Increasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income Vulnerable Immigrants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change in HbA1c levels
研究概览
简要总结
The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.
详细描述
In stage 1, the 8 family health center (FHC) clinics will be randomized 1:1 into Experimental Cohort A, which will receive the Community Health Worker (CHW)-enabled community-clinic linkage model (CCL) or Control Cohort B, with FHCs that will not receive the CHW-enabled CCL. Then, in stage 2, patients in clinics that received the CHW-enabled CCL will be randomized in a 1:1 ratio to Arm A who will receive text-based mhealth diabetes education videos or Arm B who will not receive mhealth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, the patient participant must meet all the following criteria:
- •≥18 years old and ≤ 70 years old
- •Self-identify their primary language as English, Mandarin, Cantonese, or Spanish
- •Diagnosed with T2DM
- •Has their most recent HbA1c ≥8% or have a new diagnosis of T2DM within the past 6 months
- •For patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria
- •1. Willing to receive text messages with brief videos regarding T2DM management
排除标准
- •Unable or unwilling to provide informed consent
- •Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)
- •Is currently pregnant (Pregnant women will be excluded from this study because they may have special dietary restrictions that are not covered by our DSMES videos for the general population with T2DM.)
结局指标
主要结局
Change in HbA1c levels
时间窗: Baseline, Month 6
次要结局
- Level of satisfaction with community-clinic linkage (CCL) and mHealth(Month 12)
- Percentage of patients accepting Community Health Worker (CHW) support(Month 12)
- Percentage of patients accepting mHealth(Month 12)
- Percent completion of social service referrals(Month 6)
- Percent mhealth videos watched(Month 12)