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临床试验/NCT02049359
NCT02049359已完成不适用

Use of a Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetic Patients (SAMI TRIAL)

Campbell University, Incorporated6 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
6
主要终点
Change From Baseline A1C

研究概览

简要总结

The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.

详细描述

This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C >9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.

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

入选标准

  • New or existing patient of Carolina Family Health Centers Inc. (Wilson Community Health Center, Harvest Family Health Center, Freedom Hill Community Health Center)
  • Diagnosis of diabetes
  • Single serum hemoglobin A1C equal to or greater than 9% within 2 weeks of study enrollment
  • Below 200% of 2013 poverty level
  • Currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period

排除标准

  • Anemia diagnosed within past 3 months
  • Blood transfusion within the past 3 months
  • unable to read English at the fifth grade level

结局指标

主要结局

Change From Baseline A1C

时间窗: 12 weeks

Change in A1C from baseline

次要结局

  • Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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