IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants
概览
- 阶段
- 不适用
- 干预措施
- Diabetes Self-Management Education and Support (DSMES) Videos
- 疾病 / 适应症
- Type 2 Diabetes
- 发起方
- NYU Langone Health
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1C (HbA1c) Test Scores
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D 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.
研究者
入排标准
入选标准
- •Participants must:
- •self-identify as a Chinese immigrant;
- •be between 18-70 years old,
- •have a diagnosis of T2D in the medical record;
- •have had an appointment with a physician for routine T2D care within the past 12 months;
- •have a most recent HbA1c \> or = 8%;
- •be willing to receive brief videos regarding T2D management, 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
DSMES+CHW (IDEAL)
Participants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed.
干预措施: Diabetes Self-Management Education and Support (DSMES) Videos
DSMES+CHW (IDEAL)
Participants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed.
干预措施: Community Health Worker Support (CHW)
Wait-list control group (CONTROL)
Participants in this group will continue to receive the standard of usual care for their T2D at their doctor's office during the course of our study.
结局指标
主要结局
Change in Hemoglobin A1C (HbA1c) Test Scores
时间窗: Baseline, Month 12
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
Change in Hemoglobin A1C (HbA1c) Test Scores
时间窗: Baseline, Month 6
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
次要结局
- Summary of Diabetes Self-Care Activities (SDSCA) Score(Month 12)
- 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)
- National Cancer Institute Dietary Screener Questionnaire Score(Month 12)
- Stanford Self-Efficacy for Diabetes Scale Score(Baseline)
- Stanford Self-Efficacy for Diabetes Scale Score(Month 6)
- Summary of Diabetes Self-Care Activities (SDSCA) Score(Baseline)
- Summary of Diabetes Self-Care Activities (SDSCA) Score(Month 6)
- Starting the Conversation (STC) Diet Scale Score(Baseline)
- Starting the Conversation (STC) Diet Scale Score(Month 6)
- National Cancer Institute Dietary Screener Questionnaire Score(Baseline)
- National Cancer Institute Dietary Screener Questionnaire Score(Month 6)
- International Physical Activity Questionnaire (IPAQ) Short-Version Score(Baseline)
- International Physical Activity Questionnaire (IPAQ) Short-Version Score(Month 6)