Table 3 Effect of the THERAD intervention vs control on patient’s QOL caregiver-reported and self-reported: sensitivity analysis in per protocol population and/or with another mixed linear model method
Estimated change from baseline meana (95%CI) | Estimated differences in change from baseline mean (95%CI) p value | Estimated change from baseline meana (95%CI) | Estimated differences in change from baseline mean (95%CI) p value | Estimated change from baseline meana (95%CI) | Estimated differences in change from baseline mean (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 | |||||||
Per-protocol population model 1 | |||||||||
QOL patient by caregiver (int: 1 = 72, ctrl: n = 76) | 0.71 [− 0.23 to 1.65] | 0.10 [− 0.82 to 1.01] | 0.61 [− 0.70 to 1.93] p = 0.3595 | 0.11 [− 0.72 to 0.94] | − 0.17 [− 0.98 to 0.63] | 0.28 [− 0.88 to 1.45] p = 0.6287 | − 0.79 [− 1.96 to 0.38] | − 0.58 [− 1.78 to 0.61] | − 0.21 [− 1.88 to 1.47] p = 0.8086 |
QOL patient by patient (int: n = 56, ctrl: n = 53) | 0.92 [− 0.30 to 2.14] | − 0.94 [− 2.17 to 0.29] | 1.86 [0.13 to 3.60] p = 0.0356 | 1.11 [0.11 to 2.11] | − 0.75 [− 1.78 to 0.28] | 1.86 [0.42 to 3.31] p = 0.0118 | 1.40 [0.14 to 2.66] | − 0.47 [− 1.87 to 0.93] | 1.87 [− 0.02 to 3.76] p = 0.0529 |
Per-protocol population model 2 | |||||||||
QOL patient by caregiver (int: n = 73, ctrl: n = 90) | − 0.18 [− 0.38 to 0.02] | − 0.06 [− 0.26 to 0.15] | − 0.12 [− 0.41 to 0.16] p = 0.4023 | − 0.53 [− 1.14 to 0.07] | − 0.17 [− 0.78 to 0.44] | − 0.36 [− 1.22 to 0.49] p = 0.4023 | − 1.07 [− 2.27 to 0.14] | − 0.34 [− 1.56 to 0.88] | − 0.73 [− 2.45 to 0.99] p = 0.4023 |
QOL patient by patient (int: n = 61, ctrl: n = 67) | 0.21 [− 0.01 to 0.43] | − 0.06 [− 0.31 to 0.18] | 0.28 [− 0.05 to 0.60] p = 0.0953 | 0.64 [− 0.02 to 1.29] | − 0.19 [− 0.92 to 0.53] | 0.83 [− 0.15 to 1.81] p = 0.0953 | 1.27 [− 0.04 to 2.59] | − 0.39 [− 1.84 to 1.06] | 1.66 [− 0.29 to 3.62] p = 0.0953 |
ITT population model 2 | |||||||||
QOL patient by caregiver (int: n = 95, ctrl: n = 90) | − 0.18 [− 0.37 to 0.02] | − 0.06 [− 0.26 to 0.15] | − 0.12 [− 0.40 to 0.16] p = 0.4005 | − 0.53 [− 1.12 to 0.06] | − 0.17 [− 0.78 to 0.44] | − 0.36 [− 1.21 to 0.49] p = 0.4005 | − 1.06 [− 2.24 to 0.12] | − 0.33 [− 1.55 to 0.88] | − 0.72 [− 2.42 to 0.97] p = 0.4005 |
QOL patient by patient (int: n = 78, ctrl: n = 67) | 0.22 [0.00 to 0.43] | − 0.06 [− 0.31 to 0.18] | 0.28 [− 0.04 to 0.61] p = 0.0858 | 0.65 [0.01 to 1.30] | − 0.19 [− 0.92 to 0.53] | 0.85 [− 0.12 to 1.82] p = 0.0858 | 1.31 [0.02 to 2.60] | − 0.39 [− 1.84 to 1.06] | 1.70 [− 0.24 to 3.63] p = 0.0858 |