Table 1.
Assessment time points for primary and secondary outcomes of SMART-CR/SP study
Outcome | Assessment | Baseline | 8 week | 6 month | 12 month |
Primary outcome | |||||
Exercise capacity | Change in 6MWT distance | ✔ | ✔ | ✔ | |
Key secondary outcome | |||||
Knowledge of the disease | Modified CHD questionnaire42 43 | ✔ | ✔ | ✔ | ✔ |
Secondary outcomes | |||||
Blood pressure | Average of two resting, sitting digital recordings | ✔ | ✔ | ✔ | |
Lipid profile | Fasting blood sample | ✔ | ✔ | ✔ | ✔ |
Medication adherence | Adherent to cardiac-protective medications | ✔ | ✔ | ✔ | ✔ |
Smoking | Self-report | ✔ | ✔ | ✔ | ✔ |
Obesity | Weight, height, waist and hip circumference | ✔ | ✔ | ✔ | |
Physical activity | General Physical Activity Questionnaire46 | ✔ | ✔ | ✔ | ✔ |
Fruit and vegetable intake | WHO Steps instrument44 | ✔ | ✔ | ✔ | ✔ |
Anxiety symptoms | Generalised Anxiety Disorder 7-item (GAD-7) scale47 | ✔ | ✔ | ✔ | ✔ |
Depressive symptoms | Patient Health Questionnaire (PHQ-9)48 |
✔ | ✔ | ✔ | ✔ |
Quality of life | SF-12_V2 Health Survey49 | ✔ | ✔ | ✔ | ✔ |
CV events | CVD death, non-fatal AMI, stroke or hospital admission with unstable angina or congestive heart failure | ✔ | ✔ | ✔ | |
CR/SP needs survey | Patient needs for the core components of CR/SP33 | ✔ | ✔ | ✔ | ✔ |
All-cause mortality | Data from CDC | ✔ | ✔ | ✔ |
AMI, acute myocardial infarction; BP, blood pressure; CDC, Centre Disease Control and Prevention; CHD, coronary heart disease; CR/SP, cardiac rehabilitation and secondary prevention; CV, cardiovascular; LDL, low-density lipoprotein; 6 MWT, 6 min walk test distance.