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临床试验/NCT07736534
NCT07736534尚未招募不适用

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

University of Rhode Island1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
SCAT6 Symptom Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

SCAT6 Symptom Questionnaire

时间窗: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)

The SCAT6 Symptom Evaluation(for youth 13 and older) is a self-report measure of the presence and severity of 22 symptoms associated with concussion. Scores can range from 0 to 132. Higher scores represent worse symptom severity.

ChildSCAT6 Symptom Questionnaire

时间窗: Initial visit (within 5 days of injury), once per week through study completion (up to 4 weeks post injury)

The ChildSCAT6 Symptom Evaluation (for children ages 8 to 12) is a self-report measure of the presence and severity of 21 symptoms associated with concussion. Scores can range from 0 to 63. Higher scores represent worse symptom severity.

Credibility and Expectancy Questionnaire (CEQ)

时间窗: Final Study Visit (up to 4 weeks post injury)

The Credibility and Expectancy Questionnaire (CEQ) assesses how believable, convincing, and logical patients perceive the treatment to be. Scores can range from 6 to 54. Higher score represent greater confidence and higher optimism in the treatment.

次要结局

  • SCAT6 Cognitive Screening(Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury))
  • ChildSCAT6 Cognitive Screening(Initial visit (within 5 days of injury) and Final Study Visit (up to 4 weeks post injury))
  • GAD-7(Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury))
  • PHQ-9(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)(Initial Visit (within 5 days of injury) and Final Visit (up to 4 weeks post injury))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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