Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
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: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART).
- Кому может быть актуально
- Состояния в реестре: Pregnancy. Базовые параметры: 21 лет — 45 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
- Сингапур
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study aims to test the following hypotheses in a single-arm observational study in 70-100 healthy pregnant multi-ethnic women who will be followed-up from the first trimester of pregnancy to the third trimester of pregnancy. Aim 1: To assess the applicability, acceptability and compliance with the use of a wearable smart ring together with smart digital devices (e.g., smart phone) during pregnancy. Hypothesis 1: The investigators hypothesize that participants will respond favorably to the use of the smart ring to monitor their physical activity and sleep during pregnancy. Aim 2: To assess the association between maternal characteristics (age, pre-pregnancy BMI, pregnancy weight gain, stress, anxiety and depression symptoms) with physical activity markers (energy expenditure, and step count) and sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability) collected from the smart ring in the second trimester of pregnancy. Hypothesis 2: The investigators hypothesize that specific maternal characteristics will be associated with physical activity markers (energy expenditure, and step count), as well as sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability).
Подробное описание
Wearable sensor and other smart technologies may play an important part in the early detection of adverse pregnancy-related health events along with motivating improvement in patient and provider interactions for effective pregnancy health management. The use of wearable sensors, more specifically, wearable smart rings can potentially be used to offer remote, unobtrusive personalized care, encourage preventive care and provide the necessary context for self-help based just-intime adaptive interventions (feedback loops utilizing digital phenotyping data to trigger in-app interventions). Studies on the use of wearable smart rings and health outcomes are scarce, and currently there is no available data of the use of wearable smart rings together with smart digital devices (i.e., smart phone) for tracking pregnancy health in women. This study aims to be the first to generate preliminary pilot data to support it's use in this specific group of women.
An observational period for up to 37 weeks, single-center, one-armed intervention study involving 70-100 healthy pregnant women from a multi-ethnic population (Chinese, Malay, Indian, others) aged between 21 and 45 years.
All participants included into the study will be provided an Oura Ring to wear for the rest of the pregnancy period.
Data will be collected through questionnaires and each time a participant opens up their mobile application, the uploaded data will be automatically transferred via Bluetooth connection to the study database in the smart ring cloud service. The questionnaires include socio-economic factors, maternal anxiety and depression, maternal sleep, and maternal physical activity. The participants data will be collected from the moment join the study up till delivery.
Вмешательства
- Другое Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Single-arm observational study where all participants in the study will be given a smart ring (Oura Ring) to wear throughout the duration of the study.
Первичные конечные точки
- Feasibility and applicability of smart ring usage during pregnancy [Срок оценки: At the end of pregnancy]
Вторичные конечные точки (11)
- Objective change in sleep quality across the entire pregnancy [Срок оценки: up to 37 weeks from recruitment]
- Self-reported change in sleep quality [Срок оценки: First trimester of pregnancy between 0-12 weeks gestational age]
- Self-reported change in sleep quality [Срок оценки: Second trimester of pregnancy between 13-27 weeks gestational age]
- Self-reported change in sleep quality [Срок оценки: Third trimester of pregnancy between 28-40 weeks gestational age]
- Objective change in physical activity across the entire pregnancy [Срок оценки: up to 37 weeks from recruitment]
- Self-reported change in physical activity [Срок оценки: First trimester of pregnancy between 0-12 weeks gestational age]
- Self-reported change in physical activity [Срок оценки: Second trimester of pregnancy between 13-27 weeks gestational age]
- Self-reported change in physical activity [Срок оценки: Third trimester of pregnancy between 28-40 weeks gestational age]
- Anxiety and depression symptoms [Срок оценки: First trimester of pregnancy between 0-12 weeks gestational age]
- Change in anxiety and depression symptoms across the first, second and third trimesters [Срок оценки: Second trimester of pregnancy between 13-27 weeks gestational age]
- Change in anxiety and depression symptoms across the first, second and third trimesters [Срок оценки: Third trimester of pregnancy between 28-40 weeks gestational age]
Критерии участия
Критерии включения
- From the first to third trimester of pregnancy (4-39 weeks of gestational age)
- Mobile phone's operating system supported by the smart ring application.
- Aged 21 and above
Критерии исключения
- Can't read or speak English
- Below 21 years of age
- Below or above gestational age limit
- Limited mobility
- Diagnosed with severe unstable mental conditions
- Diagnosed with severe chronic disorders
- Mobile device not compatible with smart ring
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Сингапур · 1 центр
- KK Women's and Children's Hospital — Singapore
Идентификаторы
NCT: NCT05709327 · 2021/2515