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临床试验/NCT03241212
NCT03241212已完成不适用

Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2017年9月12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
148
试验地点
2
主要终点
Change in knowledge about type 1 diabetes

研究概览

简要总结

This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.

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
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of type 1 diabetes mellitus
  • Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
  • Age 15-20 at study enrollment
  • English literate and English speaking
  • Ability to complete the required surveys
  • Have a personal cell phone with service compatible with EZTexting Platform
  • Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).

排除标准

  • Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
  • Diabetes Diagnosis other than Type 1 Diabetes
  • Inability for the adolescent to respond to text messages (e.g. due to developmental delay)

研究组 & 干预措施

Control

No Intervention

At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review.

Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment.

Texting

Experimental

Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software.

From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.

干预措施: Texting (Behavioral)

结局指标

主要结局

Change in knowledge about type 1 diabetes

时间窗: 6 months from intervention

Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)

次要结局

  • Change in diabetes self-care practices(at 3 months and 6 months)
  • Change in percent of blood glucoses high, in range and low(at 3 months and 6 months)
  • Percent of text messages responded to in the study.(After 6 months of texting intervention)
  • Change in Hemoglobin A1c(at 3 months and 6 months)
  • Change in blood glucose testing frequency(at 3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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