Evaluation of Pharmacist-guided Digital-based Asthma Education for Indonesian Children With Asthma

Description A randomized controlled trial will be conducted in four teaching hospitals in Bali, Indonesia. The module on inhalers and asthma triggers (MIRACLE) had been developed using cultural adaptation and growth mindset elements for Indonesian children with asthma. It consists of an interactive narrative and a serious game. The intervention group will receive the MIRACLE program and written asthma plan, and the control group will receive an asthma booklet. A pharmacist will deliver the education to both groups.

Randomization and Allocation Recruited participants will be allocated to the intervention or control group on a 1:1 basis. Randomization and allocation will be conducted at each research site. Assignment numbers will be printed and sealed in opaque envelopes according to a predefined order. The envelopes will be stored in a secured cabinet. Block randomization will be performed on the basis of 2 units and random numbers will be generated using a random allocation software program by an external researcher not involved in the study. The block size will be confidential. Group assignment will be concealed until children and parents complete the consent procedures. At the time of recruitment, the researchers coordinating this study will open the numbered envelope and will allocate each participant to the control group (paper-based asthma health education) or the intervention (computer-based asthma education/the MIRACLE program) using a secured computer file. A pharmacist will administer the intervention and will be aware of the allocated groups. Due to the nature of the study, participants may be aware of the existence of the alternative group. To minimize bias, the assessors who will assess the baseline and follow-up measures will not be aware of the allocation.

Sample size calculation We will use G-Power software (version 3.1, Heinrich-Heine-Universität Düsseldorf, Germany) to calculate the estimated sample size of this study. Assuming a power of 80% with a two-sided alpha level of 0.05 to detect the difference between the intervention group and the control group, at least 36 participants were needed for each group. We will anticipate a low rate of follow-up attrition (20% dropout) and consider a sample size of 50 per group, an estimated 100 participants in total.

Study procedures Before study Before conducting the study, one pharmacist will undergo training provided by a certified asthma educator. This study will evaluate a digital-based intervention involving pharmacists in delivering patient education and counseling. A checklist form will be filled out when the pharmacist delivers asthma education to both groups.

Recruitment The recruitment process will be accompanied by pediatricians and nurses in the hospitals. Potentially eligible participants will be identified through 2 pathways: 1) first, the pediatricians will identify all children with asthma visiting the outpatient hospitals on the date of each patient's clinic visit. A research assistant will approach potential participants and will perform screening on the eligibility, then we will provide an explanatory statement, an informed consent, and a child assent form to the patients and parents. Potential participants will be asked to leave their contact details to allow one of the research assistants to contact them, or 2) second, through the electronic medical record (EMR) system in the hospitals, and then identified patients will receive a phone call, a short message, or an email. Written informed consent and child assent form from the patient and parents/guardians will be sought after the explanation procedure. Participation in this study will be voluntary and without any force to them. The subjects have the right to withdraw from the study at any time and there will be no adverse effect on their medical treatments. The reasons for not participating in patients deem ineligible or decline to participate during the follow-up session will be recorded.