Adherence, Treatment, Amblyopia, Amblyopia Occlusion, Child Behavior
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFind You! Cure My Animal Friends
Introduced cognitive evaluation theory combined with masking therapy to develop a gamified product that guides amblyopic children to develop habits for the purpose of rehabilitation training.
DEVICEDuoBao Vision Training System
This is a visual training app where participants are required to complete several training tasks.
Sponsors
Zhu Dian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 8-Item Morisky Medication Adherence Scale (MMAS-8): | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User Experience Questionnaire (UEQ) | study completion (after 8 weeks) | Enabling prompt and accurate user experience measurement is the primary goal of the UEQ.UEQ was administered post-experiment to swiftly and accurately measure user experience. Covering 26 items across six domains, UEQ evaluated the impact of the amblyopia rehabilitation training product on both children and their parents. Due to its language complexity, the questionnaire was completed with parental assistance.1 for disagree, 7 for strongly agree |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDian Zhu, Dr
Shanghai Jiao Tong University School of Medicine
Outcome results
None listed