跳至主要内容
临床试验/NCT03025984
NCT03025984进行中(未招募)不适用

Adherence to a Diabetes Care Regimen Following Text Message Intervention in Pregnant Women With Diabetes

St. Louis University2 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
185
试验地点
2
主要终点
compliant diabetes care

研究概览

简要总结

Diabetes is a common complication of pregnancy that increases risks for both the mother and baby. Poorly controlled diabetes has been associated with very large babies, congenital heart defects, stillbirth, birth trauma, and maternal infections among other complications. Patients with diabetes in pregnancy require more frequent prenatal visits and fetal evaluation, and must shoulder the burden of mastering management of a complicated care regimen. With the ever-expanding world of technology, more healthcare practices are using cell phones, texting, and social media to interact with patients. Use of this technology has been successful in management of chronic diseases and as reminder systems. The investigators propose a randomized clinical trial to investigate patient adherence to recommended care regimen after intervention of a text message reminder and education system.

详细描述

As a part of routine care, pregnant women without known diabetes undergo screening and testing for gestational diabetes either with a two-hour glucose tolerance testing or a one-hour glucose challenge test followed by a three-hour glucose tolerance test in the event of failure of the one-hour test.

Women who have been given the diagnosis of gestational diabetes mellitus (GDM) by failing this diabetes testing and who meet the inclusion and exclusion criteria shall be approached and offered enrollment in the study. Women with known type 2 diabetes mellitus (T2DM) (pre-gestational diabetes) and women diagnosed elsewhere with GDM who meet the inclusion and exclusion criteria will be offered enrollment when they establish prenatal care. Patients who consent to participate in the study shall be randomized to either the intervention or the contact control group. For randomization purposes, an equal number of notecards will be made for the two groups. These will all be placed in sealed envelopes and shuffled. At the time of patient inclusion, an envelope will be selected by the consenting practitioner. If a patient declines receiving text messages but consents to have her medical record reviewed for adherence to her diabetes care regimen and glycemic control, she will be enrolled in the standard of care control group. A baseline hemoglobin A1c (HbA1c) is obtained.

Patients in all groups shall receive initial diabetes education and started on an individualized diabetic diet regimen. Patients with GDM who develop a requirement for either oral medication or insulin will remain in the same group to which they were initially randomized. An HbA1c level is obtained every one to three months during pregnancy as well as near the time of delivery.

Patients in the intervention group will receive reminders based on their individual disease treatment. A text message shall be sent one day (12 to 36 hours) before appointments to remind about the appointment and with instructions to bring glucose and food records to the appointment. If medication changes are made at the appointment, the patient will receive a text message reminder the day after her appointment to reinforce the regimen. Postpartum patients who had GDM will receive a text message reminder to complete their glucose tolerance test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10 weeks postpartum if the testing is not completed. Women with T2DM will be reminded to bring glucose and food records to their postpartum visits. Participants will be contacted through Google Voice which is a Google system requiring a secure login and password.

Patients in the contact control group will be enrolled in the text4baby program with assistance from a healthcare provider. As the study will conclude upon the patient's postpartum visit, she will be offered the option of discontinuing messages, which otherwise would continue through the infant's first year of life.

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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The patient is a pregnant person 18 years of age or older
  • The patient has been diagnosed with gestational diabetes or is a patient with known diabetes and a confirmed viable pregnancy
  • The pregnancy has a singleton pregnancy
  • The patient has access to a cellular phone with a text messaging plan

排除标准

  • The patient does not have a cellular phone
  • The patient becomes hospitalized for a pregnancy complication for the remainder of pregnancy
  • The fetus has a chromosomal or non-chromosomal malformation

结局指标

主要结局

compliant diabetes care

时间窗: up to 12 months

Compliant with appointments, maintaining diabetes records, and medications, including glycemic control and pregnancy complications.

次要结局

未报告次要终点

研究者

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

Dorothea Mostello, MD

Principal Investigator

St. Louis University

研究点 (2)

Loading locations...

相似试验