Table 2 Effect of the THERAD intervention vs control on primary and secondary outcomes: change from baseline to 2, 6 and 12 months (using linear mixed models in modified intention-to-treat population for continuous outcomes, and logistic mixed models in intention-to-treat population for binary outcomes)
Estimated change from baseline meana or ORb (95%CI) | Estimated differences in change from baseline mean or ORb (95%CI) p value | Estimated change from baseline meana or ORb (95%CI) | Estimated differences in change from baseline mean or ORb (95%CI) p value | Estimated change from baseline meana or ORb (95%CI) | Estimated differences in change from baseline mean or ORb (95%CI) p value | ||||
|---|---|---|---|---|---|---|---|---|---|
Outcome | Intervention | Control | Intervention vs Control | Intervention | Control | Intervention vs Control | Intervention | Control | Intervention vs Control |
M2–M0 | M6–M0 | M12–M0 | |||||||
QOL patient by caregiver | 0.77 [− 0.13 to 1.66] | 0.09 [− 0.83 to 1.00] | 0.68 [− 0.60 to 1.96] p = 0.2970 | 0.15 [− 0.65 to 0.94] | − 0.18 [− 0.98 to 0.62] | 0.33 [− 0.80 to 1.46] p = 0.5651 | − 0.78 [− 1.93 to 0.38] | − 0.59 [− 1.78 to 0.61] | − 0.19 [− 1.85 to 1.47] p = 0.8198 |
QOL patient by patient | 0.72 [− 0.44 to 1.88] | − 0.98 [− 2.19 to 0.24] | 1.70 [0.01 to 3.38] p = 0.0483 | 0.96 [0.00 to 1.91] | − 0.78 [− 1.80 to 0.23] | 1.74 [0.34 to 3.15] p = 0.0154 | 1.32 [0.07 to 2.56] | − 0.50 [− 1.89 to 0.89] | 1.82 [− 0.06 to 3.69] p = 0.0575 |
NPI f*g | − 2.52 [− 6.32 to 1.29] | 0.26 [− 3.51 to 4.03] | − 2.77 [− 8.13 to 2.59] p = 0.3090 | − 2.64 [− 5.90 to 0.61] | 1.09 [− 2.18 to 4.35] | − 3.73 [− 8.34 to 0.89] p = 0.1126 | − 2.83 [− 6.89 to 1.23] | 2.33 [− 1.94 to 6.60] | − 5.16 [− 11.05 to 0.73] p = 0.0859 |
ADL | − 0.09 [− 0.20 to 0.02] | − 0.15 [− 0.25 to − 0.04] | 0.06 [− 0.09 to 0.21] p = 0.4519 | − 0.23 [− 0.32 to − 0.13] | − 0.24 [− 0.33 to − 0.15] | 0.02 [− 0.12 to 0.15] p = 0.8150 | − 0.43 [− 0.59 to − 0.27] | − 0.38 [− 0.54 to − 0.23] | − 0.05 [− 0.27 to 0.18] p = 0.6855 |
IADL (≥ 4 vs < 4 incapacities) | 1.60 [1.10 to 2.31] | 1.46 [1.04 to 2.06] | 1.09 [0.69 to 1.72] p = 0.7096 | 4.07 [1.34 to 12.31] | 3.14 [1.13 to 8.69] | 1.30 [0.33 to 5.11] p = 0.7096 | 16.53 [1.80 to 151.63] | 9.83 [1.28 to 75.52] | 1.68 [0.11 to 26.12] p = 0.7096 |
MMSE | − 0.38 [− 0.95 to 0.19] | − 0.76 [− 1.32 to − 0.19] | 0.38 [− 0.43 to 1.18] p = 0.3560 | − 1.08 [− 1.63 to − 0.52] | − 1.07 [− 1.61 to − 0.53] | − 0.01 [− 0.79 to 0.77] p = 0.9825 | − 2.12 [− 2.92 to − 1.32] | − 1.53 [− 2.31 to − 0.76] | − 0.59 [− 1.71 to 0.53] p = 0.3007 |
One leg balance (abnormal vs normal) | 1.00 [0.87 to 1.14] | 1.08 [0.93 to 1.25] | 0.92 [0.76 to 1.13] p = 0.4282 | 0.99 [0.65 to 1.50] | 1.26 [0.82 to 1.94] | 0.79 [0.43 to 1.43] p = 0.4282 | 0.98 [0.42 to 2.25] | 1.58 [0.67 to 3.76] | 0.62 [0.19 to 2.04] p = 0.4282 |
Zarit | − 2.38 [− 4.50 to − 0.25] | − 0.14 [− 2.24 to 1.96] | − 2.24 [− 5.23 to 0.75] p = 0.1411 | − 1.19 [− 3.18 to 0.80] | 0.35 [− 1.62 to 2.31] | − 1.54 [− 4.33 to 1.26] p = 0.2786 | 0.58 [− 2.30 to 3.46] | 1.07 [− 1.79 to 3.92] | − 0.49 [− 4.54 to 3.57] p = 0.8128 |
Mini-GDS (≥ 1 vs =0) | 1.02 [0.86 to 1.22] | 0.89 [0.74 to 1.06] | 1.15 [0.89 to 1.48] p = 0.2759 | 1.06 [0.63 to 1.80] | 0.70 [0.41 to 1.19] | 1.52 [0.71 to 3.22] p = 0.2759 | 1.13 [0.39 to 3.26] | 0.49 [0.17 to 1.43] | 2.30 [0.51 to 10.39] p = 0.2759 |
NHP | − 0.59 [− 14.48 to 13.30] | − 6.38 [− 20.02 to 7.27] | 5.79 [− 13.68 to 25.26] p = 0.5582 | 2.57 [− 11.03 to 16.17] | 1.95 [− 11.34 to 15.23] | 0.62 [− 18.39 to 19.64] p = 0.9484 | 7.31 [− 12.99 to 27.60] | 14.43 [− 5.37 to 34.23] | − 7.12 [− 35.48 to 21.23] p = 0.6199 |