LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c) Levels
研究概览
简要总结
The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese Americans with uncontrolled type 2 diabetes in NYC.
详细描述
Participants will be randomized with equal allocation to one of the 3 groups. The VIDEO group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The VIDEO+CHW group will receive the same DSMES videos plus bi-weekly support calls from a CHW for 24 weeks. The CHW will assess participants' social determinants of health (SDOH) barriers to type 2 diabetes care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.
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
- •self-identify as ethnically Chinese;
- •be above 18 years old;
- •have a diagnosis of Type 2 diabetes (T2D) in the medical record;
- •have an HbA1c≥7% in the past 12 months
- •be willing to participate in video-based interventions; and
- •possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
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);
- •unwilling to accept randomization assignment;
- •is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study; or
- •is breastfeeding (e.g., they may have potential dietary restrictions).
研究组 & 干预措施
CONTROL
Participants assigned to the CONTROL group will continue to receive usual care. At the end of the study, they will receive DSMES videos.
VIDEO
Participants assigned to the VIDEO arm will receive one brief Diabetes Self-Management Education and Support (DSMES) video per week for 24 weeks. The videos will be delivered via text message.
干预措施: Video-Based Diabetes Self-Management Education and Support (DSMES) (Behavioral)
VIDEO+CHW
Participants assigned to the VIDEO+CHW arm will receive one brief DSMES video per week, in addition to bi-weekly support calls from a community health worker (CHW), for 24 weeks. The DSMES videos will be delivered via text message.
干预措施: Video-Based Diabetes Self-Management Education and Support (DSMES) (Behavioral)
VIDEO+CHW
Participants assigned to the VIDEO+CHW arm will receive one brief DSMES video per week, in addition to bi-weekly support calls from a community health worker (CHW), for 24 weeks. The DSMES videos will be delivered via text message.
干预措施: Community Health Worker (CHW) Support (Behavioral)
结局指标
主要结局
Hemoglobin A1c (HbA1c) Levels
时间窗: Month 12
Hemoglobin A1c (HbA1c) Levels
时间窗: Baseline
Hemoglobin A1c (HbA1c) Levels
时间窗: Month 6
次要结局
- International Physical Activity Questionnaire (IPAQ) Short-Version Score(Month 12)
- Stanford Self-Efficacy for Diabetes Scale Score(Month 12)
- Starting the Conversation (STC) Diet Scale Score(Month 12)
- Stanford Self-Efficacy for Diabetes Scale Score(Baseline)
- Stanford Self-Efficacy for Diabetes Scale Score(Month 6)
- Starting the Conversation (STC) Diet Scale Score(Baseline)
- Starting the Conversation (STC) Diet Scale Score(Month 6)
- Adherence to Refills and Medications Scale for Diabetes (ARMS-D)(Baseline)
- Adherence to Refills and Medications Scale for Diabetes (ARMS-D)(Month 6)
- Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales(Baseline)
- Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales(Month 6)
- Diabetes-Related Distress(Baseline)
- Diabetes-Related Distress(Month 6)
- Diabetes-Related Distress(Month 12)
- SDOH Barriers(Baseline)
- SDOH Barriers(Month 6)
- SDOH Barriers(Month 12)
- Health-Related Social Needs(Baseline)
- Health-Related Social Needs(Month 6)
- Health-Related Social Needs(Month 12)
- Cognitive Function(Baseline)
- Cognitive Function(Month 6)
- Cognitive Function(Month 12)
- Stanford Self-Efficacy for Diabetes Scale Score(Month 12)
- Starting the Conversation (STC) Diet Scale Score(Month 12)
- International Physical Activity Questionnaire (IPAQ) Short-Version Score(Month 12)
- Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales(Month 12)
- Adherence to Refills and Medications Scale for Diabetes (ARMS-D)(Month 12)
- International Physical Activity Questionnaire (IPAQ) Short-Version Score(Baseline)
- International Physical Activity Questionnaire (IPAQ) Short-Version Score(Month 6)