# 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
1. Model 1: linear mixed model adjusted on baseline data
2. Model 2: linear mixed model with baseline value included in the dependent variable
3. a Mean (95%CI): estimated with the mean values at baseline for model 1 