Table 2.
Cousineau perceived burden scores over time
| Time Point | Three Times per Week | Six Times per Week | Between-Group Differencea | P Value |
|---|---|---|---|---|
| Daily Trial | ||||
| Baseline | 37.7±23.0 | 37.1±27.6 | ||
| Month 4 | 35.0±22.7 | 32.9±25.1 | ||
| Change from baseline | −1.1±2.8 | −2.7±2.5 | −1.6 (−8.4 to 5.2) | 0.64 |
| Change (imputed) | 1.8±4.3 | 0.6±4.1 | −1.2 (−8.0 to 5.6) | 0.73 |
| Month 12 | 31.2 ±21.9 | 30.1±22.9 | ||
| Change from baseline | −2.6±3.1 | −4.7±2.7 | −2.1 (−9.4 to 5.3) | 0.58 |
| Change (imputed) | 1.2±4.7 | −1.5±4.4 | −2.7 (−9.8 to 4.4) | 0.46 |
| Nocturnal Trial | ||||
| Baseline | 32.9±18.3 | 32.0±19.7 | ||
| Month 4 | 32.0±16.9 | 41.1±18.5 | ||
| Change from baseline | −0.3±2.6 | +5.9±2.8 | +6.2 (−0.8 to 13.3) | 0.08 |
| Change (imputed) | −0.3±2.8 | +9.6±3.0 | +9.8 (2.4 to 17.3) | 0.01 |
| Month 12 | 26.9±15.3 | 33.9±22.0 | ||
| Change from baseline | −5.7±2.7 | +0.5±2.7 | +6.1 (−0.8 to 13.1) | 0.08 |
| Change (imputed) | −5.4±3.1 | +4.0±3.4 | +9.4 (0.6 to 18.3) | 0.04 |
Values at baseline, 4 months postrandomization, and 12 months postrandomization are observed means±SDs. Changes from baseline are adjusted means (presented as means±SEM).
a
Treatment effect of six times per week minus three times per week (presented with 95% confidence intervals).