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Набор скоро начнётся NCT07736534

Telehealth Specialty Concussion Treatment for Youth

Без фазы С лечением Concussion

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: Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery).
Кому может быть актуально
Состояния в реестре: Concussion. Базовые параметры: 8 лет — 17 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 →
Официальное название

Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery): A Pilot Study

Обзор

Specialty concussion care can help youth recover more quickly but many youth face barriers to accessing concussion specialists. A care delivery model whereby concussion specialists are available to co-manage injuries with primary care pediatricians via telehealth can close the gap that currently exists in delivering specialty care to more youth. The long-term objective and intended impact of this project is to disseminate a care delivery model and manualized behavioral health intervention that can be widely deployed to make specialty concussion care accessible to more youth and earlier following their head injury.

Подробное описание

Youth who receive specialty concussion care recover more quickly. Unfortunately, specialty concussion care is not accessible to all children and adolescents. Initial studies suggest that delivering specialty concussion care via telehealth is feasible and effective, however, available studies have been conducted in specialty clinics. As noted, there are barriers accessing specialty concussion clinics and furthermore youth with concussion most frequently initiate care with their primary care provider. The objective of this study is to pilot an innovative care delivery model whereby a concussion specialist provides telehealth-based consultations to co-manage concussions with primary care pediatricians. The care delivery model is a manualized intervention for the first four weeks following pediatric concussion, called Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery or SPEEDY Recovery. The intervention includes: 1) behavioral symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each youth based on their symptoms, 2) guidance to support school reintegration following concussion (e.g., study strategies, symptom management strategies for school, documentation for time-limited accommodations to support recovery), and 3) guidance to return to sports (if relevant). The aims of this project are to pilot the feasibility, acceptability, and credibility of the SPEEDY RECOVERY program as well as to determine potential implementation barriers and examine patient, caregiver, and pediatrician perceptions of the program. A pilot trial will recruit 10 pediatric patients with recent concussion (presenting to their primary care provider within 5 days of injury) from an urban, hospital-based pediatric primary care clinic that serves predominantly under-resourced youth and families and that does not have an affiliated concussion specialist. The intervention will be delivered via once weekly telehealth visits with a concussion specialist (neuropsychologist) until youth are recovered (youth and caregivers report resolution of concussion-related symptoms and return to normal state of health) or up to 4 weeks post injury (at which point recovery will be deemed prolonged and youth will be referred to appropriate rehabilitation services). Exit interviews will be conducted with youth and their caregivers at the final visit. Additionally, pediatricians in the practice will be surveyed at the end of the study regarding successes and opportunities for improving the program as well as reasons why they referred or did not refer patients. The youth, caregiver, and provider feedback will inform improvements and refinements to the design and implementation details to maximize the relevance and benefits of the program. The long-term objective is to disseminate a care delivery model and manualized behavioral health intervention that can be widely deployed to make specialty concussion care accessible to more youth and earlier following their head injury.

Вмешательства

  • Поведенческое Specialist and Pediatrician Co-Management for Early and Effective Concussion Care Delivery to Hasten Your Recovery (SPEEDY Recovery)
    The SPEEDY Recovery program is a novel, concussion-specialist telehealth consultation and co-management intervention for the first 4 weeks post injury. The program involves a concussion specialist (clinical neuropsychologist) meeting with a youth and caregivers once per week via telehealth to provide: 1) behavioral health symptom management strategies including recommendations for headaches, sleep difficulty, emotional health/stress reduction, and cognitive symptoms, individualized for each yout

Первичные конечные точки

  • SCAT6 Symptom Questionnaire [Срок оценки: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)]
  • ChildSCAT6 Symptom Questionnaire [Срок оценки: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)]
  • Credibility and Expectancy Questionnaire (CEQ) [Срок оценки: Final Study Visit (up to 4 weeks post injury)]
Вторичные конечные точки (5)
  • SCAT6 Cognitive Screening [Срок оценки: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)]
  • ChildSCAT6 Cognitive Screening [Срок оценки: Initial visit (within 5 days of injury) and Final Study Visit (up to 4 weeks post injury)]
  • GAD-7 [Срок оценки: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)]
  • PHQ-9 [Срок оценки: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)]
  • Concussion Learning Assessment & School Survey, 3rd Edition (CLASS-3) [Срок оценки: Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury)]

Критерии участия

Критерии включения

  • youth aged 8 to 17
  • At least one parent/caregiver present and willing to participate
  • English proficiency
  • access to an internet connected device,
  • within 5 days of injury

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
Лечение

Центры проведения

США · 1 центр
  • Hasbro Children's Hospital — Providence

Идентификаторы

NCT: NCT07736534 · 2526-316

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗