Family Model DSME in FBOs in the RMI

Официальное название

Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands

Обзор

Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.

Вмешательства

• Поведенческое Family Model Diabetes Self-Management Education and Support
  Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.
• Поведенческое Family Model Diabetes Self-Management Education and Support (Wait-list)
  Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.

Первичные конечные точки

• Glycemic control, measured by change in mean HbA1c (%) from baseline [Срок оценки: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention]

Критерии участия

Критерии включения

• self-reported Marshallese
• 18 years of age or older
• have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
• have at least one family member willing to take part in the study

Критерии исключения

• has received diabetes self-management education in the past five years
• has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
• plans to move out of the geographic region

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• UAMS Institute for Community Health Innovation — Springdale

Идентификаторы

NCT: NCT05502016 · 263202 · 1R01DK128145-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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