Digital Gaming for Persons With Traumatic Brain Injury
Condition: Brain Injuries; Traumatic Brain Injury; TBI (Traumatic Brain Injury); Injury, Brain, Traumatic; Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this feasibility study is to determine whether digital games are effective and
      acceptable in the treatment for patients with traumatic brain injury.
    

Detailed description: 
      This is a feasibility study using a pragmatic, randomized controlled trial with three arms.

      The study will be conducted within the Turku University Hospital, Division of Clinical
      Neurosciences (Operational Division of Clinical Neurosciences, Department of Rehabilitation
      and Brain Trauma in collaboration with former neurology outpatient clinic and rehabilitation
      units of the university hospital). The Division is specialized in demanding neurological and
      psychiatric inpatient rehabilitation, inter-professional neurological education,
      rehabilitative examinations, and the inpatient and outpatient care of traumatic brain
      injuries. In each year, about 500 patients are admitted in the Division services units.

      The recruitment will be focused on patients who have been discharged from the Turku
      University Hospital, Division of Clinical Neurosciences at least one year before the starting
      day of the recruitment process. Based on the previous literature, using games in longer
      interventions will be facilitated if training is provided in the persons' home, due to easier
      access and reduced impact on school or work activities (Burbea et al. 2011).

      The randomisation and patient allocation will be fully centralized; we will use a central
      randomization service by the University of Turku. The randomization will be targeted on
      patients who have been hospitalized in Turku University Hospital and who are registered in
      the Hospital electronic medical records. The study will be individually randomized.
      Allocation will be computer generated. The participants will be randomly assigned in numbers
      via computerized assignment developed by the independent Trial Statistician and implemented
      by the Research Assistant who are trained for patient randomization and data collection.

      Participants and the investigators enrolling the patient recruitment and randomization will
      not foresee assignment. Allocation will be masked to participants in two intervention groups;
      participants will be aware about the gaming intervention, but not which one is the
      experimental and which is the comparator. Investigators will not be masked to group
      allocation, while data analysts (outcome assessor) will be kept blinded to the allocation. As
      far as we are aware, there will be no contact between participants in different groups;
      participants are living in wide geographic area in the catchment area of Southwest Hospital
      District.

      To capture a representative sample of patients, the Turku University Hospital electronic
      medical records will be used. The medical records will be accessed by the authority of the
      Chief medical doctor of the Hospital and screened by the Research Assistant. All patients
      with TBI diagnosis will be screened to find out patients who fulfill the eligibility criteria
      for the study participation.

      Those patients who fulfill the inclusion criteria will be contacted with the telephone call
      by the Research Assistant. A preliminary description of the study will be offered and the
      inclusion criteria for the study will be described to them. The participants are able to
      answer whether they fulfill the specific inclusion criteria and their preliminary interest
      toward the study will be asked.

      Those who fulfill the inclusion criteria and are willing to participate in the study, will
      receive postal information of the study, two items of informed consent forms, questionnaires
      to be filled at home (baseline data), and a short description of eight entertainment games to
      be used (if allocated into the control group). Further, possible participants are aware that
      after 1-2 weeks they will receive another call from the Research Assistant. This will ensure
      that possible participants have enough time to read all material, ask questions, and make
      their decision whether to participate in the study or not (and what type of game they would
      like to play if allocated into the control group).

      During the second telephone call, those who are willing to participate in the study will get
      information about practical arrangement of the study and the place of the data collection.
      They are also informed that all travel costs will be covered and that the time for
      face-to-face meeting may take totally 1-1.5 hours. Participants are also aware that they are
      free to withdraw from the study at any time. At the end of the telephone call, a specific
      time for the face-to-face meeting with the Research Assistant will be arranged.

      During the face-to-face meeting at the University of Turku, it will be ensured that
      participants will fulfill the inclusion criteria. If a patient fulfills the criteria, a
      signed written informed consent will be returned/obtained. Should a person consent, their
      pre-filled baseline data will be gathered. The Research Assistant will receive this
      information by email, text message or telephone call. Cognitive measurement will be also
      conducted by the psychologist. After that eligible patients will be informed to Trial Manager
      who allocates patients in one of the three arms of the trial based on computer generated
      randomization list (intervention vs. control group vs. "As-usual"). Recruitment will continue
      until the required data has been received.

      Criteria for the feasibility:

        -  Willingness to participate 80 % (refusal rate 20 %)

        -  We will expect that more than 75% of the prescheduled measurements would be performed
           (adherence)

        -  Less than 25 % of participants would drop out due to any reason (adherence)

        -  The acceptability of the game use would be at least 95% (in intervention and control
           groups) (adherence)

        -  Usability evaluation for the gaming system would be at least 80% (1 item; dichotomous
           scale yes/no) (usability)

        -  More than 80% will be satisfied with the games (1 item; dichotomous scale, yes/no)
           (satisfaction)

        -  We will expect that 60% are willing to use the games later as part of their recovery
           process (use in the future)

      The calculations for sample size needed in each group are preliminary estimations to guide
      our data collection. This has been performed with two outcome variables used in this study:
      a) TMT version A (Lezak et al. 2004) and b) depression (PHQ-9, Kroenke et al. 2001).

        1. Let's assume that the average level of the TMT version A score is about 71 and the mean
           change in the scores during the follow-up is 30. Let's assume that the standard
           deviation of the TMT scores is 53. This difference could be expected to be significant
           (with power 85% on significant level 0.05) if the sample size in each group is 30
           subjects.

        2. Let's assume that the average level of the PHQ-9 score is about 10 and the mean change
           in the scores during the follow-up is 3. Let's assume that the standard deviation of
           PHQ-9 scores is 5. This difference could be expected to be significant (with power 85%
           on significant level 0.05) if the sample size in each group is 27 subjects. Conclusion:
           Based on these preliminary power calculations, sample size to be used in this study
           (30/a group) will be quite sufficient to detect significant within-group changes between
           baseline and follow-up in the outcome measures. However, this means that the attrition
           rate of the study should be near 0 %. The outcomes of this feasibility study can be used
           as a guide to estimate a sample size for our future study.

      The cumulative monitoring data during the 8-week period regarding gaming for the total number
      of received parameters (frequency, timing, time) will be calculated. Information available
      for each patient will also be calculated (participation/refusal rate, measurement instrument
      filled, drop-outs, acceptability, usability, satisfaction, willingness) and compared to the
      highest possible representative numbers (100 % of participation rate; measurement instrument
      filled, drop-out rate 0 %, acceptability 100 %, usability 100%, satisfaction 100%,
      willingness to use games in the future 100 %).

      For the secondary outcomes, all the participants will be analysed at the baseline, after 8
      weeks when the intervention has been finalised, and 2 months, on all the scales as described
      earlier. Paired t-tests or Chi square tests will be performed to detect significant
      differences before and following treatment in one group. Significant differences between
      groups will be evaluated applying the unpaired Student's t-test using the conventional 95 %
      level of confidence. In all tests, p-values <0.05 were considered significant.
    

Intervention name(s): The rehabilitation gaming; The entertaining gaming
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The web-based cognitive training platform CogniFit includes about 33 mini games designed with the purpose of improving the user's cognitive abilities as brain exercises. For the purpose of the research, a selection of CogniFit mini games will be included in the intervention. The mini game tasks will be adapted to players' skills getting more difficult as the players progress. The game tasks are targeting different cognitive abilities such as memory, visual-spatial ability, attention, tracking and fast decision making.; The gameplay will consist of these main elements: 1) the player will be playing the main character of the game, 2) the character will be presented for the player from an isometric perspective, 3) the player will control the character by navigating in partly open-ended 3D environments in which the player must decide a direction and move towards it by avoiding obstacles; 4) the player will engage with real-time action events and act quickly by making strategic and tactical decisions; 5) the player must memorize locations, characters, dialogue and tasks; as well as 6) track, follow or aim at several objects simultaneously. Gaming requires also patience as participants can only make progress in games by trial and error.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Brain Injuries; Traumatic Brain Injury; Video Games