Table 2.
Primary and secondary endpoints of Stepping Up model of care trial: biochemical, clinical, and psychological outcomes. Values are mean (SD) or median (interquartile range) unless stated otherwise
| Endpoints | Intervention arm | Control arm | Adjusted data for baseline measure and clustering | |
|---|---|---|---|---|
| Treatment effect (95% CI) | P value | |||
| HbA1c (%): | ||||
| Baseline | 8.7 (8.1-9.7) | 8.5 (8-9.6) | ||
| Follow-up | 7.4 (6.9-8.2) | 8.0 (7.1-9.0) | ||
| Change | −1.3 (1.4) | −0.6 (1.5) | −0.6 (−0.9 to −0.3) | <0.001 |
| No (%) of participants using insulin: | ||||
| Follow-up | 105 (69.5) | 25 (21.7) | 8.3* (4.5 to 15.4) | <0.001 |
| No (%) of participants with HbA1c ≤53 mmol/mol (7%): | ||||
| Follow-up | 54 (35.8) | 24 (20.9) | 2.2* (1.2 to 4.3) | 0.02 |
| Depressive symptoms (PHQ-9)†: | ||||
| Baseline | 3 (1-7) | 2 (1-6.5) | ||
| Follow-up | 2 (0-5) | 2 (0-5) | ||
| Change | −1.1 (3.5) | −0.1 (2.9) | −0.8 (−1.6 to −0.01) | 0.047 |
| No (%) of participants with moderate-severe depressive symptoms (PHQ-9 total: ≥10)‡: | ||||
| Baseline | 22 (15.1) | 15 (13.5) | ||
| Follow-up | 19 (12.8) | 15 (13.3) | 0.82* (0.3 to 2.2) | 0.69 |
| Diabetes specific distress (PAID)§: | ||||
| Baseline | 15 (6.3-31.3) | 12.5 (5-23.8) | 0.14 | |
| Follow-up | 8.8 (3.8-22.5) | 10 (2.5-23.8) | ||
| Change | −5.6 (15.5) | −2.4 (15.4) | −1.9 (−5.1 to 1.3) | 0.24 |
| No (%) of participants with severe diabetes specific distress (PAID total: ≥40)‡: | ||||
| Baseline | 25 (16.8) | 14 (12.4) | ||
| Follow-up | 18 (12.1) | 12 (10.4) | 1.0* (0.4 to 2.3) | 0.93 |
| Health status (AQoL-8D) physical component score¶: | ||||
| Baseline | 0.63 (0.20) | 0.61 (0.21) | ||
| Follow-up | 0.66 (0.21) | 0.64 (0.21) | 0.52 | |
| Change | 0.03 (0.15) | 0.02 (0.13) | 0.01 (−0.03 to 0.04) | 0.64 |
| Health status (AQoL-8D) mental component score¶: | ||||
| Baseline | 0.45 (0.20) | 0.45 (0.22) | ||
| Follow-up | 0.48 (0.21) | 0.45 (0.22) | ||
| Change | 0.04 (0.16) | −0.002 (0.13) | 0.04 (0.002 to 0.08) | 0.04 |
| Weight (kg): | ||||
| Baseline | 90.8 (19.6) | 94.6 (18.9) | ||
| Follow-up | 92.5 (20.1) | 93.5 (18.9) | ||
| Change | 1.7 (5.2) | −1.1 (5.1) | 2.8 (1.5 to 4.0) | <0.001 |
*Odds ratio.
†Patient health questionnaire 9. Range of possible scores: 0-27. A total score of ≥10 indicates at least moderate depressive symptoms. Data available for 261 patients at baseline (149 intervention, 112 control) and 263 at 12 months (149 intervention, 114 control; intention to treat (ITT) population).
‡Data available for 257 patients at baseline (146 intervention, 111 control) and 261 at 12 months (148 intervention, 113 control; ITT).
§Problem areas in diabetes. Range of possible scores: 0-100. A score of ≥40 indicates severe diabetes related distress. Data available for 262 patients at baseline (149 intervention, 113 control) and 264 at 12 months (149 intervention, 115 control; ITT).
¶Assessment of quality of life. Maximum possible score is 1. Higher scores indicate better generic health status. Data available for 262 patients at baseline (149 intervention, 113 control) and 263 at 12 months (149 intervention, 114 control; ITT).