Table 5.
Functional status, health utility, anxiety, quality of life, well-being and satisfaction with treatment at 1 year by study group and between-group differences in the ADDITION-Plus trial
| Measurea | Comparison group | Intervention group | Difference between groups (95% CI)b |
|---|---|---|---|
| SF-36 | |||
| Physical functioning | 73.3 (27.8) | 79.2 (22.5) | 5.89 (1.24, 10.85) |
| Role limitation, physical | 71.7 (40.2) | 76.0 (35.8) | 4.32 (−3.06, 11.29) |
| Role limitation, emotional | 84.4 (32.2) | 80.7 (34.2) | −3.69 (−9.98, 1.99) |
| Social functioning | 83.6 (25.3) | 85.1 (23.9) | 1.51 (−2.93, 6.02) |
| Mental health | 76.3 (19.4) | 76.5 (17.3) | 0.15 (−3.25, 3.32) |
| Energy/vitality | 56.5 (24.0) | 59.4 (20.8) | 2.97 (−1.11, 7.21) |
| Pain | 71.6 (27.3) | 73.1 (25.2) | 1.50 (−3.28, 6.37) |
| General health perception | 59.7 (23.4) | 61.2 (20.6) | 1.46 (−2.98, 5.51) |
| Change in health | 55.4 (20.9) | 64.1 (22.7) | 8.72 (4.57, 12.74) |
| Health utility | |||
| Self-reported general health (1 to 5) | 2.94 (0.92) | 3.11 (0.87) | 0.19 (0.07, 0.31)c |
| EQ-5D (−0.3 to 1.0) | 0.81 (0.26) | 0.84 (0.20) | 0.03 (0.003, 0.06)c |
| Anxiety | |||
| Spielberger State Anxiety (20 to 80) | 30.5 (11.0) | 29.6 (9.6) | −0.85 (−2.56, 0.85)c |
| Quality of life and well-being | |||
| Quality of life (−9 to 9) | 0.96 (1.28) | 0.79 (1.05) | −0.17 (−0.38, 0.06) |
| Diabetes-specific well-being (0 to 36) | 28.2 (6.6) | 28.8 (6.3) | 0.61 (−0.70, 1.76) |
| General well-being (0 to 36) | 26.4 (7.2) | 26.9 (6.5) | 0.47 (−0.80, 1.81) |
| Satisfaction with treatment, services and empathy | |||
| Diabetes treatment satisfaction (0 to 36) | 30.0 (5.8) | 30.6 (5.3) | 0.59 (−0.41, 1.72) |
| General practitioner CARE measure (10 to 50) | 39.1 (10.2) | 40.3 (9.5) | 1.23 (−0.64, 3.17) |
| Nurse CARE measure (10 to 50) | 39.8 (9.8) | 40.9 (9.1) | 1.14 (−0.78, 2.89) |
| Satisfaction with diabetes services (1 to 4) | 3.43 (0.79) | 3.68 (0.56) | 0.25 (0.13, 0.38) |
Values are mean (SD) unless stated
aValues in parentheses represent the possible range for each measure
bModel residuals showed non-normality, which could not be resolved after log-transformation. Therefore, 95% CIs were calculated using the semi-parametric bias corrected and accelerated bootstrap regression method (with 1,999 resamples)
cDifference between groups is adjusted for baseline values