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Набор скоро начнётся NCT07416734

RCT of HeartBot in Women

Без фазы С лечением Participants Must be Women Aged 25 Years or Older Participants Should Have no Self-reported History of Heart Disease or Stroke Participants Should Have no Terminal Illness or Diagnosed Cognitive Impairment, Including Alzheimer's Disease Participants Should Not be a Healthcare Professionals or Healthcare Trainees

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: HeartBot II Program, Waitlist Control.
Кому может быть актуально
Состояния в реестре: Participants Must be Women Aged 25 Years or Older, Participants Should Have no Self-reported History of Heart Disease or Stroke, Participants Should Have no Terminal Illness or Diagnosed Cognitive Impairment, Including Alzheimer's Disease, Participants Should Not be a Healthcare Professionals or Healthcare Trainees. Базовые параметры: от 25 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
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Официальное название

Efficacy of the Artificial Intelligence HeartBot II in Increasing Awareness and Knowledge of Heart Attack in Women: Study Protocol for a Randomized Controlled Trial With a Waitlist Control

Обзор

The goal of this clinical trial is to find out whether an app-based program called HeartBot II, which uses an artificial intelligence (AI) chatbot, can help improve women's awareness and knowledge of heart attacks in women. This is an online study with about 200 women taking part. Participants will be randomly assigned (by chance) to one of two groups: an intervention group or a wait-list control group. Participants in the intervention group will begin using the HeartBot II program right away. Participants in the wait-list control group will wait 12 weeks before starting the HeartBot II program. The HeartBot II program includes four short modules. In each module, participants will interact with a chatbot and spend about 10 to 15 minutes completing the content. Participants will be asked to complete an online screening and baseline survey at the start of the study, as well as two follow-up surveys at 12 weeks and 24 weeks.

Подробное описание

We conducted a series of studies to evaluate the feasibility, acceptability, and potential efficacy of an AI chatbot (HeartBot I) in increasing women's awareness and knowledge of heart attack symptoms and appropriate care-seeking behavior. The results of those studies and HeartBot I design details were published elsewhere. In brief, HeartBot I was feasible (i.e., no withdrawal from HeartBot I conversation) and accepted by women, and its interactions were significantly associated with improvements in awareness and knowledge of all heart attack outcomes. However, since HeartBot I was a rule-based chatbot, its behavior and responses were limited to content authored specifically for HeartBot I conversations. To improve HeartBot I's capacity, we incorporated all women's heart attack and relevant questions collected in our previous studies and expanded its knowledge bank to enable more educational conversations. To achieve more human-like natural and personalized conversations, we implemented a new version of HeartBot (HeartBot II) powered by an LLM, specifically gemini-2.5-flash through the Google Conversational Agents platform.

Вмешательства

  • Другое HeartBot II Program
    Participants assigned to the intervention group will receive the HeartBot II intervention during the first 12 weeks. Participants in the intervention group will download the HeartBot II application on their smartphone, register their account with the access code provided by the research team, and will be asked to start Module 1 immediately after randomization. The HeartBot II application consists of 4 module and each module is scheduled approximately 3 weeks apart. It will take about 13 minutes
  • Другое Waitlist Control
    The waitlist control group will not receive the HeartBot II intervention during the initial 12-week period, but will receive a text message once week for 12 weeks for attention control. These text messages do not include any educational content related to heart attack or heart health and are limited to neutral study reminders and general self-report prompts. Following completion survey at week 12, participants in the waitlist control group will initiate the HeartBot II program, delivered identic

Первичные конечные точки

  • Awareness and knowledge of symptoms and response to a heart attack [Срок оценки: Baseline, week 12, week 24]
Вторичные конечные точки (2)
  • HeartBot II evaluation [Срок оценки: Baseline, week 12, week 24]
  • Perceived risk of heart attack [Срок оценки: Baseline, week 12, week 24]

Критерии участия

Критерии включения

  • Women
  • 25 years or older
  • Living in the US
  • University of California, San Francisco Health patient
  • Possessing a smartphone with a data plan or Wi-Fi access

Критерии исключения

  • Individuals who identify as male
  • Having self-reported cognitive impairment
  • Having history of heart disease or stroke
  • Healthcare professional/trainee
  • Working in the healthcare field

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
Профилактика

Центры проведения

США · 1 центр
  • University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07416734 · 25-44825

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗