INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants

Официальное название

Increasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income Vulnerable Immigrants

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое CHW-enabled CCL
  The FHCs has access to the CHW-enabled CCL. With this intervention, participants will be screened for social determinants of health (SDoH) and be referred to care and social services that address any identified needs.
• Поведенческое Mobile health (mHealth) diabetes self-management education and support (DSMES) videos
  Participants will receive 24 culturally tailored DSMES videos through text message.

Первичные конечные точки

• Change in HbA1c levels [Срок оценки: Baseline, Month 6]

Вторичные конечные точки (5)

• Level of satisfaction with community-clinic linkage (CCL) and mHealth [Срок оценки: Month 12]
• Percentage of patients accepting Community Health Worker (CHW) support [Срок оценки: Month 12]
• Percentage of patients accepting mHealth [Срок оценки: Month 12]
• Percent completion of social service referrals [Срок оценки: Month 6]
• Percent mhealth videos watched [Срок оценки: Month 12]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.)

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

Другое

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07296211 · 24-01080 · 5U48DP006778

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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