The Effect of Cognitive Appraisal Theory on Adherence in Rehabilitation Training Games for Children With Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 8-Item Morisky Medication Adherence Scale (MMAS-8):
研究概览
简要总结
A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.
详细描述
The experimental group was subjected to a 20-minute daily, 4-week intervention experiment, which included a story background on the start page, eye patches to be put on according to the guidelines, fine eye training, and visual stimulation training, with short breaks between the different modes. The control group was given an experimental intervention using a competing product, with the same duration and format as the experimental group. After completion of the intervention, the participating children completed the MMAS-8 adherence scale with the help of their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of amblyopia (including refractive amblyopia, strabismic amblyopia and mixed).
- •The child has no significant IQ deficits and has no difficulty communicating with others.
- •The children's teachers and parents gave their informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.
排除标准
- •Severe amblyopia.
- •Suffering from other psychological or physical disorders.
- •Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.
研究组 & 干预措施
Find You! Cure My Animal Friends
Participants in the experimental group completed the game in this app. The goal of the game is to guide the amblyopic children to develop the habit of rehabilitation training, so that the amblyopic children will keep their interest in completing the exercises according to the time in the game. A story of an animal intern doctor is constructed, and the player will play the role of an animal doctor according to the guidance of the plot, wear the corresponding eye patches and complete the set visual training tasks in the game. The study aims to improve the overall treatment adherence by increasing the attractiveness of the visual training game to children, cultivating long-term training habits, and mitigating the negative effects of amblyopia treatment. The path to achieve this goal consists of the following components: (1) narrative content, (2) interactive forms combined with masking therapy, (3) incentives, and (4) visual design that is consistent with children's preferences.
干预措施: Find You! Cure My Animal Friends (Device)
DuoBao Vision Training System
Software Co.'s DuoBao Vision Training System. A number of visual function tests and ophthalmology strabismus amblyopia specialist examinatio. The data is transmitted to the data center and the expert intelligent system to develop a targeted personalized amblyopia training program. Control group participants completed the training components in this app.
干预措施: DuoBao Vision Training System (Device)
结局指标
主要结局
8-Item Morisky Medication Adherence Scale (MMAS-8):
时间窗: baseline and study completion (after 8 weeks)
A patient's adherence to therapy can be evaluated using the eight-question Morisky Medication Adherence Scale-8 (MMAS-8).The total score of the MMAS-8 scale is the sum of the scores of the above 8 questions, and the score range is 0\~8. Higher scores indicate better medication adherence. 8 indicates good adherence; 6\~7 indicates moderate adherence; \<6 indicates poor adherence.
次要结局
- User Experience Questionnaire (UEQ)(study completion (after 8 weeks))
研究者
Zhu Dian
Principal Investigator
Shanghai Jiao Tong University School of Medicine