LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes

Обзор

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 immigrants with uncontrolled Type 2 diabetes in NYC.

Подробное описание

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.

Вмешательства

• Поведенческое Video-Based Diabetes Self-Management Education and Support (DSMES)
  The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
• Поведенческое Community Health Worker (CHW) Support
  CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.

Первичные конечные точки

• Hemoglobin A1c (HbA1c) Levels [Срок оценки: Baseline]
• Hemoglobin A1c (HbA1c) Levels [Срок оценки: Month 6]
• Hemoglobin A1c (HbA1c) Levels [Срок оценки: Month 12]

Вторичные конечные точки (12)

• Stanford Self-Efficacy for Diabetes Scale Score [Срок оценки: Baseline]
• Stanford Self-Efficacy for Diabetes Scale Score [Срок оценки: Month 6]
• Stanford Self-Efficacy for Diabetes Scale Score [Срок оценки: Month 12]
• Starting the Conversation (STC) Diet Scale Score [Срок оценки: Baseline]
• Starting the Conversation (STC) Diet Scale Score [Срок оценки: Month 6]
• Starting the Conversation (STC) Diet Scale Score [Срок оценки: Month 12]
• International Physical Activity Questionnaire (IPAQ) Short-Version Score [Срок оценки: Baseline]
• International Physical Activity Questionnaire (IPAQ) Short-Version Score [Срок оценки: Month 6]
• International Physical Activity Questionnaire (IPAQ) Short-Version Score [Срок оценки: Month 12]
• Adherence to Refills and Medications Scale for Diabetes (ARMS-D) [Срок оценки: Baseline]
• Adherence to Refills and Medications Scale for Diabetes (ARMS-D) [Срок оценки: Month 6]
• Adherence to Refills and Medications Scale for Diabetes (ARMS-D) [Срок оценки: Month 12]

Критерии участия

Критерии включения

• self-identify as Chinese American;
• be above 18 years old;
• have a diagnosis of Type 2 diabetes (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 of at least 7%;
• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Публикации

• Hu L, Liu J, Yang X, Teng C, Li H, Zhao Y, Levy N, Zhu K, Vang S, Kwon SC, Feldman N, Lau J, Jiang Y, Trinh-Shevrin C, Islam N. Leveraging videos and community health workers to address social determinants of health in immigrants (LINK-IT): Protocol for a randomized controlled trial. PLoS One. 2026 Feb 2;21(2):e0341217. doi: 10.1371/journal.pone.0341217. eCollection 2026. PMID 41628090

Идентификаторы

NCT: NCT06319716 · 23-01274

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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