Table 7.
Outcome descriptive statistics and effect estimates (mean difference from a three-level random intercept linear regression model) with 95% Confidence intervals for HARPdoc vs BGAT for secondary endpoint data: mental health questionnaires (Diabetes Distress (PAID); Hospital Anxiety and Depression scores (HADS-A and HADS-D)).
| HARPdoc baseline | BGAT baseline | HARPdoc 12 month | BGAT 12 month | Estimated mean difference [95% CI] | p | HARPdoc 24 month | BGAT 24 month | Estimated mean difference [95% CI] | p | |
|---|---|---|---|---|---|---|---|---|---|---|
| PAID, Total score | N = 46 | N = 50 | N = 42 | N = 44 | −5.77 | 0.04 | N = 37 | N = 40 | −6.70 | 0.02 |
| Mean ± SD | 33.2 ± 21.3 | 30.6 ± 19.1 | 26.9 ± 19.3 | 31.9 ± 19.6 | [−11.34,−0.21] | 21.2 ± 18.5 | 29.1 ± 20.0 | [−12.50,−0.89] | ||
| Anxiety (HADS-A) | N = 47 | N = 50 | N = 42 | N = 44 | −1.84 | 0.01 | N = 37 | N = 40 | −1.89 | 0.01 |
| Mean ± SD | 7.3 ± 4.6 | 7.8 ± 4.6 | 5.9 ± 4.5 | 8.4 ± 5.3 | [−3.21,−0.47] | 5.1 ± 4.1 | 8.2 ± 5.2 | [−3.32,−0.47] | ||
| Anxiety (HADS-A) | ||||||||||
| No (%) scoring ≥8 | 20 (42.6) | 28 (56.0) | 14 (33.3) | 25 (56.8) | 11 (29.7) | 20 (50.0) | ||||
| Depression (HADS-D) | N = 47 | N = 50 | N = 42 | N = 44 | −1.78 | 0.01 | N = 37 | N = 40 | −1.86 | 0.01 |
| Mean ± SD | 5.5 ± 4.6 | 6.3 ± 3.9 | 4.4 ± 4.3 | 6.8 ± 4.6 | [−3.17,−0.39] | 4.1 ± 3.6 | 7.3 ± 5.5 | [−3.30,−0.43] | ||
| Depression (HADS-D) | ||||||||||
| No (%) scoring ≥8 | 15 (31.9) | 19 (38.0) | 11 (26.2) | 19 (43.2) | 8 (21.6) | 17 (42.5) |
P values for significance, <0.05, <0.025 with correction for multiple comparisons, two sided. N = number of participants with data.