PPOIT: Resilience and wellbeing
| Trial phase | Screening (pre-trial) |
Randomisation and RUSH day | Build up phase (visit every 2 weeks) |
Maintenance phase (visit every 4 weeks) |
Week 78+ DBPCFC (minimum of 6 months maintenance) |
Post treatment 1 clinic visit (2 – 6 weeks after T1 DBPCFC) |
Post treatment 2 clinic visit (3 months after T1 DBPCFC) |
Post treatment 3 phone interview (6 months after T1 DBPCFC) |
Post treatment 4 clinic visit (12 months after T1 DBPCFC) |
Post treatment 5 clinic visit (3-4 years after T1 DBPCFC) |
Follow up phone/email questionnaires (every 6 months) |
Final email/phone follow up (3 years after T5) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time point | RUSH / T0 | T1 | T2 | T3 | T4 | T5 | ||||||
| Month of study (minimum) | 0 | 0 | 18 | > 18.5 | > 21 | > 24 | > 30 | > 54-66 | > 60-96 | > 90-102 | ||
| Quality of life | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF |
| Trial phase | Sc Screening (pre-trial) |
T0 RUSH day |
Build up phase (visit every 2 weeks) |
Maintenance phase (visit every 4 weeks) |
T2 (final day of study treatment) |
T3 (8 weeks after end of study treatment) |
T4 (1 year after end of study treatment) |
T5 (3 years after end of study treatment) |
|---|---|---|---|---|---|---|---|---|
| Month of study | 0 | 0 | 18 | 20 | 30 | 54 | ||
| Quality of life | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF |
| Trial phase | Screening (pre-trial) |
T0 RUSH day |
Build up phase (visit every 2 weeks) |
Maintenance phase (visit every 12 weeks) |
T1 (1 day after final day of treatment) |
T2 (12 weeks after final day of treatment) |
Telephone Contact (26 weeks after final day of treatment) |
T3 (1 year after final day of treatment) |
|---|---|---|---|---|---|---|---|---|
| Month of study | up to -3 | 0 | 18 | 21 | 24 | 30 | ||
| Week of study | up to -12 | 0 | 78 | 90 | 104 | 130 | ||
| Quality of life | P:FAQLQ-PF | P:FAQLQ-PF | P:FAQLQ-PF |
Featured measurements
FAQLQ: Food Allergy Quality of Life QuestionnaireLegend
| A | = Administration report abstraction |
| C | = Index child report (reporting on others) |
| L | = Linkage (to other databases) |
| M | = Medical records data abstraction |
| O | = Observation/direct assessment |
| N | = Nurse report |
| P | = Parent/primary caregiver report |
| Pe | = Peer report |
| S | = Self report |
| T | = Teacher report |
| X | = Undefined |
| X BF | = Pertaining to biological father |
| X BM | = Pertaining to biological mother |
| X C | = Pertaining to index child |
| X F | = Pertaining to father |
| X Fam | = Pertaining to family |
| X G | = Pertaining to grandparent(s) |
| X M | = Pertaining to mother |
| X P | = Pertaining to parent(s) |
| X Pa | = Pertaining to partner |
| X Pe | = Pertaining to peers |
| X Pr | = Pertaining to primary caregiver |
| X Si | = Pertaining to sibling(s) |