Skip to main content

Table 2 Variables, measurement and data collection points

From: The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial

  

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

 

View full size image

Secondary outcomes

Healthcare utilisation costs

FIMA© (10 Items) [83]

  

X

X

X

X

X

X

X

X

X

Swiss standardised unit costs [84, 85]

  

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]

 

View full size image

 

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

 
  1. Abbreviations. AIM Acceptability of Intervention Measure, BAASIS Basel Assessment of Adherence to Immunosuppressive Medication Scale, CRF case report form, FIM Feasibility of Intervention Measure. IAM Intervention Appropriateness Measure, MEMS Medication Event Monitoring System, PETS Patient Experiences with Therapy and Self-management, Tx transplantation