Dulce Digital-Project Dulce 2.0 Texting Study in High Risk Latinos With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Randomized controlled trial testing the efficacy of a text messaging intervention in a low income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address barriers to participation in health education classes, increasing adherence to treatment and medications and improving diabetes self management behaviors and skills. Two community clinic organizations that provide services to a large proportion of Latino patients with type 2 diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes management care (control) only or text messaging and standard care. Comparisons between groups will evaluate clinical, behavioral and psychosocial outcomes.
Intervention: Standard Care and Text Messaging. All participants will receive standard diabetes care provided by primary care providers at the clinic. Of the 100 that are randomized to the intervention arm will be given instructions on how the text messaging component will be addressed throughout the duration of the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75,
- •Type 2 DM,
- •Enrolled at community health center,
- •Latino ethnicity,
- •non Project Dulce participant,
- •HbA1c>/= 8%, must be able to read
排除标准
- •Have a severe illness precluding frequent visits to the clinic,
- •have a severe medical condition, poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study, any history of malignancy, except subjects who have been disease-free for >10 years, or whose only malignancy has been basal or squamous cell skin carcinoma,
- •patients who have a creatinine level greater than 3.5,
- •any history of drug or alcohol abuse within 12 months prior to the study,
- •those who are not a permanent resident in the area.
- •Patients who are not willing to use a cell phone with texting capability.
结局指标
主要结局
HbA1c
时间窗: 6 months
次要结局
未报告次要终点
研究者
Athena Philis-Tsimikas
Corporate Vice President
Scripps Whittier Diabetes Institute