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Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

ABSTRACT: Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Young adults need hypertension self-management programs (i.e., home blood pressure monitoring and lifestyle modifications) tailored to their unique needs to lower blood pressure and reduce the risks and medication burden they may face over a lifetime. To address the unmet need in hypertensive care for young adults, we developed MyHEART (My Hypertension Education And Reaching Target), a multi-component, theoretically-based intervention designed to achieve self-management among young adults with uncontrolled hypertension. MyHEART is a patient-centered program, based upon the Self-Determination Theory, that uses evidence-based health behavior approaches to lower blood pressure. Therefore, the objective of this study is to evaluate MyHEART's impact on changes in systolic and diastolic blood pressure compared to usual care after 6 and 12 months in 310 geographically and racially/ethnically diverse young adults with uncontrolled hypertension. Secondary outcomes include MyHEART's impact on behavioral outcomes at 6 and 12 months, compared to usual clinical care (increased physical activity, decreased sodium intake) and to examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes). MyHEART is one of the first multicenter, randomized controlled hypertension trials tailored to young adults with primary care. The design and methodology will maximize the generalizability of this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03158051.

SUBMITTER: Johnson HM

PROVIDER: S-EPMC6387836 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

Johnson Heather M HM Sullivan-Vedder Lisa L Kim KyungMann K McBride Patrick E PE Smith Maureen A MA LaMantia Jamie N JN Fink Jennifer T JT Knutson Sinaise Megan R MR Zeller Laura M LM Lauver Diane R DR

Contemporary clinical trials 20190121

Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Young adults need hypertension self-management programs (i.e., home blood pressure monitoring and lifestyle modifications) tailored to their unique needs to lower blood p ...[more]

PMID: 30677485

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Project description:BACKGROUND:Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. OBJECTIVE:This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. METHODS:Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ?140 mm Hg and/or diastolic blood pressure [DBP] ?90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. RESULTS:Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. CONCLUSION:We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. TRIAL REGISTRATION:ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).

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Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

Publications

Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

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