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临床试验/NCT01498159
NCT01498159已完成不适用

Health Promoters and Pharmacists in Diabetes Team Management

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2011年12月最近更新:
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
244
试验地点
2
主要终点
Hemoglobin A1c

研究概览

简要总结

This research evaluates a diabetes management intervention designed to improve medication adherence and intensify therapy to reach goals in blood sugar, blood pressure, and cholesterol levels. This study will determine the benefit and cost of adding community health promoters to pharmacist disease management services. If there is benefit, then this approach may help reduce the burden of diabetes and its related complications among minorities with diabetes.

详细描述

Many African-Americans and Latinos with diabetes do not achieve the recommended goals for normal blood sugar, blood pressure, or cholesterol level, placing them at high risk for complications. This study will evaluate the impact of a novel intervention designed to improve lifestyle behaviors and medication adherence, and intensify therapy to reach goals. The first component of the intervention includes a clinic-based pharmacist disease management program. The program includes detailed patient assessments, physician-approved treatment plans, patient education and support services to enhance medication adherence. In addition, this program includes intensification of medication therapy to improve blood sugar, blood pressure, and cholesterol levels to reach recommended goals. The second component of the intervention includes health promoters (HPs), or community-based lay health workers. Health promoters are commonly found in minority communities and provide assistance for individuals overcoming language, cultural, and other barriers to conventional health care services. They may provide autonomy support and solve problems related to medication adherence barriers. Furthermore, health promoters may complement pharmacist activities by improving access to medications, assisting in continuity of care with providers, monitoring response to therapy, and reinforcing educational messages. The proposed study will determine whether the addition of health promoters to clinic based pharmacist service delivery improves care. The study will involve the recruitment of 300 African-American and Latino adults with uncontrolled diabetes through the University of Illinois Medical Center in Chicago and randomization to one of two groups: (1) pharmacist management (Pharm) for 12 months; or (2) pharmacist management with HP support (Pharm+HP) for 12 months. Cross-over will occur at 12 months such that the Pharm group will be intensified by the addition of HP support and HP support will be phased out from the Pharm+HP group to assess maintenance. The specific aims include: (1) To evaluate the effectiveness of Pharm+HP compared with Pharm alone on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels; (2) To evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes by phasing out HP support from the Pharm+HP group after year 1; (3) To evaluate the intensification offered by adding an HP after one year of Pharm alone; and (4) To evaluate the cost and cost-effectiveness of Pharm+HP and Pharm alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Self-identified as Latino/Hispanic or African-American
  • Verbal fluency in English or Spanish
  • Age 21 or above
  • History of type 2 diabetes (> 1 year)
  • Hemoglobin A1c ≥ 8.0% (within 1 year)
  • Receives primary care at UIMC (> 1 year)
  • Taking at least one oral medication for diabetes or hypertension

排除标准

  • Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
  • Lives outside Chicago communities of recruitment (3+ months/year)
  • Household member already participating in same study
  • Plans to move from the Chicago area within the next year
  • Pregnant or trying to get pregnancy

研究组 & 干预措施

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Pharmacist communication with primary care physicians (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Pharmacist documentation in electronic medical record (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Health promoter-patient encounters in-person or by phone (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Health promoter medication and lifestyle support (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Health promoter communication with pharmacists (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Pharmacist disease/medication management (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Pharmacist-patient encounters (Behavioral)

Pharmacist + Health Promoter

Experimental

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

干预措施: Pharmacist medication intensification and adherence support (Behavioral)

Pharmacist

Active Comparator

Participants will receive support from pharmacist.

干预措施: Pharmacist communication with primary care physicians (Behavioral)

Pharmacist

Active Comparator

Participants will receive support from pharmacist.

干预措施: Pharmacist documentation in electronic medical record (Behavioral)

Pharmacist

Active Comparator

Participants will receive support from pharmacist.

干预措施: Pharmacist disease/medication management (Behavioral)

Pharmacist

Active Comparator

Participants will receive support from pharmacist.

干预措施: Pharmacist-patient encounters (Behavioral)

Pharmacist

Active Comparator

Participants will receive support from pharmacist.

干预措施: Pharmacist medication intensification and adherence support (Behavioral)

结局指标

主要结局

Hemoglobin A1c

时间窗: 24 months

Hemoglobin A1c

次要结局

  • Quality of Life(24 months)
  • Autonomous Self-Regulation(24 months)
  • Medication Adherence(24 months)
  • Diabetes Self-Care Behaviors(24 months)
  • Diabetes Knowledge(24 months)
  • Body mass index(24 months)
  • Perceived Competence(24 months)
  • Healthcare Utilization(24 months)
  • Systolic Blood Pressure(24 months)
  • Diastolic Blood Pressure(24 months)
  • LDL Cholesterol(24 months)

研究者

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

Ben Gerber

Professor of Medicine

University of Illinois at Chicago

研究点 (2)

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