Table 1 Schedule of enrolment, intervention and assessments
Study period (months) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
Baseline | Intervention (allocation) Group-based therapy (5 weeks) | Post-allocation (months) | Close-out | ||||||
Timepoint | 0 | 0 | 1 week | 2 weeks | 3 weeks | 4 weeks | 3 months | 6 months | 12 months |
Enrolment | |||||||||
Eligibility screen | x | ||||||||
Informed consent | x | ||||||||
Allocation of patients | x | ||||||||
Intervention | x | x | x | x | x | x | x | ||
Control | x | x | |||||||
Follow-up visit | x | x | |||||||
Assessments | |||||||||
Background | |||||||||
Cohabitant | x | x | x | ||||||
Level of education | x | ||||||||
Employment status | x | x | x | ||||||
Sick leave | x | x | x | ||||||
Return to work | x | x | x | ||||||
Index event | x | ||||||||
Clinical measurements | |||||||||
Weight | x | x | x | ||||||
Heart rate | x | x | x | ||||||
Blood pressure | x | x | x | ||||||
ECG | x | x | x | ||||||
Biochemical screening | x | x | x | ||||||
NYHA classification | x | x | x | ||||||
CCS classification | x | x | x | ||||||
Medication | x | x | x | ||||||
Comorbidity | |||||||||
History of heart disease | x | ||||||||
Chronic obstructive pulmonary disease | x | ||||||||
Kidney disease | x | ||||||||
Depression | x | ||||||||
Risk factors | |||||||||
Hypertension | x | ||||||||
Dyslipidaemia | x | ||||||||
Diabetes mellitus | x | x | x | ||||||
Family history | x | ||||||||
Smoking | x | x | x | ||||||
Physical activity | x | x | x | ||||||
Rehabilitation received | x | x | |||||||
Questionnaires | |||||||||
HADS | x | x | x | ||||||
HeartQol | x | x | x | ||||||
Psychosocial status | x | x | x | ||||||
Cardiovascular readmission | x | ||||||||