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临床试验/NCT05069948
NCT05069948已完成不适用

Delivery of Digital Cognitive Behavioural Therapy Following Concussion: HeadOn Feasibility Study

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Participant Compliance With HeadOn Program

研究概览

简要总结

Concussion is common and patients can go on to suffer with a constellation of symptoms which impacts their functional outcome and quality of life. Patient provision with information about their concussion and subsequent follow-up is highly variable. The investigators have developed HeadOn - a web application that delivers a CBT programme to patients following concussion. In this study, the investigators would like to examine the feasibility of digitally delivering a course of CBT to patients following concussion.

详细描述

The HeadOn study is a prospective feasibility study of patients presenting to the Emergency Department (ED). Potentially eligible patients will be contacted by a member of the research team and their consent will be sought for participation. Those not recruited at presentation to the ED will be contacted by telephone, text or email within two weeks of their concussion date to seek their participation in the study, again by a member of the research team. After consenting, the participant will be taken through the registration process for the HeadOn program. For patients who are contacted after discharge they will be taken through registration process over the telephone or if preferable will be able to return to the ED to go over the process.

At registration the participant will be invited to complete a series of patient reported measures including the Rivermead post-concussion questionnaire, Pittsburgh Sleep Quality Index, PHQ9 questionnaire and FAST alcohol questionnaire within the HeadOn program. Alongside this, a series of researcher-led anonymised data points will be collected in a separate specially designed database including demographics, date of concussion, neurological and imaging findings which will all be collected from the medical notes and imaging reports. The HeadOn program runs for five weeks following which the participant will be invited to complete the same set of outcome measures. Alongside this, all the participant will be contacted (via telephone, text or email) by a member of the research team at week 5 to complete a further five measurements: Glasgow Outcome Score Extended, mHealth App Usability questionnaire, time to return to work and a healthcare utility questionnaire. Interested participants will be invited back within two months of enrolling in the study for a more detailed qualitative interviews about HeadOn. The study will recruit for a period of 6-months or up to 100 participants.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 16 years and older (no upper age limit)
  • Presenting to the ED with a concussion
  • Concussion defined as a traumatically induced alteration of mental status (either defined as loss of consciousness and/or amnesia)
  • Patient is Glasgow Coma Scale score of 13-15 on initial presentation to the ED
  • Patient needs to be able to start using HeadOn within 14 days of their head injury

排除标准

  • Patients aged under 16 years old
  • Patients requiring surgical management of their cranial injury
  • Significant other associated injuries requiring hospitalisation (spinal injury, fractures, abdominal, cardiothoracic or vascular injuries)
  • Does not have capacity to give consent
  • Non-English speakers
  • Patient in police custody or in prison

结局指标

主要结局

Participant Compliance With HeadOn Program

时间窗: 5 weeks

Degree of engagement of study participants with the HeadOn program. This was defined as whether the participant entered data into the HeadOn functionality (including symptom diary, sleep time setting, alcohol tracker, exercise day setting, thought diary and goal setter)

次要结局

  • mHealth App Usability Questionnaire(5 weeks)
  • Rivermead Post-concussion Questionnaire(5 weeks)
  • PHQ9 Questionnaire(5 weeks)
  • Glasgow Outcome Score Extended(5 weeks)
  • Return to Work Rate(5 weeks)
  • Healthcare Resource Utilisation(5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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