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Идёт набор NCT05819697

Reducing Patient Memory Recall in the Burning Mouth Patient Population

— Наблюдательное Burning Mouth Syndrome

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: FIRE Trial/Track Your Happiness notifications.
Кому может быть актуально
Состояния в реестре: Burning Mouth Syndrome. Базовые параметры: от 18 лет · Все.
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
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Официальное название

FIRE Trial: Reducing Patient Memory Recall in the Burning Mouth Patient Population

Обзор

The goal of this study is to learn about burning mouth syndrome symptoms in real time in patients with burning mouth syndrome. The main questions it aims to answer are: (1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables. With a collaboration between Penn Dental Medicine and Wharton School of Business, our proposal aims to vastly improve the characterization of burning mouth syndrome through the use of a smartphone app and/or text-based notification. Participants will attend 2 study visits where they will complete questionnaires and provide saliva samples and will respond to notifications/text message prompts on their smart phone 3 times a day for 12 weeks.

Подробное описание

This is a prospective study with the aims: (1) To test the ability of a smartphone app to collect repeated observations of individual data to assess fluctuations in BMS symptoms (pain) at multiple points in the day as they happen; (2) To evaluate a panel of salivary biomarkers in patients with burning mouth syndrome (BMS) and to study their relationship with clinical variables.

Participants will attend 2 study visits. Visit 1 of the study will consist of screening during the baseline visit. It will include administration of questionnaires, informed consent, collection of salivary samples, helping to download the app and/or helping to set up the smartphone to receive text notifications, and assisting with the demonstration of taking surveys on smartphones.

Track Your Happiness app, a smartphone and/or text-based notification system to take surveys, will collect data on people's experiences across a random sample of the moments of their lives. Participants will receives notifications 3 times per day at random times, and will be prompted to answer questions related to the burning mouth, to exercise, and a random selection of non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?" Participants will receive these notifications for 12 weeks.

The final study visit (visit 2) will take place 12 weeks after Visit 1. Visit 2 will consist of questionnaires and collection of salivary samples.

Вмешательства

  • Другое FIRE Trial/Track Your Happiness notifications
    All participants will receive notifications to their smart phones 3 times a day for 12 weeks. They will be asked questions related to burning mouth, to exercise as well as non-clinical Track Your Happiness questions, e.g., "Are you interacting with anyone right now?" "How do you feel right now?"

Первичные конечные точки

  • Track Your Happiness App utilization for Burning Mouth Syndrome (BMS) symptom reports in real time [Срок оценки: 12 weeks]
Вторичные конечные точки (1)
  • Salivary Biomarkers [Срок оценки: Baseline and follow up visit (12 weeks after baseline)]

Критерии участия

Критерии включения

  • Individuals aged 18 years and older
  • Willing and able to provide informed consent
  • Have been diagnosed with BMS for at least three months by an Oral Medicine or other specialist
  • Willing to submit a saliva sample
  • Have continuous access to a smartphone

Критерии исключения

  • In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitive or physical impairment)
  • Prior head and neck radiation and/or chemotherapy
  • Medications that modulate or suppress the inflammatory system

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT05819697 · 843642

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗