Table 5.
End points at Month 19
| Intervention (n = 69) | Control (n = 82) | P-value | |
|---|---|---|---|
| Primary outcomes | |||
| SF-36 mental health score, mean (SD) | 58 (22.1) | 58.7 (23.9) | 0.57 |
| SF-36 physical health score, mean (SD) | 52.8 (23.8) | 51.6 (25.5) | 0.58 |
| MLHFQ score, mean (SD) | 33.4 (22.1) | 27.2 (23.3) | 0.74 |
| Secondary outcomes | |||
| NYHA stage, n (%)a | |||
| I | 14 (22.6) | 21 (29.2) | |
| II | 35 (56.5) | 34 (47.2) | 0.73 |
| III | 12 (19.3) | 15 (20.8) | |
| IV | 1 (1.6) | 2 (2.8) | |
| BMI kg/m2, n (%)b | |||
| < 25 | 13 (22) | 29 (40.3) | |
| 25–30 | 25 (42.4) | 33 (45.8) | 0.007 |
| ≥ 30 | 21 (35.6) | 10 (13.9) | |
| Patient adherencec, n (%) | |||
| Good adherence | 23 (37.1) | 32 (42.1) | |
| Minor nonadherence | 35 (56.5) | 42 (55.3) | 0.55 |
| Nonadherence | 4 (6.4) | 2 (2.6) | |
| Mortality, n (%) | 10/115 (8.7) | 15/126 (11.9) | 0.41 |
| Total CHF decompensation/visits (%) | 65/470 (13.8) | 93/545 (17.1) | 0.16 |
| Hospitalisation for CHF decompensation/visits (%) | 18/65 (27.7) | 22/93 (23.7) | 0.57 |
| Hospitalisation not for CHF decompensation/visits (%) | 50/470 (10.6) | 59/545 (10.8) | 0.92 |
| Hospitalisation/visits (%) | 62/470 (13.2) | 74/545 (13.6) | 0.86 |
| Hospitalisation/patients (%) | 41/115 (35.7) | 54/126 (42.9) | 0.26 |
| Total number of days of hospitalisation | 1037 | 867 | |
| HF hospitalisation/patients (%) | 13/115 (11.3) | 17/126 (13.5) | 0.61 |
| Death or hospitalisation/patients (%) | 45/115 (39.1) | 60/126 (47.6) | 0.18 |
| Death or HF hospitalisation/patients (%) | 20/115 (17.3) | 28/126 (22.2) | 0.35 |
| dTotal visits related to GP/patients (%) | 90/115 (78 %) | 106/126(84 %) | 0.24 |
| dNumber of GP visits/patient, mean (SD) | 8.1 (5.3) | 6.4 (4.5) | 0.02 |
| Total visits related to cardiologist/patients (%) | 85/115 (74 %) | 84/126 (67 %) | 0.22 |
| Number of cardiologist visits/patient, mean (SD) | 3.1 (2.2) | 3.1 (2) | 0.92 |
a n = 17 missing data for New York Heart Association stage
b n = 20 missing data for body mass index
c n = 13 missing data for adherence
dAdditional general practitioner visits (in addition to those dedicated to the study)
Significant P-value are in bold