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Набор скоро начнётся NCT07680894

DockTales for Chronic Pain

Без фазы С лечением Chronic Pain Chronic Pain 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: DockTales, REDCap monitoring.
Кому может быть актуально
Состояния в реестре: Chronic Pain, Chronic Pain Syndrome. Базовые параметры: 18 лет — 88 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

Evaluating Feasibility and Acceptability of DockTales for Chronic Pain

Обзор

This study will evaluate the feasibility and acceptability of DockTales, a mobile health tool designed for adults with chronic pain. DockTales supports pain and sleep tracking through brief diaries, body-map pain reporting, reflective journaling, visual summaries, and optional AI-supported interaction. The study will be conducted completely remotely. Participants will complete 2 weeks of DockTales use and 2 weeks of REDCap-based daily monitoring, with the order randomized. The main goal is to determine whether DockTales is usable, acceptable, engaging, and practical for adults with chronic pain compared with standard REDCap monitoring.

Подробное описание

This is a fully remote, randomized crossover pilot clinical trial designed to evaluate the feasibility and acceptability of DockTales among adults with chronic pain. Chronic pain is defined as pain lasting for more than 3 months. A total of up to 60 participants will be enrolled.

Participants will be randomized in a 1:1 ratio to one of two study sequences. Participants assigned to Sequence 1 will complete 2 weeks of DockTales use followed by 2 weeks of REDCap-based daily monitoring. Participants assigned to Sequence 2 will complete 2 weeks of REDCap-based daily monitoring followed by 2 weeks of DockTales use. All participants will complete both study conditions.

Participants will complete questionnaires at baseline, after the first 2-week period, and after the second 2-week period. These assessments will evaluate feasibility, acceptability, usability, burden, engagement, technical issues, participant preference, and exploratory pain and sleep-related outcomes. Some participants may also complete an optional remote semi-structured interview after finishing both study conditions.

The primary outcomes are feasibility and acceptability. Feasibility will be assessed through recruitment, retention, adherence, completion of DockTales use, completion of REDCap monitoring, missing data, and technical issues. Acceptability will be assessed through satisfaction, engagement, perceived usefulness, ease of use, burden, willingness to use DockTales again, and preference between DockTales and REDCap monitoring.

Вмешательства

  • Поведенческое DockTales
    DockTales includes several core features: 1. Brief diary entries 2. Body-map pain reporting/feedback 3. Reflective journaling 4. Optional AI-supported interaction The AI-supported feature is not intended to provide medical advice, diagnosis, treatment recommendations, mental health care, or emergency support. The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
  • Другое REDCap monitoring
    REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.

Первичные конечные точки

  • Enrollment rate [Срок оценки: At the enrollment]
  • Retention rate [Срок оценки: End of Week 4]
  • Module completion rate [Срок оценки: End of Week 4]
  • Daily survey completion rate [Срок оценки: End of Week 4]
  • Levels of satisfaction [Срок оценки: End of Week 2 and Week 4]
  • Levels of enjoyment [Срок оценки: End of Week 2 and Week 4]
  • Levels of engagement [Срок оценки: End of Week 2 and Week 4]

Критерии участия

Критерии включения

  • Age ( 18-88 years old)
  • English speaker (written and spoken)
  • Chronic pain for at least 3 months
  • Smartphone/text messaging capability

Критерии исключения

  • Any personal history of mania, schizophrenia, or other psychoses
  • Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
  • Pregnancy or breast feeding
  • Impaired or uncorrected hearing

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Maryland Baltimore School of Nursing — Baltimore

Идентификаторы

NCT: NCT07680894 · HP-00119506

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗