Table 3.
Clinical Measures at baseline, 6, and 12 weeks by allocation group.
| Scale and visit | CareLoop enhanced monitoring, mean (SD) | Management as Usual, mean (SD) | Adjusted mean differencea | 95% CI | P value | P value | Intercept site*trial arm P | |
|
|
|
|
|
|
2-tailed | 1-tailed |
|
|
| PANSSb Total | ||||||||
|
|
Baseline | 72.9 (14.8) | 76.8 (17.4) |
|
|
|
|
|
|
|
Weeks 6 | 70.7 (17.0) | 73.9 (20.7) | –0.47 | –6.47 to 5.53 | .874 | .44 | .46 |
|
|
Week 12 | 64.5 (15.7) | 69.3 (20.7) | –1.93 | –7.50 to 3.64 | .492 | .25 | .003 |
| PANSS Positive | ||||||||
|
|
Baseline | 18.8 (5.4) | 18.3 (5.7) |
|
|
|
|
|
|
|
Weeks 6 | 17.3 (6.2) | 17 (6.2) | –0.37 | –2.35 to 1.60 | .708 | .35 | .34 |
|
|
Week 12 | 16 (5.3) | 16.7 (6.2) | –1.13 | –3.12 to .87 | .264 | .13 | .057 |
| PANSS Negative | ||||||||
|
|
Baseline | 18.8 (4.3) | 18.3 (5.5) |
|
|
|
|
|
|
|
Weeks 6 | 16.1 (4.4) | 18.2 (5.7) | –0.44 | –2.18 to 1.30 | .616 | .31 | .75 |
|
|
Week 12 | 15 (4.4) | 17.1 (5.6) | –0.69 | –2.51 to 1.15 | .462 | .23 | .53 |
| PANSS General | ||||||||
|
|
Baseline | 38.2 (8.7) | 40 (9.2) |
|
|
|
|
|
|
|
Weeks 6 | 37.4 (9.5) | 38.7 (10.9) | –0.17 | –3.70 to 3.37 | .994 | .47 | .64 |
|
|
Week 12 | 33.5 (8.6) | 35.5 (10.7) | –0.79 | –3.86 to 2.29 | .611 | .31 | .38 |
| ERSc Total | ||||||||
|
|
Baseline | 86.3 (7.4) | 81.4 (7.8) |
|
|
|
|
|
|
|
Weeks 6 | 85.4 (7.6) | 81.6 (10.3) | 0.58 | –2.99 to 4.15 | .748 | .37 | .47 |
|
|
Week 12 | 86.5 (11.9) | 83.6 (8.1) | –0.05 | –4.35 to 4.25 | .983 | .49 | .32 |
| EQ5Dd Total | ||||||||
|
|
Baseline | 8.8 (3.1) | 9.6 (4.1) |
|
|
|
|
|
|
|
Weeks 6 | 9.2 (3.4) | 8.8 (4.2) | –0.29 | –2.43 to 1.85 | .286 | .14 | .29 |
|
|
Week 12 | 8.0 to 4.1 | 8.4 (3.8) | 0.15 | –1.23 to 1.53 | .812 | .41 | .15 |
| CDSe Total | ||||||||
|
|
Baseline | 5.8 to 4.6 | 8.1 (5.6) |
|
|
|
|
|
|
|
Weeks 6 | 6 to 4.5 | 7.3 (5.2) | 0.29 | –1.30 to 1.90 | .712 | .36 | .03 |
|
|
Week 12 | 4.6 to 3.7 | 6.5 (4.8) | –0.67 | –2.24 to 0.90 | .4 | .20 | .83 |
| GAFf | ||||||||
|
|
Baseline | 49.7 to 14.9 | 49.3 (11.8) |
|
|
|
|
|
|
|
Weeks 6 | 49.2 to 14.5 | 47.7 (16.7) | –0.62 | –6.45 to 5.21 | .595 | .23 | .90 |
|
|
Week 12 | 51.8 to 13.7 | 52.2 (16.2) | –2.65 | –8.38 to 3.07 | .850 | .43 | .30 |
aFollow-up differences adjusted for baseline scores and the main effect of site.
bPANSS: Positive and Negative Syndrome Scale
cERS: Empowerment Rating Scale
dEQ5D: EuroQol-5D
eCDS: Calgary Depression Scale
fGAF: Global Assessment of Functioning