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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeadOn intervention | Experimental | Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeadOn | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Compliance With HeadOn Program | 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) | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| mHealth App Usability Questionnaire | The mobile Health App Usability Questionnaire (MAUQ) is a validated questionnaire that examine participants' attitudes to an mHealth intervention. MAUQ quantifies respondents' perceptions of the usability of a mobile health app using a range from 1 to 7. A score of 7 indicates a high degree of usability. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimun Jamjoom, FRCS | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edinburgh Royal Infirmary | Edinburgh | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36724010 | Derived | d'Offay C, Ng XY, Alexander L, Grant A, Grahamslaw J, Pagliari C, Reed MJ, Carson A, Gillespie DC, Jamjoom AAB. A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study. JMIR Form Res. 2023 Feb 1;7:e43557. doi: 10.2196/43557. |
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Annonymised study data will be made available on Edinburgh University's DataShare service
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Data will be available for 5 years after completion of the study
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| ID | Title | Description |
|---|---|---|
| FG000 | HeadOn Intervention | Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HeadOn Intervention | Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Compliance With HeadOn Program | 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) | Posted | Count of Participants | Participants | 5 weeks |
|
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5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HeadOn Intervention | Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aimun Jamjoom | The University of Edinburgh and NHS Lothian | 0131 536 1000 | v1ajamjo@ed.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2021 | Mar 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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. It examines 16 post-concussion symptoms which are rates from 0 (no symptom) to 4 (severe symptom). This gives a range from 0 (o post-concussion symptoms) to 64 (severe post-concessional symptoms). | 5 weeks |
| PHQ9 Questionnaire | The Patient Health Questionnaire (PHQ)-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Range include 0 (no depression) to 27 (severe depression). | 5 weeks |
| Glasgow Outcome Score Extended | The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status. There are 8 categories that are denoted numerically as follows: Dead (1), Vegetative State (2), Lower Severe Disability (3), Upper Severe Disability (4), Lower Moderate Disability (5), Upper Moderate Disability (6), Lower Good Recovery (7), and Upper Good Recovery (8). | 5 weeks |
| Return to Work Rate | Patient self reported outcome measure. Participants were contacted by telephone at the completion of HeadOn (5 weeks from registration) and asked the following question 'Have you returned to work?'. The outcome was dichotomous and was either coded as 'yes' or 'no' based on participant response. The measure was then reported as a return to work rate which was the percentage of participants who reported they had returned to work at the completion of HeadOn. | 5 weeks |
| Healthcare Resource Utilisation | Patient Self reported outcome measure. At completion of the HeadOn program (5 weeks from registration), the participants were contacted by telephone and were asked 'Have you sought healthcare professional support due to your post-concussion symptoms since you started using HeadOn?'. The outcome was a dichotomous outcome and was either coded as 'yes' or 'no'. The definition of healthcare professional included: returning to the emergency department, seeing family doctor, a neuropsychologist, physiotherapist or sports medicine doctor). The outcome measure was reported as the percentage of respondents who sought healthcare professional input while using HeadOn. | 5 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | mHealth App Usability Questionnaire | The mobile Health App Usability Questionnaire (MAUQ) is a validated questionnaire that examine participants' attitudes to an mHealth intervention. MAUQ quantifies respondents' perceptions of the usability of a mobile health app using a range from 1 to 7. A score of 7 indicates a high degree of usability. | Only 29 (out of 50) participants responded to this questionnaire | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
|
|
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| 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. It examines 16 post-concussion symptoms which are rates from 0 (no symptom) to 4 (severe symptom). This gives a range from 0 (o post-concussion symptoms) to 64 (severe post-concessional symptoms). | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
|
| Secondary | PHQ9 Questionnaire | The Patient Health Questionnaire (PHQ)-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Range include 0 (no depression) to 27 (severe depression). | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
|
| Secondary | Glasgow Outcome Score Extended | The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status. There are 8 categories that are denoted numerically as follows: Dead (1), Vegetative State (2), Lower Severe Disability (3), Upper Severe Disability (4), Lower Moderate Disability (5), Upper Moderate Disability (6), Lower Good Recovery (7), and Upper Good Recovery (8). | Posted | Median | Full Range | Score on a scale | 5 weeks |
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|
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| Secondary | Return to Work Rate | Patient self reported outcome measure. Participants were contacted by telephone at the completion of HeadOn (5 weeks from registration) and asked the following question 'Have you returned to work?'. The outcome was dichotomous and was either coded as 'yes' or 'no' based on participant response. The measure was then reported as a return to work rate which was the percentage of participants who reported they had returned to work at the completion of HeadOn. | 25 participants responded to this outcome measure | Posted | Count of Participants | Participants | 5 weeks |
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|
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| Secondary | Healthcare Resource Utilisation | Patient Self reported outcome measure. At completion of the HeadOn program (5 weeks from registration), the participants were contacted by telephone and were asked 'Have you sought healthcare professional support due to your post-concussion symptoms since you started using HeadOn?'. The outcome was a dichotomous outcome and was either coded as 'yes' or 'no'. The definition of healthcare professional included: returning to the emergency department, seeing family doctor, a neuropsychologist, physiotherapist or sports medicine doctor). The outcome measure was reported as the percentage of respondents who sought healthcare professional input while using HeadOn. | 29 participants responded to this outcome measure | Posted | Count of Participants | Participants | 5 weeks |
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| 0 |
| 50 |
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| 50 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |