A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study

Background Concussion is a common condition that can lead to a constellation of symptoms that affect quality of life, social integration, and return to work. There are several evidence-based behavioral and psychological interventions that have been found to improve postconcussion symptom burden. However, these are not routinely delivered, and individuals receive limited support during their concussion recovery. Objective This study aimed to develop and test the feasibility of a digital health intervention using a systematic evidence-, theory-, and person-based approach. Methods This was a mixed methodology study involving a scoping review (n=21), behavioral analysis, and logic model to inform the intervention design and content. During development, the intervention was optimized with feedback from individuals who had experienced concussions (n=12) and health care professionals (n=11). The intervention was then offered to patients presenting to the emergency department with a concussion (n=50). Participants used the intervention freely and input symptom data as part of the program. A number of outcome measures were obtained, including participant engagement with the intervention, postconcussion symptom burden, and attitudes toward the intervention. A selection of participants (n=15) took part in in-depth qualitative interviews to understand their attitudes toward the intervention and how to improve it. Results Engagement with the intervention functionality was 90% (45/50) for the symptom diary, 62% (31/50) for sleep time setting, 56% (28/50) for the alcohol tracker, 48% (24/50) for exercise day setting, 34% (17/50) for the thought diary, and 32% (16/50) for the goal setter. Metrics indicated high levels of early engagement that trailed off throughout the course of the intervention, with an average daily completion rate of the symptom diary of 28.23% (494/1750). A quarter of the study participants (13/50, 26%) were classified as high engagers who interacted with all the functionalities within the intervention. Quantitative and qualitative feedback indicated a high level of usability and positive perception of the intervention. Daily symptom diaries (n=494) demonstrated a wide variation in individual participant symptom burden but a decline in average burden over time. For participants with Rivermead scores on completion of HeadOn, there was a strong positive correlation (r=0.86; P<.001) between their average daily HeadOn symptom diary score and their end-of-program Rivermead score. Insights from the interviews were then fed back into development to optimize the intervention and facilitate engagement. Conclusions Using this systematic approach, we developed a digital health intervention for individuals who have experienced a concussion that is designed to facilitate positive behavior change. Symptom data input as part of the intervention provided insights into postconcussion symptom burden and recovery trajectories. Trial Registration ClinicalTrials.gov NCT05069948; https://clinicaltrials.gov/ct2/show/NCT05069948

"Try to do it every day, well of course with the concussion as well I've sort of been quite forgetful, that's been part of it as well." "Well, when I remember, I try to do it every night, try to set myself some time to remember every night, but sometimes forget, I generally try. I would say 5 times a week I'm managing.' Increased number of emails and notifications to support memory and enhance engagement Many participants complained of the sensitivity of the alcohol tracker. This meant that they accidently added units they did not consume. The feature did not have a minus button so participants were unable to correct the mistake. Participants reported being frustrated and annoyed by this.
"Yeah, and with the alcohol tracker, um, it I was expecting a number to come up with the amount of alcohol I was supposed to have consumed today, so a wheel that you would hit, and a number would of come up with the number you had hit, drank that day. And I kept pressing it, looking for it, and it come up that I'd drunk 25 units of alcohol and I'd actually drunk none." Addition of a minus button to the alcohol tracker.
Participants that built a routine around logging into the intervention, for example at the same time every day or with other medication were more successful at engaging with the intervention every day.
"I usually do it in the afternoon, because what I found, some of the times I missed it, it was the evening, and then we sat down to watch TV and I forgot about it. So mid-to late afternoon, is the easiest time to do it for me." "Really was as part of a routine. I had it on my laptop and would log into my laptop once a day and Provide information about the benefits of setting a routine.
as part of that I would checking my emails, doing other things, I would do it as part of that process." Participants that set their own reminders to log-in were more successful at logging in and engaging with the intervention "Every single day or every second day, the longest period I went without was like 3 days. But I set reminders on my phone now to make sure I do it that day." Provide information about the benefits of setting reminders and instruction on how to set a reminder.
Participants who saved the intervention to their device home screen, found logging in easier and were more successful at engaging regularly. Participants who did not found it difficult to remember how to log-in and some had a lengthier process for logging in, for example searching in the email for the link.
"I know it isn't an app but it was saved to my home screen, so I was able to see it there and I was able to remember to go into it." Include an automated add to home-screen button and information on the benefits of saving the intervention to the device home-screen.
Many participants stated that they were unable to remember the incident which they got their injury. They found the thought monitor activity challenging because of this. Whilst the thought monitor was designed for reflection on general concussion and recovery, many participants understood it to focus on the incident.
"think it was the most recent one, you had to like write more, it was more than multiple choice. You had to write out a wee thing about how you were feeling and it was just like the same question, but I couldn't really write about what had happened because it's just what people had told me. So I felt a bit useless. I couldn't fill it out that well." Review and edit the language in the thought monitor.
Difficulty with registering and using intervention in first few days after injury, due to high symptom burden. Capacity to use screens and focus reduced. Needed social support to register and use app "there are people like me who are kind of struggling with computer screens and staying of computer and social media in the immediate period after their head injury, and you know that is a little bit of an issue." Streamline the registration process to make it easier to do. Sign post users to the audio clips to allow alternative means of consuming HeadOn information without the need to look at a screen "Accept that in the first few days I couldn't look at a screen and had difficulty reading and wasn't a very easy format to engage with… so it would have been better if they sent it to a partner and they could of said 'do you want to sign up for this?' You know they know my name. I think it would have been more effective to send it to someone."

Database
Search strategy Hits MEDLINE(Ovid) and Cochrane Library (Wiley)
2) (mild traumatic brain injury or mTBI or mild head injury).ti,ab. 3) brain concussion/ 4) 1 or 2 or 3 5) self-management/ or self care/ 6) rehabilitation/ or physical therapy/ or exercise/ or movement therapy/ or "rest" 7) health education/ or health knowledge/ or health literacy/ or health promotion/ or psychoeducation/ 8) psychotherapy/ or psychotherapeutic counselling/ or psychotherapeutic Provide an explicit statement of the questions and objectives being addressed with reference to their key elements (e.g., population or participants, concepts, and context) or other relevant key elements used to conceptualize the review questions and/or objectives.
Pages 4 and 6

Protocol and registration 5
Indicate whether a review protocol exists; state if and where it can be accessed (e.g., a Web address); and if available, provide registration information, including the registration number.
As sub-study protocol not registered Eligibility criteria 6 Specify characteristics of the sources of evidence used as eligibility criteria (e.g., years considered, language, and publication status), and provide a rationale.

Page 6
Information sources* 7 Describe all information sources in the search (e.g., databases with dates of coverage and contact with authors to identify additional sources), as well as the date the most recent search was executed. State the process for selecting sources of evidence (i.e., screening and eligibility) included in the scoping review.

Page 6
Data charting process ‡ 10 Describe the methods of charting data from the included sources of evidence (e.g., calibrated forms or forms that have been tested by the team before their use, and whether data charting was done independently or in duplicate) and any processes for obtaining and confirming data from investigators. na

Data items 11
List and define all variables for which data were sought and any assumptions and simplifications made.

Selection of sources of evidence 14
Give numbers of sources of evidence screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally using a flow diagram. For each source of evidence, present characteristics for which data were charted and provide the citations. Were major themes clearly presented in the findings? Table 5 32. Clarity of minor themes Is there a description of diverse cases or discussion of minor themes?