跳至主要内容
临床试验/NCT00998595
NCT00998595已完成不适用

Es Mejor Saber: A Proactive Approach to Gestational Diabetes Follow Up

University of Southern California1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2009年6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
216
试验地点
1
主要终点
the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.

研究概览

简要总结

The primary hypothesis underlying this proposal is that the introduction of a Promotora to provide education and proactive follow-up to women with GDM will increase compliance with postpartum glucose tolerance testing. The secondary hypothesis is that the Promotora will improve participation in referral visits for diabetes or preventive care. We will develop the promotora program and begin pilot implementation.

详细描述

As Los Angeles County + University of Southern California Medical Center (LAC+USC) serves an indigent Latino population at increased risk for developing Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus (GDM) complicated 13% of deliveries at LAC+USC between 2006-2007. While over 50% of GDM patients will develop overt diabetes mellitus within a decade of the incident pregnancy, less than half of these patients ever return for even one post-partum follow up visit at this institution (45%). Lifestyle Interventions and medications have been shown to delay or prevent the onset of T2DM. However, prevention is only possible if patients follow-up and individual risk assessment is made. While identifying the 2-hour glucose tolerance test as the appropriate postpartum screening technique for patients with a history of GDM, the Fifth International Workshop-Conference on Gestational Diabetes Mellitus did not identify strategies to improve follow up among this patient population. Promotoras (bi-lingual, bi-cultural lay community health workers representative of the Latino community base) have been successful in improving follow up for other areas of diabetes and women's preventive services but have not been studies in the context of GDM. We will develop the Es Mejor Saber training materials and program and pilot a randomized control trial (RCT),a total 216 subjects completing a GDM affected pregnancy will be randomized on the postpartum ward to the standard-of-care versus proactive follow-up with a Promotora. The Promotora will provide education, address barriers to follow-up, remind subjects of their appointments, and call them to reschedule if they miss appointments. In the first phase of the study, these appointments will include the OGTT and the initial postpartum visit. In the second phase, these visits will include referrals to internal medicine (for those diagnosed with T2DM) or nutrition counseling (for those found not to have diabetes). The primary hypothesis underlying this proposal is that the introduction of a Promotora providing education and pro-active follow-up into postpartum GDM management will result improve post-partum follow-up for screening, treatment, and preventive services when compared with the standard of care.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Diagnosed with diabetes for the first time during the most recent pregnancy
  • •Completed pregnancy >20 weeks duration
  • •Has access to a telephone
  • •Is willing to be contacted by the Promotora
  • •Is willing to follow-up at LAC+USC for postpartum visit
  • •Able to give informed consent
  • •Age ≥18 years
  • •Residence within 60 miles of LAC+USC
  • •ON INPATIENT WARD AT LAC+USC AT TIME OF RECRUITMENT

排除标准

  • •Diagnosis of diabetes prior to most recent pregnancy (pre-gestational diabetes)
  • •Current ICU admission during delivery hospitalization that would interfere with recruitment and participation in the study
  • •Currently residing in jail or inpatient psychiatric facility
  • •Postpartum day #1-2, any Fasting Blood Glucose ≥126mg/dL or random BG≥200mg/dL
  • •Plans postpartum follow-up at non-participating postpartum clinic location
  • •A Medical Record Abstraction Only Cohort is a third group of patients who live within 60 miles of LAC+USC, plan to obtain postpartum care at LAC+USC, and completed a GDM affected pregnancy but refuse participation or do not qualify based on the following: elevated glucose consistent with diagnosis of T2DM or maintained on insulin postpartum, incarceration or resides in inpatient psychiatric facility, age <18, no telephone, unwilling to be contacted by Promotora, or are unable to consent for participation.This cohort can not be enrolled in the study but data is abstracted from the medical records to compare demographics and follow up in our study to all patients with GDM who deliver at LAC+USC.

研究组 & 干预措施

Promotora

Experimental

This group receives additional education and proactive follow-up by removing barriers to already existing services and reminders by a lay community health workers (Promotora)

干预措施: Promotora (Other)

Standard of Care

No Intervention

These subjects receive the routine standard of postpartum care

结局指标

主要结局

the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.

时间窗: 4-12 weeks post partum

次要结局

  • the fraction of women in each group that attends a referral visit(within 8 weeks following referral)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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