Table 3.
Changes in Primary and Secondary Outcomes Between Baseline and 6 Months and Baseline and 12 Months
Usual care ITT (N = 727) | SMA ITT* (N = 810) | SMA attendee† (N = 588) | SMA engagement‡ (N = 436) | Between-group 6-month differences (p value) | Between-group 12-month differences (p value) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0- to 6-month change | 0- to 12-month change | 0- to 6-month change | 0- to 12-month change | 0- to 6-month change | 0- to 12-month change | 0- to 6-month change | 0- to 12-month change | SMA ITT v usual care ITT | SMA attendee v usual care ITT | SMA engagement v Usual care ITT | SMA ITT v usual care ITT | SMA attendee v usual care ITT | SMA engagement v usual care ITT | |
Physiologic measures | ||||||||||||||
A1c (%) | − 0.66 (< .001)§ | − 0.79 (< .001) | − 1.01 (< .001) | − 0.95 (< .001) | − 1.08 (< .001) | − 1.00 (< .001) | − 1.19 (< .001) | − 1.08 (< .001) | − 0.35 (0.001) | − 0.42 (< 0.001) | − 0.53 (< 0.001) | − 0.16 (0.12) | − 0.21 (0.07) | − 0.29 (0.06) |
SBP (mmHg) | 0.88 | − 0.80 | − 0.47 | 0.63 | − 0.80 | − 0.42 | − 0.41 | − 0.85 | − 1.35 (0.340) | − 1.88 (0.219) | − 2.05 (0.234) | 1.43 (0.316) | 0.17 (0.911) | − 0.82 (0.634) |
† Med change measures‖ | ||||||||||||||
Insulin starts (yes/no) | 0.72 | 0.69 | 2.17 (< .001) | 2.09 (< .001) | 2.44 (< .001) | 2.86 (< .001) | 2.69 (< .001) | 3.59 (< .001) | 3.00 (0.006) | 3.56 (0.003) | 4.60 (0.005) | 3.02 (0.005) | 3.80 (0.002) | 5.68 (0.001) |
Statin starts (yes/no) | 0.81 | 0.69* | 1.35 | 1.23 | 1.55 | 1.51 | 2.07 (< .001) | 1.99 (< .001) | 1.67 (0.067) | 1.93 (0.034) | 2.83 (0.006) | 1.79 (0.037) | 2.31 (0.007) | 2.63 (0.011) |
Anti-HTN med class changes | 1.02 | 1.02 | 1.01 | 1.01 | 1.01 | 1.02 | 1.01 | 1.01 | 0.99 (0.823) | 0.97 (0.690) | 0.99 (0.839) | 0.99 (0.849) | 0.99 (0.897) | 0.99 (0.854) |
*Includes all those scheduled for an SMA
†Includes all those who attended ≥ 1 SMA
‡Includes all those who attended ≥ ½ of SMAs in series
§p value of intra-group change from baseline
‖Values for Insulin starts and Statin starts are odds ratios, and values for anti-hypertensive medication class changes are incidence rate ratios