NYULMC-CareSmarts Study: A Pilot Study to Determine the Feasibility, Acceptability, and Potential Efficacy of an SMS-based Mobile Intervention to Enhance Type 2 Diabetes Self-management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Measure of glucose
研究概览
简要总结
CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Individuals will be randomly assigned with equal allocation to either the CareSmarts intervention or to usual care for 6 months.
详细描述
CareSmarts is a mobile diabetes program that provides self-management support and team-based care management for people with diabetes through automated SMS messages. The program is a theory-driven behavioral intervention designed to improve self-care through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Participants in the program receive educational and motivational text messages about diabetes self-care, some prompts to engage in a particular action (for example, "Time to check your blood sugar"), and some self-assessment questions (such as, "Do you need refills of any of your medications?") to which the patient responds by texting. Participants' responses to self-assessment questions are used to facilitate remote monitoring and care management by the health care team. A response that is outside established parameters triggers an alert. Using protocols, nurses respond to each alert by the next business day.
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
- Single (Participant)
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
- •have a DRG Code of T2D, and be prescribed at least one oral T2D drug and/or insulin.
- •must own an SMS capable mobile device and be willing to send and receive SMS messages regarding T2D self-management.
- •The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that targets an HbA1c <7%.
排除标准
- •unable or unwilling to provide informed consent
- •unable to participate meaningfully in an intervention that involves use of SMS messages (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking)
- •unwilling to accept randomization assignment
- •pregnant, plans to become pregnant in the next 6 months, or who become pregnant during the study
- •gestational diabetes
- •breastfeedling
- •individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
结局指标
主要结局
Measure of glucose
时间窗: 3 Months
Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
时间窗: 3 Months
Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
时间窗: 3 Months
Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
时间窗: 3 Months
次要结局
未报告次要终点