Table 1.
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Device assessment period | Clinical feasibility study period | ||||||
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Screening | Baseline visit | Interim visit | Final visit | Interim visits | Final visit | |||
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
Days | 1 | 7 | 14 | 21 | 28 | 35 | 56 | 90 | |
Informed consent process | ✓ |
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Study eligibility and smoking status | ✓ |
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Reviewing medical history (including physical examination and BMIa measurement) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
COPDb assessment test | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Spirometry | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
6-minute walk test | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Providing the study requirements handout and explaining the study/visit requirements | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Dichotomous questionnaire for visit readiness | ✓ |
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Providing mHealthc devices | ✓ |
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Assessment of AnaMed OEMd device |
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Continuous monitoring | |||||||
Assessment of Air Next mobile spirometer against standard |
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Continuous monitoring |
aBMI: body mass index.
bCOPD: chronic obstructive pulmonary disease.
cmHealth: mobile health.
dOEM: original equipment manufacturer.