Table 2.
Primary and Secondary Outcomes
| Outcomes | NC | MCI | ||||
|---|---|---|---|---|---|---|
| A.Primary outcome—treatment effect at 6 months using those who completed in-home assessment before COVID-19 pandemic (prepandemic cohort) based on linear regression model under modified ITTa | NC (n = 25) Con/Exp = 15/10 |
MCI (n = 31) Con/Exp = 18/13 |
||||
| Estimate | SE | p Value | Estimate | SE | p Value | |
| Total MoCA score (reference: control group). | 0.14 | 0.86 | .87 | 1.75 | .76 | 0.03 |
| Sensitivity analysis based on multiple imputations | NC (N = 66) Con/Exp = 35/31 |
MCI (N = 74) Con/Exp = 41/33 |
||||
|---|---|---|---|---|---|---|
| Total MoCA Score (imputed missed items in telephone MoCA) (reference: control group) | 0.70 | 0.47 | .14 | 1.17 | .56 | 0.03 |
| B.Secondary outcomes—ITT using all randomized participants, based on MMRMb | NC (n = 86) Con/Exp = 43/43 |
MCI (n = 100) Con/Exp = 49/51 |
||||
|---|---|---|---|---|---|---|
| Estimate | SE | p Value | Estimate | SE | p Value | |
| Category fluency (Animal naming) | ||||||
| COVID-19 | 0.15 | 0.71 | .83 | 0.19 | 0.63 | .44 |
| Group × 6 months | 2.56 | 1.19 | .03 | 0.69 | 0.93 | .46 |
| Group × 12 months | 1.10 | 1.29 | .40 | 1.14 | 1.31 | .39 |
| Craft Story (Immediate recall) (Paraphrase scoring) | ||||||
| COVID-19 | -0.47 | 0.50 | .36 | -1.05 | 0.54 | .05 |
| Group × 6 months | -0.63 | 0.82 | .45 | -0.66 | 0.80 | .41 |
| Group × 12 months | 0.62 | 1.02 | .55 | 2.19 | 1.05 | .04 |
| Craft Story (Delayed recall) (Paraphrase scoring) | ||||||
| COVID-19 | -0.84 | 0.52 | .11 | -1.07 | 0.55 | .06 |
| Group × 6 months | -0.26 | 0.77 | .74 | -0.10 | 0.79 | .90 |
| Group × 12 months | 0.10 | 1.00 | .92 | 1.64 | 1.10 | .14 |
Notes: Con = Control Group; Exp = Experimental Group; COVID = coronavirus disease; COVID-19 = coronavirus disease 2019; MCI = participants with mild cognitive impairment; NC = participants with normal cognition; MoCA = Montreal Cognitive Assessment; SE = standard error. The results with p-value ≤ 0.05 were bolded.
aITT: intention to treat. Each outcome was modeled separately. The full model included baseline cognitive test score and the group allocation.
bMMRM: Mixed Model for Repeated Measures. Each outcome was modeled separately. Group: experimental group (control group as a reference). The full model included cognitive status (MCI vs normal), a COVID pandemic indicator (pre- vs post-COVID outbreak), group, time, and group by time interaction. For secondary outcomes (B), multiple comparison adjusted p value is .016.