Table 3.
Time and assessment | Enrolment | Treatment period following randomization | Study end | |||
---|---|---|---|---|---|---|
At randomization | Every 3 months | 3 months | 1 year | 2 year | ||
Eligibility screen, informed consent, allocation to treatment group, and collection of baseline dataa | x | |||||
Self-reported questionnaires on quality of life and symptom burdenb | x | x | x | x | ||
Risk factor control and benefit from cardiac rehabilitationc | x | |||||
Adherence to treatment groupd | x | x | ||||
Information on hospital admissionse | x | x | ||||
Endpoints from registry data | x |
a Data collected during hospital admission or at subsequent visit
b The following e-questionnaires on patient-reported outcomes will be administered: EQ5D, HADS, IIEF/FSFI (short versions), Bergen Insomnia Scale, NYHA, CCS, and SAQ (for those reporting symptoms of angina)
c Data on blood pressure, serum lipids, diabetes, HbA1c, and VO2peak before and after rehabilitation through registry linkage to the Danish Heart Rehabilitation Database. The data are available for patients participating in cardiac rehabilitation
d Self-reported continued adherence to treatment group will be gathered every 3 months. By linkage to the National Prescription Register at study end, adherence to treatment group as well as other medications will be assessed
e Every 3 months the patient’s vital status and hospitalizations will be investigated through self-reported questionnaires or review of electronic health records. All hospital admissions will be evaluated for a possible relationship with treatment group. At study end hospital admission or death from a primary or secondary endpoint will be ascertained from the Danish National Patient Register