Table 6.
Primary and safety outcomes at 16 and 32 weeks of follow-up stratified by neuropsychiatric symptoms, QoL and systolic blood pressure at baseline by intention-to-treat analysis
| Mean between-group differences of change between baseline and follow-up (95% CI) | Hazard ratio (95% CI) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Outcome NPI-NH | Outcome Qualidem (LT) | All-cause SAE | All-cause mortality | ||||||||||
| n | Adjusteda | P a | n | Adjusteda | P a | n | Unadjusted | P | n | Unadjusted | P | ||
| 16 weeks | |||||||||||||
| Overall | |||||||||||||
| 177 | 1.6 (−2.3 to 5.6) | 0.42 | 177 | −2.5 (−6.0 to 1.0) | 0.15 | 205 | 1.27 (0.63 to 2.57) | 0.51 | 205 | 1.39 (0.66 to 2.95) | 0.39 | ||
| NPI-NH | |||||||||||||
| ≤12 | 88 | −1.9 (−5.3 to 1.6) | 0.29 | 88 | 2.1 (−2.2 to 6.4) | 0.34 | 103 | 1.30 (0.47 to 3.59) | 0.61 | 103 | 1.52 (0.53 to 4.37) | 0.44 | |
| >12 | 89 | 5.7 (−1.4 to 12.8) | 0.12 | 89 | −7.2 (−12.4 to −2.1) | 0.0070 | 102 | 1.23 (0.46 to 3.30) | 0.68 | 102 | 1.28 (0.44 to 3.68) | 0.65 | |
| Qualidem (LT) | |||||||||||||
| <70 | 90 | 3.6 (−3.5 to 10.8) | 0.32 | 90 | −4.1 (−10.0 to 1.7) | 0.16 | 102 | 1.07 (0.39 to 2.96) | 0.89 | 102 | 1.32 (0.42 to 4.15) | 0.64 | |
| ≥70 | 87 | −0.7 (−4.1 to 2.6) | 0.68 | 87 | −0.5 (−4.2 to 3.2) | 0.79 | 103 | 1.52 (0.57 to 4.09) | 0.40 | 103 | 1.52 (0.57 to 4.09) | 0.40 | |
| SBP | |||||||||||||
| <134 | 93 | −3.5 (−8.9 to 1.9) | 0.20 | 93 | 1.2 (−3.4 to 5.8) | 0.60 | 106 | 3.24 (0.88 to 11.98) | 0.078 | 106 | 3.24 (0.88 to 11.98) | 0.078 | |
| ≥134 | 84 | 7.4 (1.7 to 13.2) | 0.011 | 84 | −6.6 (−12.0 to −1.3) | 0.015 | 99 | 0.72 (0.29 to 1.79) | 0.48 | 99 | 0.77 (0.29 to 2.07) | 0.61 | |
| 32 weeks | |||||||||||||
| Overall | |||||||||||||
| 118 | 6.2 (1.9 to 10.6) | 0.0050 | 117 | −3.5 (−8.1 to 1.1) | 0.13 | 205 | 1.50 (0.90 to 2.52) | 0.12 | 205 | 1.50 (0.88 to 2.57) | 0.14 | ||
| NPI-NH | |||||||||||||
| ≤12 | 56 | 3.3 (−0.7 to 7.3) | 0.10 | 55 | −1.2 (−7.3 to 5.0) | 0.71 | 103 | 1.27 (0.58 to 2.79) | 0.55 | 103 | 1.29 (0.57 to 2.92) | 0.54 | |
| >12 | 62 | 8.9 (1.3 to 16.5) | 0.022 | 62 | −5.4 (−12.3 to 1.5) | 0.12 | 102 | 1.67 (0.84 to 3.32) | 0.15 | 102 | 1.65 (0.81 to 3.38) | 0.17 | |
| Qualidem (LT) | |||||||||||||
| <70 | 63 | 9.9 (2.5 to 17.4) | 0.010 | 62 | −2.8 (−9.8 to 4.2) | 0.42 | 102 | 1.55 (0.78 to 3.10) | 0.21 | 102 | 1.70 (0.81 to 3.57) | 0.16 | |
| ≥70 | 55 | 2.0 (−2.1 to 6.2) | 0.33 | 55 | −3.7 (−9.3 to 1.9) | 0.19 | 103 | 1.45 (0.67 to 3.14) | 0.34 | 103 | 1.34 (0.61 to 2.93) | 0.47 | |
| SBP | |||||||||||||
| <134 | 62 | 6.7 (0.4 to 13.0) | 0.038 | 61 | −1.0 (−7.5 to 5.4) | 0.75 | 106 | 2.05 (1.00 to 4.20) | 0.050 | 106 | 1.93 (0.94 to 3.99) | 0.074 | |
| ≥134 | 56 | 6.0 (−0.5 to 12.5) | 0.069 | 56 | −5.6 (−12.6 to 1.3) | 0.11 | 99 | 1.11 (0.53 to 2.33) | 0.79 | 99 | 1.16 (0.52 to 2.58) | 0.73 | |
CI, confidence interval; LT, linearly transformed; NPI-NH, Neuropsychiatric Inventory Nursing Home; SAE, serious adverse event. SBP, systolic blood pressure.
aAdjusted for prespecified factors: baseline value of the investigated outcome, baseline NPI-NH score (binary, ≤12 vs >12) and long-term care organisation.