The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients
Condition: Diabetic Patients, Gamification, Diabetic Education
Study type: Interventional

Summary: 
      Background: The prevalence of DM is increasing across both Asian and Western countries, in
      proportion to the rising aging population. Type 2 diabetic patients are the high-risk group
      to experience diabetes-related complications that can lead to depression, poor quality of
      life and even death. In the current face-to-face diabetes counseling, the patients presented
      with weak comprehension of diabetes knowledge. There is a gap between application of
      knowledge and self-efficacy behaviors. With the increased patient acuity in the recent years,
      it has contributed to the shortage of diabetes nurse educators to meet the demands or needs
      in the outpatient endocrine clinic. Often, the patients have to wait longer for their turn
      for diabetes education, which can result in a delay in diabetes self-management. The use of
      mobile health technologies had demonstrated a positive impact on diabetes-related outcomes
      and better self-efficacy behaviors, all of which are crucial in diabetes management.

      Aims: This study is to evaluate the effectiveness of Gamification Diabetes Education Program
      (GDEP) on HbA1c values, self-efficacy, sense of coherence and quality of life among the
      poorly controlled 2 diabetic patients.

      Methods: This study adopted a randomized control trial design. Based on Cohen's power
      analysis, one hundred and forty-eight participants will be recruited through simple random
      sampling. The recruitment process includes block randomization and allocation concealment.
      Participants will either be randomized into intervention (GDEP) group or control (current
      practice) group. The self-efficacy instrument, sense of coherence scale (SOC-13), world
      health organisation quality of life scale- brief (WHOQoL-BREF) and HbA1c values assessed the
      outcomes at the same time points: point of enrollment (pre) and two post-time points at
      12-week and 24-week.

      The significance of study: GDEP would bring about awareness on diabetes management and
      contribute to existing diabetes literature. It addresses the clinical significance of
      enhancing diabetes knowledge and motivation in self-efficacy behaviors. Hence, GDEP has the
      potential to close the gap between application of knowledge to self-efficacy behaviors, which
      in turn would result in better self-efficacy, sense of coherence and quality of life. All of
      these could reduce their HbA1c values and the global health care expenditure spent on
      managing diabetes mellitus alone. The development of GDEP is a value-added and
      innovative-driven packaging to close the gap and address the limitation in the current
      literature. It serves to transform workforce and redesign patient education process for type
      2 diabetic patients.
    

Detailed description: 
      The prevalence of Diabetes Mellitus (DM) is increasing internationally, corresponding with
      the rising aging population. Nearly half of the population was unaware that they have
      diabetes and the number is portended to reach 439 million worldwide by the year 2030. This
      global phenomenon draws the attention on the enormous health care expenditure spent on
      managing DM alone. The financial burden of diagnosed diabetes was 2.3 times higher than the
      absence of it, reflecting as one of the barriers in engaging diabetes patients and promoting
      self-efficacy. Type 2 diabetes patients, also known as non-insulin dependent diabetes, are
      the high-risk population to experience a diabetes-related complication, such as, end-stage
      renal failure (ESRF), stroke, cardiovascular disease and amputation of the limbs, all of
      which can lead to poor quality of life (QoL), depression and even death.

      Local statistics demonstrated an increase of 25.6% (2013 to 2015) of diabetic patients in an
      outpatient endocrinology clinic and ten percent hospital readmission rate of patients due to
      poor compliance and diabetes-related health issues. A retrospective study done locally in the
      primary health care polyclinics had shown an incline percentage of attendances with DM, from
      8.8% to 9.8% over the past five years (2011 to 2015), reflecting an increase of 8155 diabetic
      patients. Their average age group is 40 years old. According to American Diabetes Association
      (ADA, 2014), glycosylated hemoglobin A1c (HbA1c) value has been recognized as the standard
      measurement in diagnosing and treating DM and, the value of ≤7% was correlated with a
      reduction in diabetes complications. Each 1% of the reduction in HbA1c values over ten years
      is equivalent to 21% of the reduced risk of diabetes-related outcomes and death, including
      14% of the reduced risk for myocardial infarcts and 37% for microvascular complication
      (p<0.0001). Effective diabetes management or self-efficacy appears strongly related to
      healthy lifestyle modification and behavioral change, such as medication adherence,
      compliance to treatment-regime and exercising.

      In comparison, poor access to quality care, stress, and obesity has a detrimental effect on
      HbA1c values and increased the risk for diabetes-related complication as mentioned. Poor
      clinical outcomes consists of HbA1c >7.0%, systolic blood pressure > 130mmHg, body mass index
      (BMI) of ≥ 25, abnormal low-density lipoprotein (LDL) and high-density lipoprotein (HDL)
      measurement. Poor diabetes outcomes are related to depressive symptoms, anxiety, low
      self-efficacy, poor self-esteem, eating disorders and diabetes-related stress, including
      osteoporosis among the Chinese diabetes patients. Hence, diabetes patient education is an
      important cornerstone in self-management, self-efficacy, and long-term behavior change.

      Patient education is defined as a process of providing skills and knowledge, including giving
      advice and alternatives for lifestyle modification in diabetes management and glycemic
      control. Health education aimed at preventing diabetes-related complications and can lead to
      improved health literacy that supports greater empowerment in health decision-making and
      outcomes. There is no consistency of teaching contents in diabetes educational program. It
      could be due to that the program was led by a different healthcare professional, such as
      pharmacist, dietician or nutritionist, diabetes nurse educator and or psychologist.

      To some extent, the benefits of these diabetes education programs had shown improvement in
      self-management and glycemic control, including a reduction in depression, and enhancing
      self-efficacy behaviors and better quality of life. However, all these require an ongoing
      positive reinforcement in order to achieve a successful long-term intervention and good
      glycemic control. An effective diabetic patient education would mean success in diabetic
      self-management, which is associated with better metabolic control, lower costs of therapy
      through complication prevention, lower mortality rate, reduced readmission rates, improve QoL
      and, better self-efficacy and health behaviors.

      The current diabetic patient education in many hospitals locally, be it private or government
      sectors still use the traditional teaching method; the face-to-face approach. Primarily and
      tertiary health care sectors, like polyclinics and outpatient endocrinology clinics, are also
      using face-to-face approach. There are various health care professionals, such as doctors,
      nurses, diabetic nurse educator (DNE), dieticians and podiatrists who conduct diabetic
      education. Face-to-face interactions require intensive manpower, as health care professionals
      need to engage the patients within a stipulated time period. During these sessions, the DNEs
      needs to achieve the educational goals, such as impacting knowledge, assessing attitudes and
      encouraging self-efficacy towards managing their own disease. Each DNE takes an average of 45
      minutes in counseling each patient. At times, such educational goals can only be achieved
      over several scheduled visits, in view of the increasing patient numbers and acuity, and it
      may not be practical or feasible to achieve the long-term goal with one-time consultation. On
      the other hand, group based education had demonstrated better health outcomes in HbA1c
      values, diabetes knowledge, feeling of empowerment and reduced fatigue level although North
      and Palmer (2015) reported no significant difference (p<0.001) in HbA1c values between
      individual and group-based diabetes education. Nevertheless, the face-to-face advice remains
      an important influence on behavioral outcomes through motivation and counseling, and likely
      to constitute knowledge exchange through diabetes education. This social interaction enhances
      the quality of life (QoL) and promotes critical reflection upon why and how certain
      activities occur.

      A study conducted in Germany reported that elevated HbA1C value of ≥7% was associated with
      risk of cognitive-decline and dementia among the diabetes patients. Achieving good HbA1c
      level can delay the onset of microvascular complication (Venkataraman et al., 2013). Diabetes
      patient education can improve HbA1C values, be it at the most statistically significant at
      the third month (p=0.02). The other two studies had also shown a clinical improvement in
      HbA1C values at the six-month, with a p=0.004 (Jaipakdee et al., 2015) and p<0.05. In
      comparison, two studies had demonstrated no clinical improvement at the 6-month, with a p=
      0.94 and p=0.334 respectively. Similarly, Krebs et al., (2013) had shown insignificant HbA1C
      values at 9-month (p=0.22) and whereas, Collins-McNeil, Edwards, Batch, Benbow, McDougald,
      and Sharpe (2012) reported significant result (p=0.1) after a 12-weeks diabetes educational
      program. There is a positive association (p<0.001) between HbA1C values and motivational
      factors after adjustment for potential confounders, such as gender, age, body mass index and
      diabetes knowledge (Nouwen et al., 2011). This means that negative proposition, such as
      depression, portends poorer control of diabetes mellitus; higher HbA1C values.

      The clinical management and advice via the traditional consultation approach are insufficient
      to achieve good diabetes management and glycemic control (Krebs et al., 2013). There is a gap
      between applications of knowledge to actualize self-efficacy behaviors among the type 2
      diabetic patients. Drawing the voices of diabetes patients' perspective on the barriers to
      better diabetes management and glycemic control could avoid miscommunication. Most studies
      had explored the barriers and facilitators in diabetes self-management and education. The
      facilitators that emerged were having good relationship with health care professionals,
      simple and practical instructions and favorable community environment, although it was
      suggested to improve the collaboration between primary and secondary care (Raajimakers et
      al., 2013). The five barriers that emerged were physical barriers (knowledge deficit),
      psychological barriers (over dependence on western medication despite disliking them; lack of
      motivation and self-competency to follow guidelines), social barriers (family role
      expectations, cuisine culture, lack of trustworthy information sources, confusing health
      information, lack of awareness of lifestyle programs; prevention initiatives and social
      support, and communication deficit between patient-practitioner), and care system barriers
      (restriction of reimbursement regulations). Shen et al. (2013) added that the latter barrier
      had also resulted in a reduction of filial responsibility in China due to the cultural
      inferences of the one-child policy. These findings supported that self-efficacy and diabetes
      knowledge is crucial in diabetes management and control.

      The use of smartphones and mobile apps has grown exponentially over the years, with
      technologies touching the remote corners of the globe. Seidel et al. (2014) echoed that 83%
      of the high-risk group for type II diabetes (mean age of 52.7 years old) prefers
      technology-based or telephone-supported program than class-based and that the Asians are more
      likely to choose technology-based program than the Whites. Apparently, half of the causal
      gamers (participants) fall within the age range of 35 to 64 years old. Mobile health
      technologies include telemonitoring, web-based program and mobile platform applications, all
      of which, had demonstrated a positive impact on diabetes-related outcomes and
      clinician-related outcomes, by addressing issues related to missing medications and finishing
      prescribed medication. To elaborate, computer-based technology and web-based program promoted
      knowledge retention and enhanced diabetes knowledge; behavior and HbA1c level that includes
      reduced hypoglycemia episodes. Hence, it could be a potential alternative to group lectures
      for diabetes self-management education.

      On the other hand, apps are downloadable programs designed to operate on smartphone operating
      system, and the use of smartphones apps had sustainable benefits in relation to behavioral
      change and successfully engage the type 2 diabetics, thereby gaining motivation to interpret
      and use the contents better accordingly to one's needs. The key point in using mobile apps is
      to improve user experience so as to enhance engagement. A study conducted in South Caroline
      reported a 0.5% reduction means of the HbA1c level after mobile health intervention over a
      six-months follow-up. However, this intervention should not only restrict to sms alone as it
      offers a new and promising platform for connecting patient to meaningful resources, by
      serving as a practical bridge between health care and community-based resources that promote
      diabetic self-efficacy, behavioral modification, and all those related to improving
      diabetes-related health outcomes. Next, it also has the potential to tailor health
      communication and transform health service delivery on a global perspective concerns.

      Gaming is defined as a tool to present complex and real-world problems, linking theory to
      real-life situations through the application of principles, theory, and concepts.
      Gamification involves games that are designed with practical training objective or simulation
      that includes the presentation of factual knowledge and psychomotor skills. The design of
      avatars in prototype gamification linked gaming to "real-life" situations or clinical
      settings, and thus, allowing for a more realistic interface to the players. Their advantages
      are in enhancing the learners' skills through mastery performance, and comprehension of
      diabetes-related knowledge through observational learning at own pace.

      Games may be served as an assessment tool and are good resources for people with lower
      literacy level as it permits repetitive usage and learning at own pace. The more the
      participants engaged with games, the higher the sense of being "in control", "important" and
      "empowered". In contrast, the longer the duration of attention retention through games, the
      greater the exposure and likelihood of a behavior change. The effectiveness of gaming was
      reflected by an improvement seen in self-efficacy, symptom management and knowledge gained
      through active participation. Games can also address few unmet needs, such as, retaining of
      contents and information through repetitive playing and learning; compare and contrast
      information resource; allowing clinicians to keep tracks on the games scores; a sense of
      control over own body and challenging reality of everyday life.

      Another important key aspect to take note when developing informatics technology, is the
      health status of an individual, in view that the diabetes people with disabilities are less
      likely to use the internet than others due to the lack of access, expertise and physical
      conditions that made the Internet use difficult. There was a study limitation in reporting
      the effectiveness and feasibility of games for type 2 diabetes patients. Eagleson et al.
      (2017) supported that the development and implementation of mobile health and web-based
      interventions are not well documented and fragment in the current literature. The concerns
      being raised were that either the mobile application was developed in an American context
      with different guideline recommendations that may influence the effectiveness and utility in
      different context, or that, the gaming platforms were either outdated or short shelf life,
      which can result in confusion due to uncertainty about reliability, security, regulation and
      integration concerns. In addition, the games are also not updated with new scenarios
      regularly on a long-term basis.

      The other flip sides of mobile gaming application include the inability to address the
      psychological (human factors), motivation, provider-patient miscommunication (health care
      system) and social-economic aspects, which can affect self-management or manageability, and
      that, it can be costly and time-consuming in the development process. It was recommended to
      consider these prior developing a gaming application, which were (i) using a highly
      personalized and user-centered system for compliance and educational needs, (ii) input an
      interactive tool, such as dragging food into a plate, (iii) input a nursing workstation for
      accessibility of information and problem-solving solutions, and lastly, (iv) input sharing
      forum and interactive quizzes.

      Mobile apps could be an innovative way of learning or packaging in diabetes education.
      Although a pilot study conducted in California reported that their bilingual diabetic program
      demonstrated that improved knowledge might not be required to improve positive behaviors, but
      it aids in preventing errors while using diabetes technology. Individual using technology has
      a better understanding and knowledge on DM. The impact of increased knowledge can firstly,
      influence the individual's understanding and perception of how diabetes is being viewed,
      based on one's experience and the information retrieved from social media, family and
      friends, especially those with diabetes. This, in turn, can either act as a motivator or
      barrier to their cognitive domain. The challenge ahead is to implement steps to trigger the
      meaningfulness out from that individual, so as to engage him/her in lifestyle modification
      and taking ownership of own health, such as healthy eating, foot care, and medication
      adherence. Secondly, knowledge influence individual's adherence to medication, self-care and
      treatment plan, which can enhance HbA1C level, and promote self-efficacy and health
      behaviors, such as self-monitoring of blood glucose level. Diabetes patients feel empowered
      once they have sufficient knowledge to make rational decisions, sufficient control, and
      resources to implement their decisions, and sufficient experience to evaluate the
      effectiveness of their decision. Thus, enhance QoL and reduces mental health concerns, such
      as anxiety and depression. Improving the quality of life could result in better motivation
      and social activity.

      There is a dearth of knowledge on in these areas: firstly, there is a study limitation in
      integrating socio-cognitive framework and self-efficacy into designing a gamification
      diabetic educational program, which includes evaluating its feasibility as an assessment tool
      in diabetes education. Secondly, there is a lack of uniformity and consistency in teaching
      contents, delivery of health policy and culturally congruent services in a multi-facet
      country. Thirdly, there is a study limitation in using randomized control trial design to
      evaluate the effectiveness of the empirical gamification diabetes educational program on
      HbA1c values, self-efficacy, sense of coherence and quality of life. This study will firstly,
      add to the growing research on using gamification application as an education tool in the
      diabetic population, and secondly, serves to transform workforce and redesign patient
      education process for type II diabetes patients that include achieving optimum productivity
      and delivering of value-added services that meet the needs of the future healthcare system.
    

Intervention name(s): Gamification Diabetes Education Program (GDEP)
Intervention type(s): Device
Intervention description(s): "Diabetic application" focuses on diabetes management and consists of two gamelets and consist of story-telling, case scenarios with the integration of problem-based decision-making and solving skills in diabetes management. These scenarios created are familiar to the patients and nurses - to make the games more interactive and realistic to the players (participants). Immediate feedback will be given after they select their decision. The visual reward will appear after attaining one score for each correct question. Participants can easily access and play the games several times till contents are reinforced and knowledge is retained or at their own comfort level. This game mechanics aim to motivate and assist patients to achieve their desired result and self-efficacy behaviors. It addresses the deficits from the current literature review, by aiming to be up-to-date, reliable with new updated scenarios and platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study adopted a randomized controlled trial (RCT) design, comparing between intervention group (receiving GDEP) and control group (current practice). In this study, the RCT study design allows comparison between the intervention (GDEP), which will then prove the hypotheses and serves to address the aim of this study.
Masking: None (Open Label)
Primary purpose: Other