跳至主要内容
临床试验/NCT00320112
NCT00320112已完成3 期

Improving Insulin Therapy With Enhanced Care Management and Peer Support

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2007年2月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
244
试验地点
1
主要终点
Change in Glycemic Control (HbA1c)

研究概览

简要总结

VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services; many also lack social support to help them meet the demands of their illness. Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks, such as initiating or intensifying insulin treatment regimens. Although some VAs have implemented telephone nurse care management programs supported by automated calling services, many are reluctant to adopt these models due to nursing shortages.

详细描述

Background:

VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services; many also lack social support to help them meet the demands of their illness. Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks, such as initiating or intensifying insulin treatment regimens. Although some VAs have implemented telephone nurse care management programs supported by automated calling services, many are reluctant to adopt these models due to nursing shortages.

Objectives:

This randomized trial will evaluate an intervention using a low-cost interactive voice response (IVR) exchange system to promote peer-to-peer communication among diabetes patients initiating or increasing insulin therapy under medical guidance. The intervention is based on research demonstrating the positive impact of peer support on chronic disease outcomes and self-care behaviors, our own prior studies demonstrating the effectiveness of IVR-based self-management supports for VA diabetes patients, and a successful pilot study demonstrating VA diabetes patients' willingness to participate in IVR-facilitated peer support. The Specific Aims are: (1) To evaluate the effect of IVR-facilitated peer support on diabetes patients' glycemic control (including their A1c levels, insulin doses, hypo- and hyperglycemic symptoms) and use of VA care; (2) To assess the impact of IVR-facilitated peer support on patient-centered outcomes, including patients' satisfaction with care, perceived social support, diabetes-specific quality of life, and self-care behaviors; and (3) To identify patient characteristics associated with participation and use of IVR peer support, and mediators of the intervention's impact on patient outcomes.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •type 2 diabetes
  • •HbA1c > 7%
  • •age > 21

排除标准

  • •substance abuse disorder
  • •serious psychiatric illness
  • •serious hearing loss
  • •life expectancy < 12 months

研究组 & 干预措施

Reciprocal Diabetes Peer Support program

Experimental

peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.

干预措施: Reciprocal Diabetes Peer Support Program (Behavioral)

Reciprocal Diabetes Peer Support program

Experimental

peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.

干预措施: group outpatient counseling visits (Behavioral)

Nurse Case Management

Other

patients are not paired in the NCM arm. they are provided with educational session on diabetes management and informed of case management services.

干预措施: Nurse Case management (Behavioral)

结局指标

主要结局

Change in Glycemic Control (HbA1c)

时间窗: 6 months (baseline to 6 months)

The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.

次要结局

  • Change in Systolic Blood Pressure Measure(change in blood pressure at 6 months)
  • Number of Participants With Insulin Starts at 6 Months(6 months (baseline to 6 months follow-up))
  • Change in Diastolic Blood Pressure(6 months from baseline)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验