Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management
试验速览
- 阶段
- 不适用
- 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:
- 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.
- 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
- 否
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)
