The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT03273140|
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : August 22, 2018
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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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Patients, Gamification, Diabetic Education||Device: Gamification Diabetes Education Program (GDEP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|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)|
|Masking Description:||Assessor blinding is not possible as the researcher is involved in the whole process from recruitment to data analysis as part of her doctorate study. However, a research assistant (RA) will assist in arranging the sequence of the envelopes as part of allocation concealment, double-checking of the data entry and analysis of the report. To highlight, the RA will also not know which is the 'control' and 'intervention' group, as both groups will be de-identified as group A and B during the process of data entry and analysis.|
|Official Title:||The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients: A Randomised Controlled Trial.|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||August 15, 2018|
|Actual Study Completion Date :||August 15, 2018|
Experimental: Gamification Diabetes Education Program (GDEP)
The GDEP consists of two components, which are 1) gamification app on diabetes education, and 2) usual care group (face-to-face discussion with a DNE).
1) Gamification: The development of this gamification app, a mobile-based app of serious gaming, addresses the limitation and few recommendations from the current literature review. It aimed to enhance the user experience, and to facilitate diabetes education in an effective and efficient way, aligning with ADA (2014) guidelines, work instructions, and protocols in one tertiary organization. The learning modules are framed by socio-cognitive framework and self-efficacy. The gaming concept has been implemented into a mobile app, which can be accessed via iOS and Android platforms. It takes an average of 15 minutes to complete per stage. Hence, allowing flexibility for participants to access the games anywhere and anytime using i-pad or mobile devices.
Device: Gamification Diabetes Education Program (GDEP)
"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.
No Intervention: Standard group
The control group comprises of the standard care or usual care group, which is the face-to-face session with the DNE. The content during each session is dependent upon the individual's needs and concerns, including the reason for referral to DNE by the endocrinologist. For example, teaching the individual patient on self-management of blood glucose (SMBG) and emphasizing on diet modification and exercise if necessary. Educational pamphlets on diabetes management will be given to him/her if deemed necessary. Each session will usually requires an average of 45 minutes, which is considered as long consultation that costs 16 dollars. On the other hand, short consultation is categorised as less than 30 minutes that costs around eight dollars. The difference is that there is no GDEP in the control group. However, after the completion of data collection at six months time, the control group will also receive the intervention (GDEP). This is in order to give them equal opportunity.
- Better HbA1c values [ Time Frame: Every three months up to 24th week (0 week as baseline, 12th week and 24th week) ]Clinical indicator to monitor glycemic control for the past three months
- Better Self-efficacy [ Time Frame: Every three months up to 24th week (0 week as baseline, 12th week and 24th week) ]Using Self-efficacy tool (Duprez et al., 2013)
- Better Sense of Coherence [ Time Frame: Every three months up to 24th week (0 week as baseline, 12th week and 24th week) ]Using SOC-13
- Better Quality of life [ Time Frame: Every three months up to 24th week (0 week as baseline, 12th week and 24th week) ]Using genetic tool: WHO-BREF
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|Ages Eligible for Study:||21 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Patient who is clinically diagnosed with type 2 diabetes mellitus.
- Patient with HbA1C value > 7% at least within the past two months.
- Patient who can speak and understand English.
- Patient of age 21 to 75 years old.
- Patient with either a smartphone or i-pad/ tablet.
- Pregnant patient.
- Patient diagnosed to have a terminal illness.
- Patient with cognitive impairment.
- Patient with end-stage renal failure (ESRF).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273140
|11 Jalan, Tan Tock Seng Hospital,|
|Singapore, Noverna, Singapore, 308433|
|Responsible Party:||KHO SIOK EE SHARON, Principal Investigator, Clinical Instructor, National Healthcare Group, Singapore|
|Other Study ID Numbers:||
|First Posted:||September 6, 2017 Key Record Dates|
|Last Update Posted:||August 22, 2018|
|Last Verified:||August 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|