Table 2.
Baseline and four week data for primary and secondary outcomes
| Outcomes | Control | Intervention | Difference (95% CI) | P value | ||
|---|---|---|---|---|---|---|
| nc | Mean (SE) | nc | Mean (SE) | |||
| Primary outcomes | ||||||
| Baseline | ||||||
| NHLSD | 121 | 0 (0) | 119 | 0 (0) | _ | _ |
| Quality of life | ||||||
| DEMQOL sum score | 50 | 86.5 (1.2) | 40 | 86.2 (4.4) | 0.30 (−3.4, 4.0) | 0.8711 |
| DEMQOL index (utility) | 50 | 0.80 (0.04) | 40 | 0.79 (0.04) | 0.01 (−0.11, 0.13) | 0.8587 |
| DEMQOL-proxy sum score | 119 | 90.9 (1.0) | 118 | 92.1 (1.0) | −1.1 (−3.8, 1.6) | 0.4141 |
| DEMQOL-proxy index (utility) | 119 | 0.62 (0.02) | 118 | 0.54 (0.02) | −0.01 (−0.08, 0.06) | 0.7111 |
| EQ5D5L index (utility) | 119 | 0.22 (0.02) | 119 | 0.23 (0.02) | −0.01 (−0.08, 0.06) | 0.7788 |
| 4 Weeks | ||||||
| NHLSD | 96 | 6.3 (0.50) | 107 | 8.2 (0.47) | −1.9 (−3.3, −0.57) | 0.0055 |
| Quality of life | ||||||
| DEMQOL sum score | 45 | 88.3 (1.6) | 49 | 91.0 (1.7) | −2.7 (−7.3, 1.8) | 0.2370 |
| DEMQOL index | 67 | 0.68 (0.05) | 59 | 0.74 (0.04) | −0.06 (−0.20, 0.08) | 0.3896 |
| DEMQOL-proxy sum score | 94 | 93.7 (1.1) | 105 | 94.2 (1.0) | −0.52 (−3.5, 2.4) | 0.7305 |
| DEMQOL-proxy index | 116 | 0.54 (0.02) | 115 | 0.60 (0.02) | −0.06 (−0.11, 0.01) | 0.0784 |
| EQ5D5L index | 118 | 0.38 (0.02) | 115 | 0.43 (0.02) | −0.05 (−0.12, 0.01) | 0.1058 |
| 12 Months | ||||||
| NHLSD | 66 | 10.1 (0.60) | 60 | 10.5 (0.63) | 0.37 (−2.1, 1.3) | 0.6777 |
| Quality of life | ||||||
| DEMQOL sum score | 41 | 88.5 (1.6) | 29 | 95.9 (2.0) | −7.4 (−12.5, −2.3) | 0.0051 |
| DEMQOL index | 93 | 0.54 (0.03) | 87 | 0.48 (0.04) | 0.06 (−0.07, 0.19) | 0.3521 |
| DEMQOL-proxy sum score | 66 | 101.9 (1.3) | 60 | 98.7 (1.4) | 3.1 (−0.62, 6.9) | 0.1023 |
| DEMQOL-proxy index | 118 | 0.40 (0.02) | 118 | 0.34 (0.02) | 0.06 (−0.003, 0.13) | 0.0628 |
| EQ5D5L index | 118 | 0.30 (0.02) | 117 | 0.24 (0.02) | 0.06 (−0.006, 0.13) | 0.0739 |
| Secondary outcomes | ||||||
| Baseline | ||||||
| PAINAD | 121 | 1.4 (0.11) | 119 | 1.4 (0.11) | 0.00 (−0.31, 0.31) | 0.9824 |
| Modified Barthel Index | 121 | 9.6 (1.8) | 119 | 9.5 (1.8) | 0.08 (−4.9, 5.1) | 0.9735 |
| Cornell Scale for Depression in Dementia | 119 | 10.1 (0.42) | 119 | 10.0 (0.42) | 0.01 (−1.2, 1.2) | 0.9857 |
| Mini-Nutritional Assessment | 121 | 5.4 (0.20) | 119 | 5.3 (0.20) | 0.12 (−0.43, 0.68) | 0.6670 |
| Functional recovery | 121 | 1.8 (0.36) | 119 | 1.8 (0.36) | 0.01 (−0.98, 1.01) | 0.9798 |
| Delirium | 121 | 0.34 (0.04)a | 119 | 0.35 (0.04)a | 0.94 (0.55, 1.6)b | 0.8184 |
| 4 Weeks | ||||||
| PAINAD | 95 | 0.49 (0.13) | 107 | 0.51 (0.12) | −0.02 (−0.34, 0.29) | 0.8998 |
| Modified Barthel Index | 95 | 23.5 (2.0) | 107 | 24.4 (1.9) | −1.0 (−6.4, 4.5) | 0.7267 |
| Cornell Scale for Depression in Dementia | 96 | 10.6 (0.47) | 107 | 10.5 (0.44) | 0.15 (−1.1, 1.4) | 0.8097 |
| Mini-Nutritional Assessment | 96 | 6.2 (0.22) | 107 | 6.9 (0.21) | −0.65 (−1.3, −0.05) | 0.0338 |
| Functional recovery | 94 | 5.8 (0.40) | 107 | 6.0 (0.38) | −0.25 (−1.3, 0.84) | 0.6542 |
| Delirium | 95 | 0.13 (0.03) | 107 | 0.17 (0.04) | 0.75 (0.35, 1.6) | 0.4589 |
| 12 Months | ||||||
| PAINAD | 66 | 0.06 (0.15) | 60 | 0.05 (0.16) | 0.01 (−0.42, 0.44) | 0.9645 |
| Modified Barthel Index | 66 | 32.3 (2.4) | 59 | 27.4 (2.5) | 5.0 (−1.9, 11.8) | 0.1533 |
| Cornell Scale for Depression in Dementia | 66 | 9.3 (0.56) | 60 | 10.1 (0.59) | −0.8 (−2.4, 0.8) | 0.3262 |
| Mini-Nutritional Assessment | 66 | 8.0 (0.27) | 60 | 8.8 (0.28) | −0.73 (−1.5, 0.03) | 0.0592 |
| Functional recovery | 66 | 7.1 (0.48) | 60 | 6.2 (0.50) | 0.84 (−0.52, 2.2) | 0.2257 |
| Delirium | 66 | 0.18 (0.05)a | 60 | 0.22 (0.05)a | 0.77 (0.33, 1.8)b | 0.5486 |
aPercentage.
bodds ratio.
cFor sum scores, deceased patients were treated as missing, for index scores (utility), patients who were deceased were assigned a zero value.