Table 1.
Schematic SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) schedule of enrollment, interventions, and assessments.
| Time point | Study period | ||||||
| Enrollment | Allocation/first visit | Postallocation | Closeout/end visit | ||||
| −t1 | t0 | t1 Intervention period: 3 months |
t2 middle visit |
t3 follow-up period: 3 months |
te | ||
| Enrollment | |||||||
| Eligibility screen | ✓ | ||||||
| Informed consent | ✓ | ||||||
| Instruction and installment eHealth | ✓ | ||||||
| Allocation | ✓ | ||||||
| Interventions | |||||||
| eHealth care (the Engage web portal, spirometry, pulse oximetry, smart inhaler) | ✓(Aa) | ||||||
| Standard care + observational monitoring (spirometry, pulse oximetry, smart inhaler) | ✓(Ba) | ✓ | |||||
| Observational monitoring (cough sensor, air sensor, sleep monitor) | ✓ | ✓ | |||||
| Assessments | |||||||
| Baseline variables (age, gender, BMI, z score, GINAb medication step, allergic rhinitis, asthma-related medical history, and baseline spirometry, such as FEV1c and FVCd |
✓ | ✓ | |||||
| Medical utilization data Number of visits (planned/ emergency/hospital admissions), diagnostic tests, telephonic/internet consultations, total health care costs |
✓ | ✓ | |||||
| Questionnaire evaluations: health literacy (HLSe), asthma control (C-ACTf), quality of life (PAQLQg and EQ-5D-Y), self-management (PAM-13h) |
✓ | ✓ | ✓ | ||||
| Quality of care (CSQi) | ✓ | ✓ | |||||
| Monitoring data: medication use, sleep, nocturnal heart/respiratory rate, nocturnal coughing/ wheezing, air quality, lung function, and oxygen saturation | ✓ | ✓ | |||||
| Intervention data: intervention use logs, and nebulizer use | ✓(Aa) | ||||||
| eHealth–specific evaluations: system usability (SUSj), technology acceptance (TAMk), and interview |
✓(Aa) | ||||||
aDepending on the randomization. Group A receives eHealth care, and group B receives standard care within the intervention period (t1).
bGINA: Global Initiative for Asthma.
cFEV1: forced expiratory volume.
dFVC: forced vital capacity.
eHLS: Health Literacy Survey.
fC-ACT: Childhood Asthma Control Test.
gPAQLQ: Pediatric Asthma Quality of Life Questionnaire.
hPAM-13: 13- Item Patient Activation Measure.
iCSQ: Client Satisfaction Questionnaire.
jSUS: System Usability Scale.
kTAM: Technology Acceptance Model.