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Набор скоро начнётся NCT07692711

Patient Aid for Theory-Driven Health Communication (PATH): Translating Goal-Power Theory Into an Instrument and Generative AI Support for Palliative Care Communication

Без фазы С лечением Palliative Care Generative Artificial Intelligence Natural Language Processing (NLP)

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: NurseChat+.
Кому может быть актуально
Состояния в реестре: Palliative Care, Generative Artificial Intelligence, Natural Language Processing (NLP). 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
Тайвань
Следующий шаг
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Обзор

The goal of this clinical trial is to learn whether an artificial intelligence (AI)-supported communication tool can help improve communication between people receiving palliative care and their healthcare providers. The study will also evaluate a new questionnaire designed to measure the quality of healthcare communication. The main questions this study aims to answer are: 1. Can the new questionnaire accurately measure the quality of communication between participants and healthcare providers? 2. Does using the AI-supported communication tool, called NurseChat+, help participants feel more confident and prepared before meeting with their healthcare team? 3. Does NurseChat+ improve the quality of communication during palliative care visits? Researchers will compare participants who use NurseChat+ together with their usual care to participants who receive usual care alone to see whether the tool improves communication outcomes. The study will be conducted in three stages. First, researchers will develop and test a questionnaire that measures healthcare communication. Next, they will develop and refine the NurseChat+ tool. Finally, they will test the tool in adults receiving palliative care at National Taiwan University Hospital. Participants in the final stage of the study will be randomly assigned to one of two groups. One group will use NurseChat+ before their scheduled medical visits in addition to receiving usual care, while the other group will receive usual care only. Participants will complete questionnaires about their communication experiences during the study.

Подробное описание

Effective health communication is essential to patient well-being, yet the field is constrained by major theoretical and methodological gaps. Existing theories tend to address isolated communication phenomena and lack an integrative framework spanning the full continuum of patient-provider interaction. As a result, many measurement instruments lack a clear theoretical foundation and demonstrate inconsistent psychometric quality. In parallel, most AI-supported communication tools are technology-driven rather than theory-driven, and few have undergone rigorous clinical evaluation. Palliative care represents a high-stakes clinical context in which communication quality is central to outcomes, making it an ideal setting to test theory-based generative artificial intelligence (GenAI) communication interventions.

Grounded in the Goal-Power Theory of Communication developed by the applicant, this four-year project adopts a mixed-methods design to develop and evaluate a theory-based communication measurement instrument and a GenAI-supported communication aid, NurseChat+. The project comprises three sequential phases: (1) instrument development and validation, (2) intervention development and pilot testing, and (3) clinical evaluation using a randomized controlled trial (RCT). Phase 1 aims to develop and psychometrically validate a theory-based instrument for assessing health communication quality. Instrument development and validation will follow the MEASURE framework, including expert content validation and field testing with approximately 500 participants recruited from clinical settings within the National Taiwan University Hospital system. Phase 2 aims to develop and preliminarily validate the NurseChat+ using a user-centered design approach. A pilot usability and feasibility study will be conducted using a one-group pretest-posttest design with a minimum of 20 healthy adults to assess acceptability, usability, and preliminary effects on communication self-efficacy. Phase 3 will conduct a parallel-group, superiority RCT with an embedded mixed-methods design in palliative care outpatient and home care settings at National Taiwan University Hospital. Eligible adult patients receiving palliative care will be randomly allocated in a 1:1 ratio to the intervention group (NurseChat+ plus usual care) or the control group (usual care alone). The target sample size is 240 participants (120 per group). Intervention participants will use NurseChat+ prior to scheduled medical encounters.

Вмешательства

  • Поведенческое NurseChat+
    Participants will use NurseChat+, a generative AI-supported communication tool, before scheduled palliative care visits to help prepare questions and concerns for discussion with healthcare providers. The intervention is provided in addition to usual care.

Первичные конечные точки

  • Change from Baseline in Communication Self-Efficacy via the 5-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI-5) [Срок оценки: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: immediately following the medical consultation or the interaction with GenAI communication aid).]
  • Quality of Health Communication via the Phase-One Developed Instrument [Срок оценки: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).]
Вторичные конечные точки (6)
  • System Usability Scale (SUS) Score of NurseChat+ [Срок оценки: Post-test (immediately after the interaction with GenAI communication aid).]
  • Inventory of Technology Acceptance Model (ITAM) Score [Срок оценки: Post-test ( immediately after the interaction with GenAI communication aid)]
  • Evaluation of User Experience via the User Experience Questionnaire (UEQ) [Срок оценки: Post-test (immediately after the interaction with GenAI communication aid)]
  • Improvement in Symptom Burden via the Edmonton Symptom Assessment System (ESAS) [Срок оценки: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: post-consultation follow-up within 24-72 hours).]
  • Patient Overall and Communication Satisfaction via the Chinese Patients' Satisfaction Scale (C-PSS) [Срок оценки: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).]
  • Patient Satisfaction with Decision Making via the Satisfaction with Decision (SWD) Scale [Срок оценки: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).]

Критерии участия

Patients (Self-responding)

Критерии включения

  • Age 18 years or older.
  • Diagnosed with an advanced disease requiring consultation with outpatient palliative care clinics or home care services.
  • Able to self-complete the study questionnaires.

Критерии исключения

-None

Group 2: Caregivers (Proxy-responding) (Invited only when the patient meets the clinical criteria but is unable to self-complete the questionnaires)

Критерии включения

  • Age 18 years or older.
  • Identified as the primary family caregiver of a patient with an advanced disease requiring palliative care.

Критерии исключения

  • Professional or paid caregivers.
  • Unable to complete the study questionnaires.

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
Простое слепое
Основная цель
Другое

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07692711 · 202602057RINB

Первоисточники (государственные реестры)

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