Timing of data collection
Variable | Information visit | Visit 1 (0–1 weeks) | Visit 2 (5 weeks) | Visit 3 (17 weeks) | Visit 4 (21 weeks) |
Informed consent | x | x | |||
Baseline information on current illness and medical history | x | ||||
Screening blood samples* | x | ||||
Start-up EMA | x | x | |||
Shift to Plenadren | x | ||||
QoL questionnaire: Fatigue Impact Scale AddiQoL SF-36 | x | x | |||
DEXA-scan | x | x | |||
24 hours blood pressure | x | x | |||
Blood samples | x | x | |||
Salivary cortisol (3 days) | x | x | |||
Recording of adverse events, adverse reactions and the need for rescue medication | x | x | x | x |
*Screening blood samples corresponds to the annual biochemical assessment in pituitary patients at the Department of Endocrinology, Copenhagen University Hospital Rigshospitalet. Fasting is not necessary.
AddiQoL, Addison Disease-specific quality of life; DEXA, dual-energy X-ray absorptiometry; EMA, ecological momentary assessment; QoL, quality of life; SF-36, Short Form Health Survey.