and will be offered to eligible patients receiving care through MEDVAMC and its CBOCs. Preliminary data obtained through this pilot grant is to support a larger VA grant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Diagnosis of type 2 diabetes and Primary Care Physician intent to treat
  • Clinically significant symptoms of depression per self-report
  • HA1C average of 7.5 or greater in past 12 months AND no HA1C < 7.0 in past 12 months.

排除标准

  • Factors that render a telephone-based behavioral activation intervention inappropriate
  • Significant cognitive impairment
  • Meet criteria of bipolar, psychotic or substance abuse disorder
  • Serious medical issues; e.g., terminal cancer
  • Reports severe depression or suicidal ideation

结局指标

主要结局

Change in PHQ-9 (Patient Health Questionnaire-9)Scores

时间窗: Baseline, 3 months, and 6 months

The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

Change in Hemoglobin A1C

时间窗: baseline, 3 months, and 6 months

Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.

次要结局

未报告次要终点

研究者

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

Aanand Naik

Assistant Professor of Medicine

Michael E. DeBakey VA Medical Center

研究点 (2)

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