Table 1 Schedule of activities and measures for the RCT and implementation study. All psychometric instruments are scientifically validated and reliable
PROJECT STAGE (number of participants) | RCT (N = 120) Pilot and main study phase) | Implementation phase (N = 100) | |||||||
|---|---|---|---|---|---|---|---|---|---|
TIMELINE/PHASES (D- day, W: week; M: month; Ph: phase) | -7D to 0D | 0D | 10 W | 6 M | 12 M | Fortnightly | Ph-1 to Ph-5 | ||
RECRUITMENT | ACTIVITIES | Mode of data collection | |||||||
Screening | Eligibility checklist | In-person | ✓ | ||||||
ISCoS cardiovascular function dataset | In-person | ✓ | |||||||
ISCoS pulmonary function basic data set | In-person | ✓ | |||||||
Consent procedure | Informed consent procedure | In-person | ✓ | ||||||
PARTICIPANT DESCRIPTORS | ASSESSMENTS | Mode of data collection | |||||||
Socio-demographics | Socio-demographics details | In-person or online | ✓ | ||||||
Pre-injury details | Employment history and psychological status | In-person or online | ✓ | ||||||
Medical history | Self-report past/present health history | In-person or online | ✓ | ||||||
Injury characteristics | Level of lesion, AIS and FIM | Medical records | ✓ | ||||||
Pulmonary function | Pulmonary function test | In-person | ✓ | ||||||
ALLOCATION | DESCRIPTION | Mode | |||||||
Intervention group | HRV-F + Usual care | In-person and online |
| ||||||
Control group | Usual care | Online |
| ||||||
PRIMARY OUTCOMES | OUTCOME MEASURE | Mode of data collection | |||||||
Autonomic function | ECG/ HRV Time domain – Short term | In-person | ✓ | ✓ | |||||
ECG/ HRV Frequency domain – Short term | In-person | ✓ | ✓ | ||||||
Cerebral basal artery blood flow | Doppler assessment – Short term | In-person | ✓ | ✓ | |||||
SECONDARY OUTCOMES | OUTCOME MEASURE | Mode of data collection | |||||||
Autonomic function | ECG/ HRV Time domain – Long term | In-person | ✓ | ✓ | ✓ | ||||
ECG/ HRV Frequency domain – Long term | In-person | ✓ | ✓ | ✓ | |||||
ADFSCI questionnaire | In-person | ✓ | ✓ | ✓ | ✓ | ||||
Cerebral basal artery blood flow | Doppler assessment – Long term | In-person | ✓ | ✓ | ✓ | ||||
Neurophysiological function | Continuous BP | In-person | ✓ | ✓ | ✓ | ✓ | |||
EEG | In-person | ✓ | ✓ | ✓ | ✓ | ||||
NIRS | In-person | ✓ | ✓ | ✓ | ✓ | ||||
EOG | In-person | ✓ | ✓ | ✓ | ✓ | ||||
Skin conductance, BVP, respiration and temp | In-person | ✓ | ✓ | ✓ | ✓ | ||||
Secondary health conditions | SCI-SCS | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Cognitive function | NUCOG | In-person and online | ✓ | ✓ | |||||
Stroop test | In-person and online | ✓ | ✓ | ||||||
Psychological/mental health function | GADS | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
PHQ-9 | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
Psychosocial function | ISCoS pain questionnaire | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
FSS | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
PSQA | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
PCS | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
Personal factors | CD-RISC2 Short Form | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Quality of life | EQ-5D-5L | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Participation and disability | WHODAS domain – participation items | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Consumer perception and satisfaction | Self-reported perception of change and satisfaction | In-person and online | ✓ | ||||||
Costs for Economic evaluation | Self-reported direct and indirect costs | Diaries (up to 12 m) | ✓ | ||||||
Adverse events | Self-monitoring of Adverse events | Diaries (up to 12 m) | ✓ | ||||||
Self-monitoring of mood, breath rate, pain, fatigue and sleep quality | Numeric rating scale (0 to 10) | Diaries (up to 12 m) | ✓ | ||||||
EXPLORATORY OUTCOMES | OUTCOME MEASURE | Mode of data collection | |||||||
Personal factors | WHO ASSIST | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
COPE inventory – brief | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
ADAPSS – Short-form | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
MSES | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
Psychological/mental health function | PTSD Checklist 5 | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Psychosocial function | SSQ6 | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Berlin Questionnaire | In-person and online | ✓ | ✓ | ✓ | ✓ | ||||
Environmental factors | Care, family and compensation status questionnaire | In-person and online | ✓ | ✓ | ✓ | ✓ | |||
Participation and disability | RTW Questionnaire | In-person and online | ✓ | ||||||
IMPLEMENTATION OUTCOME | MEASURE | Mode of data collection | |||||||
Qualitative/ quantitative assessment | Stakeholder interviews and surveys | In-person and online | ✓ | ||||||
