Table 2 Measures, assessment, expected scaling, and measurement occasions
Outcome | Source and reference | Scaling | Time |
|---|---|---|---|
Primary outcome | |||
Cardiac anxiety | Total score of the German 17-item version of the CAQ [16] | Continuously, 0 to 4 points | T0, T1, T2, T3 |
Secondary outcomes | |||
Fear | Subscale of the German 17-item version of the CAQ [16] | Continuously, 0 to 4 points | T0, T1, T2, T3 |
Avoidance | Subscale of the German 17-item version of the CAQ [16] | Continuously, 0 to 4 points | T0, T1, T2, T3 |
Attention | Subscale of the German 17-item version of the CAQ [16] | Continuously, 0 to 4 points | T0, T1, T2, T3 |
Change in score for cardiac anxiety | Total score of the German 17-item version of the CAQ [16] | Continuously, − 4 to 4 points | T1, T2, T3 |
Decrease in cardiac anxiety by 0.2 points | Total score of the German 17-item version of the CAQ [16] | Binary, yes/no | T1, T2, T3 |
Depression | PHQ-D [25] | Continuously, 0 to 27 points | T0, T1, T2, T3 |
Generalized anxiety | PHQ-D [25] | Continuously, 0 to 21 points | T0, T1, T2, T3 |
Somatization | PHQ-D [25] | Continuously, 0 to 30 points | T0, T1, T2, T3 |
Functional capacity | IRES-24 [26] | Continuously, 0 to 10 points | T0, T1, T2, T3 |
Blood pressure | Clinical examination | Continuously, systolic/diastolic in mmHg | T0, T1 |
Endurance | Clinical examination | Continuously, ergometer performance in watts/kg | T0, T1 |
General health | Visual analog scale of the EQ-5D [27] | Continuously, 0 to 100 points | T0, T1, T2, T3 |
Health-related quality of life | EQ-5D [28] | Continuously, health state of 11111 corresponds to a value of 1 | T0, T1, T2, T3 |
Motivation to change lifestyle | OutCaRe [31] | Binary, certainly or rather yes vs. uncertain or less | T0, T1 |
Weekly physical activity | BSA-F [33] | Continuously, minutes | T0, T1, T2, T3 |
Self-efficacy to exercise | ESES [32] | Continuously, 10 to 40 points | T0, T1, T2, T3 |
Smoking status | Own development | Binary, yes/no | T0, T1, T2, T3 |
Weight | Clinical examination | Continuously, body mass index in kg/m² | T0, T1, T2, T3 |
Self-rated work ability | Work Ability Score [34] | Continuously, 0 to 10 points | T0, T1, T2, T3 |
Sickness absence | Own development | Binary, yes/no | T0, T2, T3 |
Sickness absence duration | Own development | Continuously, cumulative sickness absence in the last 3 or 12 months in weeks | T0, T2, T3 |
Stable return to work | [36] | Binary, yes/no | T2, T3 |
Time to stable return to work | [36] | Continuously, weeks | T2, T3 |
Employment | Own development | Binary, yes/no | T0, T2, T3 |
Disability pension | Own development | Binary, yes/no | T0, T2, T3 |
Capacity for last job | Medical assessment, standardized medical discharge report [37] | Binary, at least six hours per day or less than six hours per day | T1 |
Capacity for other job | Medical assessment, standardized medical discharge report [37] | Binary, at least six hours per day or less than six hours per day | T1 |
Treatments during the rehabilitation program | Standardized medical discharge report [37], coding according to the classification of therapeutic services report [39] | Continuously, minutes or hours | T1 |
Content of the cognitive-behavioral rehabilitation program | [14] | Continuously, 0 to 12 points | T1 |
Consistency of the approach | [14] | Continuously, 0 to 16 points | T1 |
Gain in competence | [14] | Continuously, 0 to 40 points | T1 |
Recommendations for subsequent services | Standardized medical discharge report [37] | Binary, yes/no for 12 subsequent services | T1 |
Utilization of medical and non-medical services | FIMA [40] | Continuously, resource usage in euro | T3 |
Diagnoses | Standardized medical discharge report [37], clinical interview[42] | Nominal | T1 |
Sociodemographic data | Own development | Various (native language, number of children, level of school education, vocational qualification) | T0 |