Table 1.
Measures | Intervention periods, mean (SD) | Control periods, mean (SD) | Mean difference (95% CI) | P value | ||||||
Adherence outcomes |
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Pill-count assessmenta | 0.58 (0.38) | 0.48 (0.35) | 0.11 (0.04, 0.19) | .004 | |||||
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Other |
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Medication refill assessment | 0.77 (0.35) | 0.76 (0.34) | –0.01 (–0.06, 0.04) | .70 | ||||
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DAI-10b | 0.67 (0.23) | 0.67 (0.22) | 0.01 (–0.04, 0.06) | .73 | ||||
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BARSc | 0.71 (0.20) | 0.68 (0.23) | 0.04 (–0.01, 0.08) | .13 | ||||
Secondary outcomes |
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WHOd DASa,e | 0.15 (0.19) | 0.15 (0.19) | 0.02 (–0.01, 0.06) | .19 | |||||
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CGIf severity of illnessa,g | 2.51 (1.23) | 2.76 (1.24) | –0.26 (–0.50, 0.02) | .04 | |||||
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Negative | 2.41 (1.17) | 2.98 (1.43) | –0.47 (–0.76, 0.19) | .001 | ||||
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Positive | 2.42 (1.19) | 2.67 (1.55) | –0.47 (–0.76, 0.17) | .002 | ||||
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Depression | 1.9 (1.01) | 2.11 (1.26) | –0.21 (–0.44, 0.01) | .07 | ||||
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Cognition | 2.44 (1.19) | 2.85 (1.44) | –0.50 (–0.79, 0.21) | <.001 | ||||
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CGI degree of changea,h | 3.12 (1.16) | 3.02 (1.08) | 0.10 (0.00, 0.25) | .05 | |||||
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686 Program |
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Rehospitalization due to schizophrenia | 43 (11.1) | 25 (19.5) | 0.58 (0.37, 0.91) | .02 | ||||
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Deathi | 0 (1.0) | 3 (2.2) | N/A | N/A | ||||
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Suicidei | 0 (0.0) | 1 (0.0) | N/A | N/A | ||||
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Wandering | 7 (1.7) | 2 (1.5) | 0.98 (0.23, 4.13) | .98 | ||||
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Hurting people or smashing objects | 2 (0.4) | 6 (4.5) | 0.11 (0.02, 0.54) | .006 | ||||
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Getting into trouble | 0 (0.0) | 0 (0.0) | 0.11 (0.04, 0.19) | N/A | ||||
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Self-harm | 0 (0.0) | 0 (0.0) | –0.01 (–0.06, 0.04) | N/A |
aAdjusted for baseline covariates with imputation for missing data.
bDAI: Drug Attitude Inventory. The score was rescaled as 0 to 1.
cBARS: Brief Adherence Rating Scale.
dWHO: World Health Organization.
eDAS: Disability Assessment Schedule (range 0 to 1).
fCGI: Clinical Global Impression.
gHigher scores indicate worse symptoms (range 1 to 7).
hHigher scores indicate less change (range 1 to 7).
iThe numbers are for phase 3 only.