Composite primary outcome | IG | CG | Unadjusted OR (95% CI) § | p-value | Adjusted OR (95% CI) § | p-value |
---|---|---|---|---|---|---|
First non-elective hospital admission or death | n = 307 | n = 272 |  |  |  |  |
ITT analysis (including patients lost to FU as having reached the outcome) | 151 (49.2%) | 102 (37.5%) | 1.7 (1.13–2.54) | 0.01 i | 1.46 (0.99–2.18) | 0.06 iii |
First non-elective hospital admission or death | n = 281 | n = 257 |  |  |  |  |
PP analysis (excluding patients lost to FU: IG n = 26, CG n = 15) | 125 (44.5%) | 87 (33.9%) | 1.57 (1.01–2.43) | 0.04 i | 1.33 (0.87–2.04) | 0.2 iii |
Secondary outcomes | IG | CG | Unadjusted HR (95% CI) § | p-value | Adjusted HR (95% CI) § | p-value |
Mortality | n = 281 §§ | n = 257 §§ |  |  |  |  |
Post-interventional death (all-cause) | 31 (11.0%) | 22 (8.6%) | 1.54 (0.74–3.25) | 0.25 iii | 1.34 (0.62–2.91) | 0.46 iii |
Secondary outcomes | IG | CG | Unadjusted OR (95% CI) § | p-value | Adjusted OR (95% CI) § | p-value |
Mortality | n = 281 §§ | n = 257 §§ |  |  |  |  |
Post-interventional death (all-cause) | 31 (11.0%) | 22 (8.6%) | 1.32 (0.61–2.86) | 0.5 i | 1.18 (0.51–2.72) | 0.7 iii |
Non-elective hospital admissions | n = 281 | n = 257 |  |  |  |  |
Patients with ≥1 hospital admission (%) | 103 (36.7%) | 68 (26.5%) | 1.61 (1.03–2.51) | 0.04 i | 1.39 (0.95–2.03) | 0.09 iii |
Total number of hospital admissions | 122 | 74 | – | – | – | – |
Median (IQR) | 0 (0–1) | 0 (0–1) | – | 0.008 ii | – | – |
Falls | n = 281 | n = 257 |  |  |  |  |
Patients with ≥1 falls (%) | 58 (20.6%) | 73 (28.4%) | 0.66 (0.35–1.21) | 0.2 i | 0.55 (0.31–0.98) | 0.04 iii |
Total number of falls | 65 | 76 | – | – | – | – |
Median (IQR) | 0 (0–0) | 0 (0–1) | – | 0.047 ii | – | – |
Fractures | n = 281 | n = 257 |  |  |  |  |
Patients with ≥1 fractures (%) | 25 (8.9%) | 13 (5.1%) | 1.83 (0.87–3.86) | 0.1 i | 1.61 (0.8–3.2) | 0.2 iii |
Total number of fractures | 26 | 13 | – | – | – | – |
Median (IQR) | 0 (0–0) | 0 (0–0) | – | 0.08 ii | – |  |
Number of drug prescriptions | n = 250 §§ | n = 235 §§ |  | p-value | – | p-value |
Total number of drugs | 2218 | 2140 | – | – | – | – |
Median number of drugs (IQR) | 8 (7–10) | 9 (8–10) | – | 0.1 ii | – | – |
Change in number of drugs from baseline: median reduction (IQR) | 0 (−1–0) | 0 (−2–0) | – | 0.6 ii | – | – |
EQ-5D-5L index | n = 250 | n = 235 |  | p-value | – | p-value |
Median (IQR) | 0.806 (0.698–0.909) | 0.806 (0.701–0.909) | – | 0.3 ii | – | – |
EQ-VAS score | n = 250 | n = 234 |  | p-value | – | p-value |
Median (IQR) | 60 (50–75) | 60 (50–70) | – | 0.2 ii | – | – |
5-GDS: Score ≥ 2 points (affective impairment) | n = 250 | n = 235 |  | p-value | – | p-value |
n patients (%) | 105 (42.0%) | 81 (34.5%) | 1.38 (0.89–2.12) | 0.2 i | 1.41 (0.9–2.21) | 0.1 iii |
6-CIT: Score ≥ 8 points (cognitive impairment) | n = 250 | n = 235 |  | p-value | – | p-value |
n patients (%) | 64 (25.6%) | 61 (26.0%) | 0.98 (0.57–1.7) | 0.9 i | 0.88 (0.48–1.62) | 0.7 iii |