Table 2

Mean Changes in Primary Study Outcomes from Baseline to Follow-up for Participants Followed Up Within 15 Months, by Treatment Arm

OutcomeIntervention (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/dL3.40 (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)d2.64 (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).