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