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临床试验/NCT00481286
NCT00481286已完成不适用

Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients

Baylor College of Medicine0 个研究点目标入组 129 人开始时间: 2007年4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
129
主要终点
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein

研究概览

简要总结

The purpose of this study is to determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes.

详细描述

Among persons aged 55-84 years, over 65% have one to three common medical conditions (e.g., hypertension, diabetes, arthritis, stroke, heart disease, etc.). Fortunately, large randomized clinical trials have demonstrated the effectiveness of treatment and prevention strategies for many chronic conditions (e.g., dietary modification and medications for hypertension, intensive glucose monitoring with diet and medication regimens for diabetes, etc.). Despite the significant findings from numerous clinical trials, most older persons continue to suffer from uncontrolled hypertension, hyperglycemia, and other predictors of poor health outcomes. Non-compliance with clinical guidelines by providers (i.e. clinical inertia) and non-adherence to doctors' recommendations are typically blamed for these unacceptably poor outcomes. For older adults with several conditions, the processes of patient-clinician collaboration are not well understood. Goal-setting behaviors may improve health care by linking desired outcomes (i.e., reduce risk of heart attacks) to the goals of care (i.e., salt restriction for hypertension control). Furthermore, the process of goal-setting may be more effective if patients internalize the importance of a particular goal and prioritize that goal among multiple clinical problems (i.e., hypertension care for patients with diabetes.

Effective methods of implementing collaborative goals and training patients to negotiate shared goals and goal-directed behaviors with their clinicians have been developed for diabetes control. The effectiveness of these methods may be enhanced through the use of clinics that enroll small groups of subjects with rapid follow-up for several weeks. Group clinics have demonstrated improved outcomes for common chronic conditions. Evidence demonstrating the synergistic benefit of efficient group clinics and collaborative goal-setting is limited. However, an approach combining these methodologies may provide an improved method of rapidly controlling multiple chronic conditions and maintaining control of those chronic conditions over a prolonged time period.

To address the gap in the implementation of effective and efficient medical care, we will develop and test a model of collaborative group clinics that empowers older patients to adopt goal-setting behaviors, increases communication with their health care provider, and improves their diabetes-related outcomes. The objectives are to use a collaborative group clinic to: 1) Improve diabetes process of care outcomes over a 3 month time period; 2) Significantly improve the maintenance of diabetes process of care improvements over a 12 month time period; and 3) Significantly improve use of self-management behaviors for diabetes care.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of diabetes and hypertension
  • HgA1C value greater than or equal to 7.5
  • Creatinine value less than or equal to 2.0mg/dl
  • SBP greater than or equal to 140

排除标准

  • Prior diagnoses of dementia using ICD-9 codes validated for a VA population

结局指标

主要结局

Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein

时间窗: 12 months

Change in systolic blood pressure; change in Hemoglobin A1C; change in low

次要结局

  • Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic(12 months)

研究者

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

Aanand Naik

Associate Professor, Medicine-Health Srvcs Research

Baylor College of Medicine

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