“[Introduction] [..] MyHEART is a multicomponent, patient-centered, and theoretically based; it includes 4 evidence-based self-management components: (1) telephone-based health coaching with adult education specialists to teach and monitor self-management skills, (2) documentation of coach-patient telephone contacts, (3) individualized hypertension education materials, and (4) home BP monitoring. [..] The primary aim of this study was to evaluate the effect of MyHEART on clinical outcomes, ie, the change in systolic and diastolic BP (primary) and hypertension control (secondary) after 6 and 12 months, compared with usual care. [..]
[Methods] [..] The inclusion criteria included (1) aged 18 to 39 years at enrollment; (2) had a minimum of 2 hypertension International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) coded office visits on different dates 24 months prior to eligibility assessment, with at least 1 code in the past 18 months; and (3) received their medical care in the study institutions. Two clinic BP measurements determined eligibility for a study invitation (ie, systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg), and the last BP measurement must have been within 90 days. BP measurements from inpatient, emergency department, urgent care, and self-report were excluded. [..]
Intervention participants received up to 12 coaching calls (20 min/call), scheduled every 2 weeks for the first 6 months. Coaches were trained on self-determination theory and motivational interviewing. A random sampling of coaches’ calls was assessed with a fidelity checklist, and coaches were given feedback monthly with a behavioral scientist.
Intervention participants received an upper arm BP monitor (Omron, 7 Series) and were instructed to take 2 BP measurements separated by 1 minute, 3 days per week that were shared with the health coach during calls. Detailed instructions on conducting home BP monitoring were provided. [..]
[Results] [..] After completion of preliminary study visits, 316 participants were randomized, with 157 to the intervention group and 159 to the control group. [..]
After randomization, 57 intervention participants (36.3%) and 55 control participants (34.6%) were withdrawn, dropped out, or were lost to follow-up by the 6-month end point and an additional 14 intervention participants (8.9%) and 17 control participants (10%) by the 12-month end point. There were 86 intervention and 89 control participants who completed the 12-month study visits. [..]
At 6 months, there was no significant difference between the control and intervention groups for mean 24-hour AMBP systolic (130.69 [13.99] mm Hg vs 128.14 [11.36] mm Hg; P = .12) or diastolic (85.89 [9.19] mm Hg vs 84.61 [8.24] mm Hg; P = .16) BP at 6 months or clinic systolic (132.50 [15.83] mm Hg vs 130.84 [12.16] mm Hg; P = .44) or diastolic (86.70 [12.44] mm Hg vs 83.83 [9.36] mm Hg; P = .20) BP. Additionally, no differences were identified between groups at 12 months.
In both study groups, there was an appreciable decrease from baseline 6- and 12-month systolic and diastolic clinic BPs (eg, mean [SD] change in systolic blood pressure in intervention group at 6 months, −4.19 [9.77]; P < .001). In a similar analysis to assess for changes in systolic and diastolic BP within study groups, significant reductions were identified from baseline clinic BP and 24-hour AMBP across all time points, except for diastolic BP at 12 months. The control group demonstrated a significant reduction in only clinic BP assessments across all time points. For 24-hour AMBP values in the control group, no significant reductions were found, except for systolic BP at 6 months. [..]
There were significant changes in hypertension self-management behaviors between groups. There was an increase in home BP monitoring between the intervention and control groups at 6 and 12 months (eg, 13 of 152 participants [8.6%] checked blood pressure at home at least once a week at baseline vs 30 of 86 [34.9%] at 12 months; P < .001) (Table 3). There was a significant difference in mean (SD) dietary sodium intake at 6 (3968.20 [1725.17] mg vs 3354.72 [1365.75] mg; P = .003) but not 12 months (4213.67 [1972.37] mg vs 3682.94 [1874.53] mg; P = .14). There was also a difference in physical activity using Godin-Shephard Leisure-Time Physical Activity Questionnaire active status at 6 months (69 of 100 [69.0%] vs 51 of 104 [49.0%]; P = .004) but not at 12 months (49 of 86 [57.0%] vs 49 of 90 [54.4%]; P = .76). No significant changes were identified in mean (SD) weight between study groups at 6 months (103.80 [25.34] kg vs 98.54 [26.19] kg; P = .43) or 12 months (103.45 [25.49] kg vs 97.91 [26.07] kg; P = .39). There was no difference in combined fruit and vegetable servings, whole grain intake, or saturated fat intake at 6 or 12 months. [..]
[Discussion] [..] The MyHEART study represents successful recruitment, enrollment, and engagement of racially and geographically diverse young adults. The trial did not demonstrate a significant change between study groups in systolic or diastolic BP or the secondary outcome of hypertension control at 6 or 12 months. However, both study groups demonstrated an overall decrease in systolic and diastolic BPs at 6 and 12 months. The interval change in clinic and 24-hour AMBP systolic and diastolic from baseline to 6 and 12 months was evaluated, and we found the intervention group had a significant reduction in all 6- and 12-month BP values except the 12-month 24-hour AMBP results in comparison with the baseline values. The control group demonstrated a significant reduction in all of the clinic BP values and only the systolic 24-hour AMBP result at 6 months. Compared with the control group, intervention participants demonstrated a significant increase in physical activity, reduction in dietary sodium intake, and increase in home BP monitoring at 6 months. The increase in physical activity and reduction in dietary sodium intake was not maintained at 12 months. Participants still had an increase in performing home BP monitoring at 12 months, albeit at a lower rate.”
Full article, K Hoppe, M Smith, J Birstler et al. JAMA Network Open, 2023.2.3