Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.
详细描述
Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. This study uses a SMS strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n=100). Outcomes will be measured at 0, 3, 6, &9 months. Aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH and providers.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homeless person age ≥ 21
- •Diagnosed with type 2 DM
- •Most recent visit HbA1c ≥ 8%
- •English/Spanish speaking
- •Connected to study sites' shelter-clinics for care
排除标准
- •Pregnant or within 3 months postpartum
- •Has an uncontrolled severe illness
- •Has had a heart attack or stroke in the previous 6 months
- •Inability to read/respond to texts
- •Inability to provide informed consent
- •Receiving inpatient care for severe substance abuse
研究组 & 干预措施
Intervention
The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support.
干预措施: Intervention (Behavioral)
Control
The control (CL) will receive 6 months of texts for general health promotion.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Change in HbA1c
时间窗: 9 months
Hemoglobin A1c level
次要结局
- Summary of Diabetes Self-Care Activities (SDSCA)(9 months)
- Appointment Adherence(9 months)
- Proportion of Days Covered (PDC)(9 months)
研究者
Ramin Asgary
Associate Professor School oh Public Health, PI
George Washington University