Table 2.
Baseline to 8-Month mixed model estimates of mean change scores by randomization status.
| All Patients (n=302) | Intervention (n=150) | Usual Care (n=152) | Between Group Difference (95% CI) | P |
|---|---|---|---|---|
| SF-36 MCS, mean (SE) | ||||
| Baseline | 43.1 (1.0) | 42.5 (1.0) | ||
| 8-Month follow-up | 50.0 (1.0) | 46.2 (1.1) | ||
| Δ Baseline to 8-Month | 6.8 (1.0) | 3.6 (1.0) | 3.2 (0.5–6.0) | 0.02 |
| HRS-D, mean (SE) | ||||
| Baseline | 16.6 (0.6) | 16.0 (0.6) | ||
| 8-Month follow-up | 9.0 (0.7) | 11.4 (0.7) | ||
| Δ Baseline to 8-Month | 7.6 (0.6) | 4.5 (0.6) | 3.1 (1.3–4.9) | 0.001 |
| SF-36 PCS, mean (SE) | ||||
| Baseline | 31.2 (0.8) | 30.3 (0.8) | ||
| 8-Month follow-up | 44.0 (0.8) | 41.4 (0.8) | ||
| Δ Baseline to 8-Month | 12.8 (0.8) | 11.1 (0.8) | 1.6 (−0.5–3.8) | 0.14 |
| DASI, mean (SE) | ||||
| Baseline | 7.1 (0.9) | 7.9 (0.9) | ||
| 8-Month Follow-up | 25.2 (1.0) | 21.4 (1.0) | ||
| Δ Baseline to 8-Month | 18.1 (1.0) | 13.5 (1.0) | 4.6 (1.9–7.3) | 0.001 |
| Men (n=177) | Intervention (n=81) | Usual Care (n=96) | ||
| SF-36 MCS, mean (SE) | ||||
| Baseline | 44.3 (1.3) | 43.3 (1.2) | ||
| 8-Month follow-up | 52.1 (1.4) | 45.4 (1.3) | ||
| Δ Baseline to 8-Month | 7.8 (1.3) | 2.1 (1.2) | 5.7 (2.2–9.2) | 0.001 |
| HRS-D, mean (SE) | ||||
| Baseline | 15.7 (0.8) | 15.8 (0.8) | ||
| 8-Month follow-up | 7.8 (0.9) | 10.9 (0.8) | ||
| Δ Baseline to 8-Month | 7.9 (0.8) | 4.9 (0.8) | 3.0 (0.8–5.3) | 0.009 |
| SF-36 PCS, mean (SE) | ||||
| Baseline | 31.9 (1.0) | 30.0 (1.0) | ||
| 8-Month follow-up | 46.6 (1.1) | 41.0 (1.0) | ||
| Δ Baseline to 8-Month | 14.6 (1.0) | 11.1 (1.0) | 3.6 (0.8–6.3) | 0.01 |
| DASI, mean (SE) | ||||
| Baseline | 7.5 (1.2) | 7.3 (1.1) | ||
| 8-Month Follow-up | 29.3 (1.3) | 22.9 (1.2) | ||
| Δ Baseline to 8-Month | 21.8 (1.3) | 15.6 (1.2) | 6.1 (2.7–9.6) | 0.001 |
| Women (n=125) | Intervention (n=69) | Usual Care (n=56) | ||
| SF-36 MCS, mean (SE) | ||||
| Baseline | 42.0 (1.4) | 41.7 (1.6) | ||
| 8-Month follow-up | 47.8 (1.6) | 46.9 (1.7) | ||
| Δ Baseline to 8-Month | 5.9 (1.5) | 5.1 (1.6) | 0.7 (−3.3–4.9) | 0.74 |
| HRS-D, mean (SE) | ||||
| Baseline | 17.6 (0.9) | 16.2 (1.0) | ||
| 8-Month follow-up | 10.2 (1.0) | 12.0 (1.1) | ||
| Δ Baseline to 8-Month | 7.4 (0.9) | 4.2 (1.0) | 3.2 (0.5–5.9) | 0.02 |
| SF-36 PCS, mean (SE) | ||||
| Baseline | 30.5 (1.1) | 30.6 (1.2) | ||
| 8-Month follow-up | 41.4 (1.2) | 41.8 (1.3) | ||
| Δ Baseline to 8-Month | 10.9 (1.2) | 11.2 (1.3) | −0.3 (−3.6–3.0) | 0.86 |
| DASI, mean (SE) | ||||
| Baseline | 6.6 (1.3) | 8.5 (1.5) | ||
| 8-Month follow-up | 21.1 (1.4) | 19.9 (1.6) | ||
| Δ Baseline to 8-Month | 14.5 (1.4) | 11.4 (1.6) | 3.1 (−1.1–7.3) | 0.14 |
SE indicates standard error; CI confidence interval