|  | Measurement timepoints (T0 – Tz) and days post-Tx | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Variables | Measurements | T0a | T0b | T1 | T2 | T3 | T4 | T5 | T6 | T7 | T8 | Tz |
−10 | 30 | 60 | 90 | 120 | 150 | 180 | 240 | 300 | 365 | 455 | ||
Primary outcome | ||||||||||||
 Re-hospitalisation rate (number of re-hospitalisations per patient year) | FIMA© (10 Items) [83] Medical Records, CRF |  | ||||||||||
Secondary outcomes | ||||||||||||
Healthcare utilisation costs | FIMA© (10 Items) [83] |  |  | X | X | X | X | X | X | X | X | X |
 |  | X | X | X | X | X | X | X | X | X | ||
 Length re-hospitalizations | FIMA© (10 Items) [83] Medical Records, CRF |  |  | X | X | X | X | X | X | X | X | X |
 Medication adherence (implementation & persistence dimension [67]) | Electronic Monitoring: MEMS® Button [86] |  |  | |||||||||
BAASIS© (implementation 4 items; persistence: 1 item) [87] |  | X | X | X | X | X | X | X | X | X | X | |
 Treatment burden | PETS© (60 items) [88] | X |  |  | X |  |  | X |  |  | X |  |
 Health-related Quality of Life | EQ-5D-5L© (5 items) [89] | X | X | X | X | X | X | X | X | X | X | X |
 Quality-Adjusted Life Year (QALY) | EQ-5D-5L© (5 items) [89], value set for Germany EQ-VT v. 2.0 (116) | X | X | X | X | X | X | X | X | X | X | X |
 Incidence/grade chronic and acute GvHD | Medical record, CRF |  | X | X | X | X | X | X | X | X | X |  |
 Overall survival rate | Medical record, CRF |  | X | X | X | X | X | X | X | X | X | X |
 Conditioning regimen | Medical record, CRF | X |  |  |  |  |  |  |  |  |  |  |
 Donor match/type | Medical record, CRF | X |  |  |  |  |  |  |  |  |  |  |
 Disease | Medical record, CRF | X |  |  |  |  |  |  |  |  |  |  |
 Disease status at transplant | Medical record, CRF | X |  |  |  |  |  |  |  |  |  |  |
 If death: Date and cause of death | Medical record, CRF |  | X | X | X | X | X | X | X | X | X | X |
 If relapse: Date of relapse | Medical record, CRF |  | X | X | X | X | X | X | X | X | X | X |
Demographics | ||||||||||||
 Age | Medical Record, CRF | X |  |  |  |  |  |  |  |  |  |  |
 Sex | Medical Record, CRF | X |  |  |  |  |  |  |  |  |  |  |
 Education | Questionnaire (4 items) | X |  |  |  |  |  |  |  |  |  |  |
 Living alone | Questionnaire (1 item) | X |  |  |  |  |  |  |  |  |  |  |
IMPLEMENTATION OUTCOME DATA (from intervention group / care coordinator team) | ||||||||||||
 Acceptability | AIM (4 items) [90] | X | X | X | X | X | X | X | X | X | X |  |
 Appropriateness | IAM (4 Items) [90] | X | X | X | X | X | X | X | X | X | X |  |
 Feasibility | FIM (4 items) [90] | X | X | X | X | X | X | X | X | X | X |  |
 Technology feasibility | N (days with data entry), N (technical problems) |  | ||||||||||
 Intervention fidelity | N (visits), Minutes (visits), N (Behavioural Change Techniques) compared to protocol |  | ||||||||||
 Intervention fidelity | 5% of intervention sessions will be randomly selected to be audiotaped and checked for protocol congruence |  |