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Digital health interventions such as the Triumf game have great potential as health improving scalable tools by contributing to the effectiveness, accessibility and personalisation of healthcare delivery. However, digital health interventions (as any other intervention) need to be evaluated using proper research methodology in order to prove effectiveness or at least safety.
Usually these studies are done in a way that a feasibility or a pilot study is conducted first to evaluate the procedural feasibility and individual response to the intervention. If successful, these studies are followed by randomized controlled trials (RCT) to compare the effect of the intervention with the control group (usually treatment as usual). Here, we are giving an overview of our Step 1 Study that was conducted among school-aged pediatric cancer patients with less than a year from the diagnosis.
The multi-site clinical study was conducted in two major public hospitals in Estonia - Tartu University Hospital and Tallinn Children’s Hospital. We invited 15 patients to participate, 10 agreed and 9 completed (4 girls and 5 boys) the 60-day digital health intervention study. There are around 35 new pediatric cancer cases among children under the age of 18 every year in Estonia (Paapsi et al., 2017). Our study was completed by 26% of all pediatric cancer patients at a given year, making our sample representative of the pediatric cancer population. However, the participants were between the age of 7 and 12, which needs to be taken into account when interpreting the results. For example, we already knew that the perception of the narrative of the game could be age dependent as we evaluated this prior to the clinical study among kids with different cultural backgrounds. In our Triumf game, the protector of the Triumfland city (the player) helps the Doctor to put up a fight against the Disease Monster. Kids (who were not part of current study) in general gave a very positive feedback on the narrative - rating of 8.2/10 is very high considering the big differences in the preferences of the age group. However, we saw that kids below age of 10 gave higher scores than older ones, although even a 16-year-old found the narrative to be engaging.
Before proceeding with the Step 1 Study results, you might ask why we conducted the study in Estonia if our HQ is in Helsinki. In Finland we are the proud members of the Business Finland funded Icory consortium that involves various players in the industry and is aimed to digitalize and gamify patient journey. This means that our solution is also going to be part of the pilot study of this co-creation ecosystem that takes place in the Helsinki University Central Hospital's new Children’s Hospital. This in turn means that in Finland we are progressing together with the consortium while exploring other research collaboration independently elsewhere. For example we are also starting a pilot in Denmark with Steno Diabetes Center through EU funded ProVaHealth project. But now the most important part of the post - the sneak peek to the research findings!
We are now in the process of publishing the findings but until then we would like to share some insights from the study. In general, we had two main research questions we wanted to address with the study: 1. How is the game perceived (from the patient perspective - the acceptability of the content) and procedural issues (from the care team perspective - the likelihood of the reach and uptake of the intervention); 2. Does the game have a potential effect as a digital health intervention to reduce the mental burden of chronic illness - the individual response to the intervention measured with external self-report questionnaires filled in both by the kid and by the parent.
How was the game perceived?
The following section is based on 12 questions that were asked during a qualitative interview that was conducted by a trained psychologist in the native language of the study participant (either in Estonian or in Russian). We left out the questions that were hard to answer for the kids in our age group (e.g. was the game motivating or benefited their mental health or did the game have similar characters to the participants). We divided the 12 remaining questions into the following three categories:
Usability and fun component (including the following questions: (1) was the game easy to use; (2) were the instructions clear; (3) was the game fun to use; (4) did you like the visuals; (5) did you like the activities; (6) did you like the characters). This component showed that 88% found the game to be easy to use and fun.
Usefulness and content section (including the following questions: (1) did you learn something; (2) was the content useful; (3) was the info trustworthy; (4) did the game provide distraction from treatment). This component showed that 87% found the content useful and trustworthy.
Recommendation and continuation (including the following questions: (1) would you recommend the game to a friend; (2) would you like to continue playing the game; (3) would you play again). This component showed that 82% would continue playing and would recommend to a friend.
When combining those three subscales, we found that the total acceptability percentage was 86%. It is important to bring out that 100% answered that the game was easy to use and that the content and information was useful and trustworthy. Furthermore, 100% would recommend the game to a friend.
Was the game effective as a digital health intervention?
The following section is based on the external self-report questionnaires that were filled in both by the kid and by the parent. The main findings are based on the Mental Health and Health Related Quality of Life Questionnaire for children and young people and their parents. By comparing pre-study and post-study mean scores (the averages of the combined scores of the kid and the parent), we found improvements in mental health and health related quality of life. Mental health improved on average 2.3 points and health related quality of life on average 2.1 points.
As discussed earlier, important next step for us is a RCT that will be conducted among patients with various chronic conditions including diabetes and asthma. General guidelines propose that RCTs should be completed only if: a) the intervention and its delivery package are stable; b) these can be implemented with high fidelity and c) there is a reasonable likelihood that the overall benefits will be clinically meaningful (improved outcomes or equivalent outcomes at less cost) (Murray et al., 2016). Based on our Step 1 Study, we are ready for Step 2! It’s also great to announce that our CEO is about to start her post-doc at Triumf Health, this kind of research funding (Mobilitas Pluss from Estonian Research Council) was given to a startup for the first time ever! It means that we are now in the process of writing yet another ethical committee application to be able to start our multi-site RCT while publishing the findings from this study.