Randomized Pilot Trial of AYUDA Program for Younger Latinx Adults With Type 2 Diabetes

Официальное название

Tailoring Initial Type 2 Diabetes Care to Meet the Needs of Younger Latinx Adults: A Randomized Pilot Study

Обзор

The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.

Подробное описание

After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children.

AYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.

Вмешательства

• Поведенческое AYUDA Program
  Participants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members.

Первичные конечные точки

• Differences between study arms in HbA1c change 6-months following enrollment [Срок оценки: 6-months following enrollment]

Вторичные конечные точки (9)

• Healthcare contact [Срок оценки: 6-months following enrollment]
• Completion of recommended HbA1c monitoring [Срок оценки: 6-months following enrollment]
• T2D-related medication initiation [Срок оценки: 6-months following enrollment]
• T2D-related medication adherence [Срок оценки: 6-months following enrollment]
• Use of remote glucose monitoring to measure glucose levels [Срок оценки: 6-months following enrollment]
• Participant-reported measures: Diabetes distress [Срок оценки: Study enrollment and 6-months following enrollment]
• Participant-reported measures: Motivation and locus of control [Срок оценки: Study enrollment and 6-months following enrollment]
• Participant-reported measures: Care Experience [Срок оценки: Study enrollment and 6-months following enrollment]
• Participant-reported measures: Children's Behaviors [Срок оценки: Study enrollment and 6-months following enrollment]

Критерии участия

Критерии включения

• KPNC member, age >18 and age <45 with
• New clinical diagnosis of T2D within the prior 6 months
• Caregiver to at least one child <18 years of age at time of diabetes diagnosis
• Identifies at Latino/a/x
• Can receive text messages
• Proficient (written and spoken) in English or Spanish

Критерии исключения

• Pregnant women
• Type 1 Diabetes

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

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Kaiser Permanente Northern California — Pleasanton

Идентификаторы

NCT: NCT07019649 · 2225114-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗