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Clinical Trial Summary

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. We have developed HeadOn - a web application that delivers a CBT programme to patients following concussion. In this study, we would like to examine the feasibility of digitally delivering a course of CBT to patients following concussion.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05069948
Study type Interventional
Source University of Edinburgh
Contact Aimun Jamjoom, FRCS
Phone 0131 242 3867
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 18, 2021
Completion date May 5, 2022

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