Mean Changes in Primary Study Outcomes from Baseline to Follow-up for Participants Followed Up Within 15 Months, by Treatment Arm
| Outcome | Intervention (n = 138) | Control (n = 130) | P valuea |
|---|---|---|---|
| Hemoglobin A1c, mean (SD), % | −0.004 (1.5) | 0.070 (1.3) | .68 |
| Body mass index, mean (SD), kg/m2 | −0.23 (2.4) | −0.49 (2.8) | .44 |
| Systolic blood pressure, mean (SD), mm Hg | −0.41 (21.3) | −1.88 (22.8) | .59 |
| LDL-C, mean (SD), mg/dL | 3.40 (31.5) | −0.18 (31.3) | .35 |
| Quality of life score, mean (SD)b | −0.006 (0.2) | −0.017 (0.2) | .63 |
| Diabetes distress score, mean (SD)c | −0.13 (1.2) | −0.29 (1.1) | .26 |
| Activation score, mean (SD)d | 2.64 (7.4) | 0.69 (7.0) | .04 |
LDL-C = low density lipoprotein cholesterol; SD = standard deviation.
↵a P values are for intervention compared with control group mean values, adjusted for clustering and for education, which was imbalanced at baseline across treatment arms. P-values were derived from χ2 tests for categorical variables and t-tests for continuous variables.
↵b We assessed quality of life using the EuroQol 5D (range 0–1.0).
↵c We assessed diabetes distress using the Diabetes Distress Scale (range 1–6 with scores ≥3 indicative of moderate or greater distress).
↵d We assessed activation using the Patient Activation Measure (range 13–57).