Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
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: LLM-based Chatbot.
- Кому может быть актуально
- Состояния в реестре: Caregivers. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study evaluates the feasibility and acceptability of using the artificial intelligence (AI) chatbot mobile application (an LLM-based Chatbot) to support the well-being of informal care partners of individuals with traumatic brain injury (TBI), dementia, or Huntington disease (HD). Over an 8-week intervention period, up to 60 care partners will engage with the application (app), spending four weeks focusing on physical health and four weeks focusing on mental health. Participants will complete surveys at the midpoint and end of the intervention period. Participants will also complete a semi-structured interview to discuss participants experience using an LLM-based Chatbot. The study team hypothesizes that care partners will find the chatbot acceptable and feasible to use in daily life, and that there will be low attrition and high completion rates of the study.
Вмешательства
- Другое LLM-based Chatbot
Participants will download the app with the study team's help and set it up. The participants will select topics of interest to focus on during the 8-week use of the LLM-based Chatbot. Participants will choose one mental health related topic to focus on from weeks 1-4 and one physical health related topic to focus on from weeks 5-8. During these 4 week cycles the participants will be guided to engage with the app's "Chat" feature, which offers conversational support through interactions with the
Первичные конечные точки
- Feasibility and Acceptability as measured by the Feasibility Questionnaire [Срок оценки: 8 weeks (post intervention)]
Вторичные конечные точки (2)
- Attrition as measured by the percent of participants completing the study [Срок оценки: Baseline to post intervention interview (approximately 8-12 weeks)]
- Adherence as measured by the percentage of missing data over the course of the study [Срок оценки: Baseline to 8 weeks]
Критерии участия
Inclusion Criteria (care partner)
- Age 18 years or older
- Able to independently provide informed consent
- Able to read, speak, and understand English
- Have an Apple (iOS) smartphone, tablet, or laptop, have access to the internet and text messages, and be willing to use these resources for the study, including downloading and using the AI chatbot app (Earkick)
- Be caring for and adult with a medically documented diagnosis of TBI, dementia or Huntington disease (HD)
- Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, dementia, or HD, indicating a response per protocol
- Indicate high levels of caregiver burden, confirmed using the 12-item Zarit Burden questionnaire (scores must be ≥20)
- Willing to complete all study assessments for the duration of their study participation
Inclusion Criteria (care recipient):
- Age 18 years or older
- Have a medically documented diagnosis of TBI, dementia or Huntington disease as noted per protocol
Exclusion Criteria (care partner)
- Anyone not meeting inclusion criteria above
- Professional, paid caregivers
- Anyone at the discretion of the Principal investigator (PI) that would be a preclusion of safe or meaningful participation
Exclusion Criteria (care recipient):
- Anyone not meeting inclusion criteria
- Lives in a care facility (assisted living, nursing home) or is bedbound
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- University of Michigan — Ann Arbor
Идентификаторы
NCT: NCT07280650 · HUM00265379