Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

Официальное название

IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants

Обзор

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.

Вмешательства

• Поведенческое Diabetes Self-Management Education and Support (DSMES) Videos
  Text message-delivered video-based DSMES intervention.
• Поведенческое Community Health Worker Support (CHW)
  Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.

Первичные конечные точки

• Change in Hemoglobin A1C (HbA1c) Test Scores [Срок оценки: Baseline, Month 6]
• Change in Hemoglobin A1C (HbA1c) Test Scores [Срок оценки: Baseline, 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]
• Summary of Diabetes Self-Care Activities (SDSCA) Score [Срок оценки: Baseline]
• Summary of Diabetes Self-Care Activities (SDSCA) Score [Срок оценки: Month 6]
• Summary of Diabetes Self-Care Activities (SDSCA) 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]
• National Cancer Institute Dietary Screener Questionnaire Score [Срок оценки: Baseline]
• National Cancer Institute Dietary Screener Questionnaire Score [Срок оценки: Month 6]
• National Cancer Institute Dietary Screener Questionnaire Score [Срок оценки: Month 12]

Критерии участия

Критерии включения

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.

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

Идентификаторы

NCT: NCT06319703 · 22-00634

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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