Table 4.
Mixed effects model results for outcome measures at 6, 12, 18 and 24 months*
| visit | Predicted Mean (95% CI) | Between-Group Difference |
95% CI of Difference |
P- value |
||
|---|---|---|---|---|---|---|
| Intervention | Usual care | |||||
| ADCS Group ADL Inventory | 6 Months | 45.49 (41.02 to 49.96) | 43.57 (38.97 to 48.18) | 1.92 | −3.49 to 7.32 | 0.49 |
| 12 Months | 43.25 (38.33 to 48.17) | 39.36 (34.33 to 44.39) | 3.89 | −2.24 to 10.01 | 0.21 | |
| 18 Months | 39.10 (33.96 to 44.24) | 36.32 (31.06 to 41.58) | 2.78 | −3.71 to 9.27 | 0.40 | |
| 24 Months | 34.47 (28.60 to 40.34) | 32.13 (26.17 to 38.08) | 2.34 | −5.27 to 9.96 | 0.54 | |
| SPPB Total | 6 Months | 3.88 (3.08 to 4.68) | 4.08 (3.25 to 4.91) | −0.20 | −1.19 to 0.78 | 0.68 |
| 12 Months | 3.88 (3.04 to 4.72) | 3.75 (2.88 to 4.61) | 0.14 | −0.91 to 1.18 | 0.80 | |
| 18 Months | 3.52 (2.65 to 4.38) | 3.16 (2.26 to 4.05) | 0.36 | −0.72 to 1.45 | 0.51 | |
| 24 Months | 2.45 (1.55 to 3.35) | 2.78 (1.87 to 3.69) | −0.33 | −1.46 to 0.80 | 0.57 | |
| SPSM Total | 6 Months | 1.85 (1.00 to 2.70) | 2.87 (1.98 to 3.76) | −1.02 | −2.05 to 0.02 | 0.05 |
| 12 Months | 2.00 (1.13 to 2.87) | 2.26 (1.35 to 3.16) | −0.25 | −1.32 to 0.82 | 0.64 | |
| 18 Months | 1.63 (0.72 to 2.53) | 2.06 (1.11 to 3.00) | −0.43 | −1.56 to 0.70 | 0.45 | |
| 24 Months | 1.48 (0.56 to 2.41) | 2.11 (1.15 to 3.07) | −0.62 | −1.78 to 0.53 | 0.29 | |
| NPI Frequency* Severity Score | 6 Months | 13.51 (9.44 to 17.57) | 17.80 (13.58 to 22.02) | −4.29 | −9.31 to 0.73 | 0.09 |
| 12 Months | 13.99 (9.66 to 18.31) | 18.29 (13.88 to 22.71) | −4.31 | −9.71 to 1.09 | 0.12 | |
| 18 Months | 14.96 (10.75 to 19.17) | 15.66 (11.30 to 20.02) | −0.71 | −5.96 to 4.55 | 0.79 | |
| 24 Months | 14.68 (9.97 to 19.38) | 19.13 (14.35 to 23.90) | −4.45 | −10.4 to 1.54 | 0.14 | |
| PHQ-9 Total | 6 Months | 3.48 (2.56 to 4.40) | 4.07 (3.11 to 5.03) | −0.59 | −1.73 to 0.56 | 0.31 |
| 12 Months | 3.65 (2.68 to 4.61) | 4.79 (3.80 to 5.78) | −1.14 | −2.34 to 0.06 | 0.06 | |
| 18 Months | 3.80 (2.81 to 4.79) | 3.83 (2.80 to 4.85) | −0.03 | −1.28 to 1.23 | 0.97 | |
| 24 Months | 3.72 (2.78 to 4.67) | 3.70 (2.73 to 4.67) | 0.02 | −1.15 to 1.20 | 0.97 | |
| GAD-7 Total | 6 Months | 3.22 (2.19 to 4.24) | 3.37 (2.30 to 4.43) | −0.15 | −1.42 to 1.12 | 0.82 |
| 12 Months | 3.21 (2.14 to 4.28) | 4.16 (3.07 to 5.26) | −0.95 | −2.29 to 0.39 | 0.16 | |
| 18 Months | 3.46 (2.48 to 4.44) | 2.75 (1.73 to 3.77) | 0.71 | −0.49 to 1.92 | 0.25 | |
| 24 Months | 2.86 (1.87 to 3.85) | 2.84 (1.83 to 3.86) | 0.01 | −1.20 to 1.23 | 0.98 | |
*
Results included predicted means and 95% confidence intervals from mixed effects models adjusting for randomization strata accounting for repeated assessments over time within the individual
ADCS: Alzheimer’s Disease Cooperative Studies Group; ADL: activities of daily living; SPPB: Short Portable Performance Battery; SPSM: Short Portable Sarcopenia Measure; NPI: Neuropsychiatric Inventory; PHQ-9: Patient Health Questionnaire 9 item depression scale; GAD-7: Generalized Anxiety Disorder 7 item scale.