Table 2.
ACTIVATE protocol schedule of forms and procedures
| Procedures | Screening | Baseline/randomisation | 7 days postrandomisation* | Trial intervention† | 26 weeks postrandomisation | 27 weeks postrandomisation* | 52 weeks postrandomisation | 53 weeks postrandomisation* |
| Eligibility screening and consent | ||||||||
| Assessment of eligibility | X | |||||||
| Informed consent | X | |||||||
| Confirm consent | X | X | X | X | ||||
| Randomisation | X | |||||||
| Vital signs, height, weight, serum cholesterol | X | |||||||
| Outcome measurement | ||||||||
| Seattle Angina Questionnaire | X | X | X | |||||
| MRC dyspnoea scale | X | X | X | |||||
| Hospital Anxiety and Depression Scale | X | X | X | |||||
| General Self-Efficacy scale | X | X | X | |||||
| EQ-5D-5L | X | X | X | |||||
| Client Service Receipt Inventory | X | X | X | |||||
| Physical activity measured with ActivPal accelerometer | X | X* | X | X* | X | X* | ||
| International Physical Activity Questionnaire | X | X | X | |||||
| Incremental shuttle walk test | X | X | X | |||||
| Safety event reporting | ||||||||
| Monitoring of adverse events | X | X | X | X | X | X | ||
| Monitoring of serious adverse events | X | X | X | X | X | X | ||
*Removal of ActivPal after 7 days.
†If randomised to intervention arm, participants will be invited to meet with member of cardiac rehabilitation staff who will train the participant on how to use the intervention.
EQ-5D-5L, EuroQol-5 Dimensions-5 Levels.