BP Values at End Points
atherosclerotic cardiovascular disease, hypertension, chronic kidney disease, diabetes
ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, HYPERTENSION, DIABETES
There was always a lower BP value in the intervention group compared with the control group during follow-up, with the exception of the 12-month clinic systolic BP. The fact that the control group only demonstrated a significant reduction in clinic BP results and systolic AMBP values may suggest that using only clinic BP measurements may be misleading, as they are a cross-sectional value at a single point compared with the larger range of BP measurements acquired with 24-hour AMBP testing. Given the limited feasibility of 24-hour AMBP, this highlights the importance of incorporating home BP monitoring in hypertension management for a more accurate reflection of BP values across time.Because between study-group differences in BPs were not observed and both study groups improved hypertension control over time, an explanation is warranted. First, the loss to follow-up in this trial was similar in both study groups but 2-fold higher at 6 months than accounted for in our sample size calculation. The study team cannot be sure that that the null results are due to the higher than expected dropout rates; however, a meaningful reduction in BPs in both study groups is appreciated. Second, the MyHEART study design was such that participants received three 24-hour AMBP and 3 in-office study visit BP assessments (at baseline, 6 months, and 12 months). Although the research staff followed protocols, the staff communicated with participants regarding BP results and weight. Perhaps the staff communications served to stimulate motivation or behaviors in the comparison group. These evaluations may have resulted in more attention to both study groups’ hypertension, in addition to prompt potential interactions with the participants’ usual care team. Although enhanced care beyond recommending engagement with routine care with a health care professional was not provided, the unexpected decrease in BPs in both study groups, specifically the control group, may be due to the Hawthorne effect, which refers to the alteration of study participant behavior solely due to being observed rather than the result of an intervention.The rate of clinical hypertension control among study participants at the 6- and 12-month study end points in both study groups and was higher than national estimates, where less than 50% of young adults with hypertension in the US have achieved BP control, even with the former BP guidelines (systolic <140 mm Hg and diastolic <90 mm Hg).Per US guidelines, lifestyle modifications are recommended for the treatment of stage 1 hypertension, in populations with a 10-year atherosclerotic cardiovascular disease risk score of less than 10% and without diabetes or chronic kidney disease.