Table 1.
Primary and secondary outcomes
| Outcome | Treatment arm |
Intervention (n = 11) | P value |
|---|---|---|---|
| Control (n = 15) | |||
| Adherence, n (%) | |||
| Median PDC, composite (primary) | 99 (95, 100) | 94 (88, 96) | .034 |
| PDC ≥ 80%, composite | 14 (93%) | 9 (82%) | .56 |
| Median PDC, statin | 99 (96, 100) | 96 (91, 99) | .14 |
| Median PDC, P2Y12 inhibitor | 99 (97, 100) | 92 (74, 100) | .73 |
| PDC ≥ 80%, statin | 15 (100%) | 10 (91%) | .42 |
| PDC ≥ 80%, P2Y12 inhibitor | 5 (33%) | 3 (27%) | 1.00 |
| Time to first fill [days] | 3 (n=2) | 0 (n=1) | NA |
| Persistence, n (%) | |||
| Persistent to prescribed therapy | 15 (100%) | 11 (100%) | NA |
| Cardiovascular risk factors | |||
| Median serum LDL-C [mg/dL] | 46 (23, 78) | 54 (34, 97) | .44 |
| Participants within target BP, n (%) | 11 (79%) | 7 (70%) | .67 |
| Diabetics with HbA1c ≤ 7%, n (%) | 1/2 (50%) | 1/2 (50%) | 1.00 |
| Absolute change in body weight [kg] | 0.2 (-5.5, 5.5) | 0.3 (-6.7, 2.8) | .93 |
| Relative % change in body weight [kg] | 0.3 (-2.0, 1.0) | 0.3 (-2.0, 1.2) | .84 |
| Quality of life (self-reported) | n=12 | n=8 | |
| EQ-5D-3L, reporting no problems, n (%) | |||
| Mobility | 11 (92%) | 5 (63%) | .26 |
| Self-care | 11/11 (100%) | 8 (100%) | NA |
| Usual activities | 12 (100%) | 7 (88%) | .40 |
| Pain/discomfort | 9 (75%) | 6 (75%) | 1.00 |
| Anxiety/depression | 10 (83%) | 7 (88%) | 1.00 |
| Change in EQ VAS | 4 (-28, 26) | 0 (-16, 20) | .96 |
| Patient activation (self-reported) | n=12 | n=8 | |
| Change in PAM® level, n (%) | .82 | ||
| -2 | 1 (8%) | 0 | |
| -1 | 0 | 1 (13%) | |
| 0 | 8 (67%) | 5 (63%) | |
| 1 | 1 (8%) | 1 (13%) | |
| Weekly physical activity (self-reported) | n=10 | n=8 | |
| Miles walked | 7 (3.5, 19.3) | 11 (5.8, 18.4) | .86 |
| Stairs climbed | 315 (175, 735) | 700 (508, 875) | .21 |
| Self-perception, exercise participation, n (%) | 1.00 | ||
| Sufficient exercise to keep healthy | 4 (40%) | 4 (50%) | |
| Insufficient exercise to keep healthy | 6 (60%) | 4 (50%) | |
| Activity hours on a typical day | |||
| Vigorous | 1 (0, 6) | 1 (0, 2.5) | .76 |
| Moderate | 2 (0, 8) | 2 (0.5, 6) | .96 |
| Light | 4.5 (2, 6) | 5 (3.5, 9) | .29 |
| Sitting | 5 (1, 12) | 7 (4, 10) | .15 |
| Sleeping or reclining | 8 (4, 9) | 8 (7, 9) | .46 |
| Exploratory outcomes | |||
| 30-day hospitalization for any reason | 1 (7%) | 1 (9%) | 1.00 |
| Major adverse cardiac events (MACE) | 1 (7%) | 0 | NA |
Continuous and categorical variables are reported as median (IQR) and count (percent) unless otherwise noted. MACE is a composite of death, myocardial infarction, acute coronary syndrome, out-of-hospital cardiac arrest, stent thrombosis, or repeat revascularization after 90 days.
EQ-5D-3L = European quality of life 5 dimensions 3 level version; NA = not applicable; PDC = proportion of days covered; PAM = patient activation measure; VAS = visual analogue scale.
P values for continuous and categorical variables are based on the Mann-Whitney U and Fisher exact test, respectively.