Table 3.
Time and Events Schedule
| Visit | V0 | V1 Part 1a | V1 Part 2b | V2 | V3 | V4 | V5 | V6 Part 1a | V6 Part 2b | 
|---|---|---|---|---|---|---|---|---|---|
| Time Window (weeks) | −12 to −10 | −10 to −6 | −6 to −2 | 2–4 | 5–7 | 11–13 | |||
| Target (week) | −11 | −8 | −4 | 0 | 3 | 6 | 12 | ||
| Type of visit 1 | Pre V1 Eligibility | Phone | Clinic | iPad/ FaceTime | iPad FaceTime | iPad FaceTime | iPad FaceTime | iPad FaceTime | Clinic | 
| Trial Randomization | x | ||||||||
| Consent | x | ||||||||
| Eligibility evaluation2 | x | x | x | x | |||||
| Procedures | |||||||||
| Pregnancy test | x | ||||||||
| Blood (DNA, allergy) | x | ||||||||
| Height and Weight3 | x | x | x | x | x | x | |||
| Vital Signs | x | x | |||||||
| Physical Exam | x | x | |||||||
| Treatment Randomization5 | x | ||||||||
| Consent Interview | x | x | |||||||
| Exhaled nitric oxide (selected sites) | x | x | |||||||
| Spirometry Pre and Post 6 | x | x | x | x | x | ||||
| Questionnairesc | |||||||||
| Screening Form | x | x | |||||||
| Baseline asthma and medical history | x | ||||||||
| Asthma Control Test | x | x | x | x | x | x | |||
| Children’s Health Survey for Asthma | x | x | x | x | |||||
| Clinic Visit Form | x | x | x | x | x | ||||
| EQ-5D | x | x | |||||||
| Quality of Life | x | x | x | x | |||||
| Complete Morning and Evening reports on iPad | x | x | x | x | x | ||||
| Medication and device distribution | |||||||||
| Treatment medication distribution4 | x | x | x | x | x | x | x | ||
| iPad Daily Report/PEF/AAP review | x | x | x | x | x | x | |||
| Receive/Return iPad and EasyOne8 | x | X | |||||||
Conducted during FaceTime visit
Conducted at clinic site
Questionnaires are completed online prior to each iPad/FaceTime visit