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临床试验/NCT01546844
NCT01546844Unknown不适用

Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management

HealthInsight60 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
HealthInsight
入组人数
500
试验地点
60
主要终点
Change in Hemoglobin A1c - In control, over time.

研究概览

简要总结

This purpose of this is study is to evaluate the effectiveness of an interactive mobile health information service, Care4Life, in supporting patient self-management of Type II Diabetes Mellitus.

详细描述

This study evaluates the effectiveness of an interactive mobile health information service, Care4Life, in supporting patient self-management through its ability to facilitate patient education, behavior change, and improved adherence with standard care practices. The study population comprises adults who have been diagnosed with Type 2 diabetes mellitus (DM) and a hemoglobin A1c (HbA1c) test above 8% in the past year. All members of the study population are treated at primary care clinics under the auspices of the Utah Beacon Community Program, which aims to improve health through use of health information technology. We will compare outcomes in two groups within this population: patients with DM who enroll in Care4Life (in addition to receiving standard care) to patients with DM who receive standard care from their physician. We will compare these groups both within the clinic and at an aggregated, overall level.

This study relies on the use of information and communications technology (ICT) in supporting patient-empowerment strategies. Features of successful diabetes care programs for improving adherence to standards of care, such as the use of diabetes self-management education, checklists that mirror guidelines, and automated reminders are well suited to delivery using an interactive mobile health platform.

Research Questions

This study will evaluate the efficacy of the Care4Life mHealth program by:

  1. Evaluating if a short message service via cell phone texting (SMS) protocol will lead to improvements in clinical, utilization and satisfaction outcomes for patients with DM compared to patient who receive standard care.
  2. Evaluating if an SMS protocol can be readily adopted by an adult population in both urban and rural areas with a time-consuming chronic illness.

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
All
接受健康志愿者

入选标准

  • Laboratory test for HbA1c ≥ 8% within the past year
  • Clinical diagnosis of DM
  • Age > 18 years old
  • Patient in a Beacon clinic
  • Cell phone ownership or willingness to acquire a cell phone capable of receiving and sending SMS messages
  • Women who are not pregnant

排除标准

  • Failure to meet inclusion criteria

结局指标

主要结局

Change in Hemoglobin A1c - In control, over time.

时间窗: 3, 6, 9, and 12 months

Hemoglobin A1c - In control as assessed by laboratory results of blood draw taken from patient's clinic. In control means a result of \<9%.

次要结局

  • Change in Blood Pressure Control over time(3, 6, 9, 12 months)
  • Change in BMI over time(3, 6, 9, 12 months)
  • Disease Management(12 months)

研究者

发起方
HealthInsight
申办方类型
Other
责任方
Sponsor

研究点 (60)

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