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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05069948
Other study ID # 2021/0151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date April 22, 2022

Study information

Verified date November 2021
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 22, 2022
Est. primary completion date March 11, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HeadOn
HeadOn is a web application which takes the participant through a 5-stage CBT programme including: (i) understanding post-concussion symptoms; (ii) sleep after a concussion; (iii) lifestyle habits and exercise; (iv) managing negative thought patterns and (v) returning to baseline. The programme is delivered through a combination of weekly tasks (such as completing symptom diary, setting exercise goals and setting up a sleep time routine), audio/video media and reading material.

Locations

Country Name City State
United Kingdom Edinburgh Royal Infirmary Edinburgh

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant compliance with HeadOn program Data inputted into the digital CBT program will be used as surrogate marker of participant compliance. During each stage of the program participants are required to input data as part of the CBT tasks. Participants will be divided into the following three groups: Fully compliant: participants who input data into the program during all five stages; Partially compliant: participants who input data but not during all five stages; Non-compliant: participants who do not enter any data into the program On completion of 5 week HeadOn program
Primary mHealth App Usability Questionnaire Validated questionnaire that examine participants' attitudes to an mHealth intervention On completion of 5 week HeadOn program
Secondary Rivermead post-concussion questionnaire The Rivermead Post-Concussion Symptom Questionnaire (RPQ) is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury On completion of 5 week HeadOn program
Secondary PHQ9 questionnaire The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ On completion of 5 week HeadOn program
Secondary Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and disturbance retrospectively over a 1-month period using self-reported symptoms and sleep. On completion of 5 week HeadOn program
Secondary Glasgow Outcome Score Extended The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status On completion of 5 week HeadOn program
Secondary Time to return to work Questions regarding patients return to work and timeframe to achieve this On completion of 5 week HeadOn program
Secondary Healthcare utilisation Questions on healthcare resource utilisation while using HeadOn program On completion of 5 week HeadOn program
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