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临床试验/NCT01343056
NCT01343056已完成不适用

Program Reinforcement Impacts Self Management

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2011年4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
141
试验地点
2
主要终点
Hemoglobin A1C (HbA1C, %)

研究概览

简要总结

Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm, randomized study with each group receiving a different method of follow up. The 4 arms will be evaluated based on clinical indicators, goal achievement and patient satisfaction.

详细描述

As the diabetes burden worsens, the need for people to become more involved in self-management will increase. Research has demonstrated that diabetes self-management education (DSME) can improve HbA1C levels by 0.76%. While the rates of diabetes are increasing, the numbers of educators available are shrinking. This is a particular hardship in underserved and military communities where the supply of health care providers is already scarce. Our investigative team has led efforts in supporting DSME in the PA state-wide deployment of the Chronic Care Model (CCM) and reported findings nationally on innovative ways to increase the pool of education services by integrating educators into primary care, establishing nurse clinics in underserved communities and demonstrating that an educator position could be sustained by reimbursement. A 0.76% reduction associated to DSME can be considered an enormous benefit and is equivalent to the impact of most pharmacologic treatments for diabetes. Unfortunately, however the benefits of DSME decrease over time. This suggests that sustained improvements require contact and follow-up. SMS is defined as the process of ongoing support of patient self-care, to sustain the gains following DSME. There is often confusion among the terms self-management education (DSME) and self-management support (SMS). DSME is associated with the provision of knowledge and skills training delivered by a health care professional, e.g. nurses, dietitians, etc. SMS is defined as the process of making and refining changes in health care systems (and the community) to support patient self-care and maintain the gains made following DSME. We know that SMS is currently provided by diabetes educators, but only one 3-6 month follow up is usual care. It has been suggested that SMS can be provided by community workers, peers with diabetes, and office staff within community sites, like PCP offices, and wellness centers, etc. The National Standards for DSME and American Diabetes Association (ADA) Education Recognition Program (ERP) require that SMS approaches be delivered and documented, yet no evidence has been provided to define who should deliver it and how often. This uncertainty has led to many programs delivering SMS in an unstructured, non-standardized and at times haphazard fashion. Practical approaches designed for providing SMS have the potential to sustain improvements. The objective of this study is to compare Self-Management Support (SMS) interventions following Diabetes Self-Management Education (DSME) and determine which will be more likely to maintain improvements in behavioral and clinical outcomes following DSME while achieving patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •A person with diabetes referred for diabetes education

排除标准

  • •Gestational diabetes and pregnancy
  • •If a person has recently had diabetes education, they will not be enrolled in the study

研究组 & 干预措施

Office Staff follow up education

Active Comparator

A designee in the office staff shall be assigned to follow up with the patient for for behavioral goal setting attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.

The intervention is the follow up goal attainment and office staff have been trained on elements of goal attainment.

干预措施: Office Staff Support (Behavioral)

Peer follow up education

Active Comparator

A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor behavioral goal attainment.The intervention is the follow up goal attainment and peers have been trained on elements of goal attainment.

干预措施: Peer Support (Behavioral)

Usual Care

Active Comparator

ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator. The intervention is the diabetes educator making a phone call to the patient to ask how they are doing.

干预措施: Usual Care Support (Behavioral)

Educator support follow up

Active Comparator

A diabetes educator will provide follow up support and make monthly call to the patient to ascertain behavioral goal setting attainment. The diabetes educator uses behavioral goal setting as an education intervention. The educator calls patient to determine goal attainment. That is the intervention.

干预措施: Educator Support (Behavioral)

结局指标

主要结局

Hemoglobin A1C (HbA1C, %)

时间窗: 6 months

次要结局

  • Total Cholesterol (mg/dL)(6 months)
  • High Density Lipoprotein (HDL, mg/dL)(6 months)
  • Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores(6 months)
  • Diastolic Blood Pressure(6 months)
  • Body Mass Index(6 months)
  • Systolic Blood Pressure(6 months)
  • Low Density Lipoprotein (LDL, mg/dL)(6 months)

研究者

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

Linda Siminerio

Linda Siminerio, RN, PhD, CDE, Executive Director

University of Pittsburgh

研究点 (2)

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