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Набор по приглашению NCT07737912

SpinePal Open Pilot

Без фазы С лечением Spine Surgery

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: SpinePal.
Кому может быть актуально
Состояния в реестре: Spine Surgery. 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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Официальное название

User-Centered Development of an App-Based Cognitive-Behavioral Intervention to Reduce Persistent Opioid Use and Opioid Related Problems Following Spine Surgery

Обзор

SpinePal is a self-guided digital intervention developed for patients undergoing spine surgery. The goal of this study is to learn if SpinePal is acceptable to people undergoing spine surgery. The main questions the investigators aim to answer are: * Is the SpinePal platform considered usable and acceptable by people undergoing spine surgery? * Is the SpinePal intervention feasible among people undergoing spine surgery? Participants will: * Take a screening questionnaire * Engage with SpinePal for about 2 weeks before surgery and 4 weeks after surgery * Wear a smartwatch * Complete questionnaires about 4 weeks after surgery * Complete a brief virtual interview to share feedback with the study team

Подробное описание

SpinePal will be piloted in a sample of N = 10 patients who are scheduled to undergo lumbar or cervical spine surgery. A pre-surgery enrollment visit will occur via Zoom at least 2 weeks prior to the patient's surgery. Prior to the visit, the participant will complete screening and baseline measures. The research coordinator will then provide instructions for accessing SpinePal, including a unique user ID and password assigned to the participant. During the enrollment visit, participants will also be provided with instructions for completing physiological monitoring via a wrist-worn Garmin Vivosmart 5. The Garmin will be used to passively collect data on physiological arousal (i.e., heart rate variability), physical activity, and sleep throughout the open pilot. To enable collecting this Garmin data, the research coordinator will also assist participants with downloading and logging into a Labfront account on their smartphone.

Participants will be instructed to use SpinePal for 2-4 weeks leading up to surgery, and for at least 1 month after surgery. Participants will receive daily reminders via push notifications delivered to their smartphone. SpinePal will collect background app usage data to assess adherence and track usage of specific tools.

At 1-month postoperative, participants will receive a link to a REDCap survey including the System Usability Scale (SUS) and Client Satisfaction Questionnaire (CSQ-8), which will serve as the primary outcomes in combination with adherence based on app meta-data. Participants will also repeat surveys conducted preoperatively. The participant will then complete a 30-minute semi-structured exit interview with the research coordinator to gather additional feedback on the intervention framework, platform, content, and procedures.

Вмешательства

  • Устройство SpinePal
    SpinePal is a web-based app designed to support patients undergoing spine surgery. The app includes tailored pain education, cognitive-behavioral skills, mindfulness and relaxation activities, and guided imagery exercises. SpinePal was developed through an iterative refinement process with patients who previously underwent surgery and experienced persistent pain, impairment, and opioid use.

Первичные конечные точки

  • Usability [Срок оценки: Enrollment to the end of treatment at 1 month post-surgery]
  • Acceptability [Срок оценки: Enrollment to the end of treatment at 1 month post-surgery]
  • Feasibility [Срок оценки: Enrollment to 1 month post-surgery]

Критерии участия

Критерии включения

  • 18 years or older
  • English-speaking
  • Able and willing to provide informed consent
  • Scheduled for lumbar or cervical fusion surgery at least 2 weeks from the date of enrollment
  • Owns a smartphone with reliable internet and/or data access
  • Willing to engage with SpinePal and physiological monitoring via wrist-worn Garmin

Критерии исключения

  • Undergoing surgery for infection, malignancy, or trauma
  • Undergoing isolated thoracic fusion
  • Undergoing another major surgery within 3 months
  • Active suicidal ideation and/or severe mental illness (e.g., psychosis)

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
Оценка устройства

Центры проведения

США · 1 центр
  • Dartmouth Geisel School of Medicine — Lebanon

Идентификаторы

NCT: NCT07737912 · STUDY00033396 · 5P30DA029926-15

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗