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临床试验/NCT00652509
NCT00652509已完成不适用

Journey for Control of Diabetes Study

Merck Sharp & Dohme LLC0 个研究点目标入组 621 人开始时间: 2008年5月1日最近更新:
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
621
主要终点
Program satisfaction, behavioral and emotional outcomes.

研究概览

简要总结

Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar goals, but most care systems do not provide effective support to assist patients in successful ongoing self-management. After initial education, many programs are limited by allowable Medicare reimbursement for diabetes education which currently requires physician referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of nutritional services. These services are usually provided either on an individual basis or occasionally through a traditional group class approach. For patients with established type 2 diabetes who are not achieving optimal glycemic control, we propose to develop and formally evaluate in a randomized trial a novel group experience to educate and motivate patients with established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood sugar control levels to one of 3 study groups: (1) IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients (2) Individual Education (IE) - patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual care (UC)- patients receive no research intervention. The primary analyses will involve mixed model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12 months. Depending on 12 month results, a longitudinal four year post intervention analysis is planned to assess sustainability of treatment effects and cost-effectiveness.

研究设计

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

入排标准

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

入选标准

  • •Type 2 Diabetes Mellitus

排除标准

  • •Gestational diabetes
  • •Type 1 Diabetes Mellitus

研究组 & 干预措施

1

Experimental

IDEA

干预措施: Interactive Dialogue to Educate and Activate (IDEA) (Behavioral)

2

Active Comparator

IE

干预措施: Individual Education (IE) (Behavioral)

3

No Intervention

UC: Patients receive no research intervention.

结局指标

主要结局

Program satisfaction, behavioral and emotional outcomes.

时间窗: 3, 6, 9, 12 months after implementation of intervention

次要结局

  • Blood sugar level, blood pressure, lipids, cost, comorbidities.(6, 12, 18, 24, 36, and 48 months after intervention)

研究者

申办方类型
Industry
责任方
Sponsor

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