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Идёт набор NCT07213284

Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial

Без фазы С лечением Pregnancy Pregnancy, Complications Pregnancy Outcomes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MI MOM App.
Кому может быть актуально
Состояния в реестре: Pregnancy, Pregnancy, Complications, Pregnancy Outcomes. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Site Randomized Trial to Evaluate Behavioral Intervention Via Web-Based Application (MI MOM- Michigan Healthy Moms Application) to Improve Pregnancy Outcomes

Обзор

The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is "treatment as usual" and the other is the "MI MOM App" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the "MI MOM App" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the "MI MOM App" will also have the option to contact a community health worker as needed.

Подробное описание

The researchers aim to use a site-randomized design to determine whether the Michigan Healthy Mom (MI MOM) app will improve pregnancy health when used by pregnant women, their supporters (partners, mothers, friends, etc.), and healthcare providers, vs treatment as usual. Specifically, the researchers will test:

1. Whether use of the MI MOM app results in improvements to self-reported app targets (e.g., reducing provider bias, increasing treatment-seeking, service connection, early warning sign awareness, and improving mental health) 2. Whether use of the MI MOM app improved overall pregnancy and postpartum health 3. Whether the app reduced disparities in pregnancy/postpartum health, i.e. between Black and White, rural and urban participants

Вмешательства

  • Поведенческое MI MOM App
    Participants enrolled in the Michigan Healthy Moms (MI MOM) app will receive initial interactive app content followed by regular text messages with information related to pregnancy health, designed to increase patient awareness of warning signs, help them with self-advocacy, and otherwise improve health in pregnancy and postpartum. They will also have online live chat (text) access to a community healthcare worker who can assist them in enrolling in services to improve their health. They will al

Первичные конечные точки

  • Total pregnancy-associated morbidity through one year postpartum [Срок оценки: Start of pregnancy through 1 year postpartum]
  • Pregnancy-Associated Mortality through one year postpartum [Срок оценки: Start of Pregnancy through 1 year postpartum]
  • Composite Index, total number of maternal morbidity and mortality risk factors [Срок оценки: Measured at 6 weeks post-baseline, 35 weeks of pregnancy, 6 weeks postpartum, 6 months postpartum, and 1 year postpartum.]

Критерии участия

Критерии включения

  • Pregnant at 20 weeks gestation or less
  • 18 years of age or older
  • Access to smartphone with text messaging and internet access
  • Speaks English
  • Enrolled in Medicaid for health insurance

Критерии исключения

  • Younger than 18 years old
  • Not pregnant or pregnant with more than 20 weeks gestation
  • No access to a smartphone with text messaging and internet access
  • Not English speaking
  • Not enrolled in Medicaid for health insurance

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 8 центров
  • Shiawasee Health Department — Corunna
  • McLaren Flint OB-GYN — Flint
  • Munson Gaylord OB-GYN — Gaylord
  • Trinity Health OB-GYN — Grand Rapids
  • MidMichigan OB-GYN — Midland
  • Munson Prudenville OB-GYN — Prudenville
  • MyMichigan Sault OB-GYN — Sault Ste. Marie
  • Grand Traverse Women's Clinic — Traverse City

Публикации

  • Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. Site-randomised trial of a multilevel digital intervention to reduce maternal morbidity and mortality: a study protocol. BMJ Open. 2025 Dec 21;15(12):e113340. doi: 10.1136/bmjopen-2025-113340. PMID 41423300
  • Kelpin SS, Margerison CE, McKay AS, Vickers E, Crawford MK, Spencer J, Sikorskii A, Ondersma SJ. A study protocol for a site-randomized trial of a multi-level digital intervention to reduce maternal morbidity & mortality. medRxiv [Preprint]. 2025 Oct 31:2025.10.29.25339066. doi: 10.1101/2025.10.29.25339066. PMID 41282939

Идентификаторы

NCT: NCT07213284 · 00011005 · U54HD113291

Первоисточники (государственные реестры)

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