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

NCT05432440 | Unknown DMC

• 1 other identifier: 1368/LT/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Poor adherence and self-management in children with asthma results in poorly controlled asthma and increased morbidity. Pharmacists could take important roles in delivering asthma education to ensure that children can manage their disease. This study aims to evaluate the effectiveness of improving asthma control, knowledge, and quality of life. An open, randomized controlled trial will be conducted to evaluate the effectiveness of pharmacist-led digital-based asthma self-management education for children with asthma compared with paper-based asthma self-management education. Recruitment of the participants will be held at the outpatient ward of the Department of Paediatrics in 4 public hospitals in Bali Province, Indonesia, including Sanglah Public Hospital, Denpasar City; Wangaya Public Hospital, Denpasar City; Mangusada Public Hospital, Badung Regency; and Udayana University Hospital, Badung Regency. Participants will be provided with informed consent, then randomly divided into either a control group or an intervention group. The following will be the hypotheses of the study:

1. 1.The intervention group receiving the MIRACLE education program has a better asthma control compared to the control group.
2. 2.The intervention group receiving the MIRACLE education program has a greater improvement in asthma quality of life compared to the control group.
3. 3.The intervention group receiving the MIRACLE education program has a better understanding of asthma knowledge in general compared to the control group.
4. 4.The intervention group receiving the MIRACLE education program has a better performance in practicing inhaler techniques compared to the control group.
5. 5.The intervention group receiving the MIRACLE education program has fewer unscheduled visits to the hospital and less hospitalization compared to the control group.
6. 6.The intervention group receiving the MIRACLE education program will be satisfied with the digital asthma education.

Conditions

Asthma in Children; Asthma Chronic; Asthma

Keywords

asthma; children; serious game

Outcome Measures

Primary Outcomes (1)

• Asthma Control as assessed by Asthma Control Questionnaire (ACQ).

  The primary outcome will be the changes in asthma control. The Indonesian version of the Asthma Control Questionnaire (ACQ, proposed by Juniper et al, 1995) is a validated measure of a patient's abilities to control asthma. It composes of 5 questions about asthma symptoms, 1 question about bronchodilator use during the previous week, and 1 question about FEV1% change. All questions will be scored 0 to 6, and a total score will be expressed as the mean of these scores. Asthma control will deteriorate as the score increase. A clinically important change in ACQ score will be reported to be 0.5. If the post-test score will be lower than the pretest score, it will be indicated that asthma control will be improved. Patients will be asked to recall their experiences during the previous 7 days and will respond to the questions using a 7-point scale.

  2 months

Secondary Outcomes (7)

• Asthma Quality of Life assessed by Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

  2 months

• The level of asthma knowledge, assessed by Asthma Knowledge Questions

  2 months

• Number of Correct Inhaler Techniques Performance, assessed by Indonesian Inhaler Practice Checklist

  2 months

• number of unscheduled visits

  2 months

• number of hospitalization

  2 months

Study Arms (2)

Intervention group (the digital asthma education program)

EXPERIMENTAL

The intervention group receives the digital asthma education program (MIRACLE program). It consists of an asthma interactive narrative, a serious game, and an asthma action plan. It mainly covers asthma self-management and asthma attack prevention, such as asthma definition, asthma triggers and how to prevent asthma triggers exposures, asthma medications, proper inhaler technique, and asthma written action plan. The time schedule will be described as: 1. Explain study purposes, program, procedures, and instructions (10 minutes). 2. Accompany children and parents to download and install the MIRACLE program on Google Play Store for free on their personal computers, tablets, or smartphones (5 minutes). 3. Asthma education will take place over one session lasting approximately 45 minutes.

Behavioral: The digital asthma education program

Control group (the booklet asthma education program)

ACTIVE COMPARATOR

For the control group, a pharmacist (same personnel) will provide an asthma education using a booklet for 45-60 minutes to children and parents. Patients will be asked to read the booklet at home for 15 minutes in 7 days. It mainly covered the same content as the MIRACLE program. The time schedule will be described as: 1. Explain study purposes, booklet, procedures, and instructions (10 minutes). 2. Asthma education will take place over one session lasting approximately 45 minutes.

Behavioral: The digital asthma education program

Interventions

The digital asthma education program BEHAVIORAL

The intervention group receives the digital asthma education program (MIRACLE program). It consists of an asthma interactive narrative, a serious game, and an asthma action plan. It mainly covers asthma self-management and asthma attack prevention, such as asthma definition, asthma triggers and how to prevent asthma triggers exposures, asthma medications, proper inhaler technique, and asthma written action plan.

Control group (the booklet asthma education program); Intervention group (the digital asthma education program)

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with asthma, asthma was diagnosed by a medical doctor, pediatrician, or medical records.
• Children with asthma in the range age of 6 - 13 years old.
• Had a history of asthma or had a previous asthma attack in 1 year.
• Able to communicate in Bahasa Indonesia and pose to use a computer, tablet, or smartphone.
• No serious cognitive impairments.
• Agree to participate in the study and follow the instructions.

You may not qualify if:

• Disagree to participate in the study.
• Had another history of respiratory diseases or conditions that may affect responses.

Sponsors & Collaborators

• Udayana University: lead

Study Sites (4)

Mangusada Teaching Hospital

Badung, Bali, 80116, Indonesia

Location

Udayana University Hospital

Badung, Bali, 80116, Indonesia

Location

Sanglah General Hospital

Denpasar, Bali, 80234, Indonesia

Location

Wangaya Teaching Hospital

Denpasar, Bali, 80234, Indonesia

Location

Related Publications (1)

• Sarasmita MA, Larasanty LPF, Kuo LN, Cheng KJ, Chen HY. A Computer-Based Interactive Narrative and a Serious Game for Children With Asthma: Development and Content Validity Analysis. J Med Internet Res. 2021 Sep 13;23(9):e28796. doi: 10.2196/28796.

  PMID: 34515641 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hsiang Yi Chen, Prof

  Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Made Ar Sarasmita, MClinPharm

CONTACT

+6281703911305; arysarasmita@unud.ac.id

Hsiang Yi Chen, Prof

CONTACT

+8860227361661; shawn@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors for collecting outcome data at 1 and 2 months will be masked to group allocation. They will also be prohibited to contact patients directly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist, Department of Pharmacy, Faculty of Mathematics and Science, Udayana University; PhD student, Department of Clinical Pharmacy, Taipei Medical University, Taipei, Taiwan

Model Details: After informed consent provision and baseline assessment, participants will be allocated into two groups, including the intervention group (IG) and the control group (CG). The intervention will be a computer-based asthma self-management education entitled Module of Inhaler and Asthma Triggers for Children (MIRACLE) and usual care. It will consist of interactive narratives and a serious game, an asthma action plan, and a video of the inhaler technique. The control group will receive a paper-based asthma education (booklet) and usual care. The study duration will be set for 2 months by applying those media for 7 days at home and the minimum required time for using the MIRACLE program will be 15 minutes per day. Two groups will be equipped with a peak flow meter and an asthma action plan, and they will be encouraged to write their daily symptoms and activities in a diary.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: August 20, 2022
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)