Clinical trial NCT03158051: Young Adult Hypertension Self-Management Clinical Trial
Official title: The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Lifestyle Risk Reduction
Keywords: Hypertension
Young Adult
Self-Management
Health coach
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Wake Forest University Health Sciences
First posted: 2017-05-17
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.

Detailed description: Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care.

Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care.

Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).

Eligibility criteria: Inclusion Criteria:

* Willing and capable of giving written informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Males and females ages 18-39 years old at the start of the study (inclusive)
* A minimum of two hypertension ICD-10 coded visits with a provider (physician \[MD, DO\], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months
* Medically homed at an IRB approved healthcare system

Exclusion Criteria:

* History of medically determined Congestive Heart Failure
* Unable to provide informed consent (i.e., activated healthcare power of attorney)
* Unable or unwilling to travel to local clinic for research visits
* Currently residing in a skilled nursing facility
* Diagnosed with sickle cell anemia or cystic fibrosis
* Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years
* Syncope while exercising or doing strenuous activity within past 12 months
* Currently prescribed warfarin, novel oral anticoagulant, or insulin
* Planned organ transplant or prior transplant in the past 5 years
* Chemotherapy or radiation therapy within 6 the past months
* Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment
* Current participation or planning to participate in another clinical trial in the next 12 months
* Pregnant or planning to become pregnant in the next 12 months
* Planning to leave the geographic area in the next 6 months
* Health condition that will limit both increasing physical activity and changing diet
* Illegal drug use (other than marijuana) in the past 30 days
* Unable to read or communicate in English
* Currently on dialysis or seeing a Nephrologist
* Unaware or denies history of high blood pressure or hypertension
* Between-arm blood pressure difference \>20 mmHg
* White Coat Hypertension (24-hour ambulatory monitoring)
* Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators
* Prisoners

Primary outcomes:
measure: 24-hour Systolic Ambulatory Blood Pressure (mmHg)
timeFrame: baseline, 6 month, and 12 month follow-up
measure: 24-hour Diastolic Ambulatory Blood Pressure (mmHg)
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Clinic Systolic Blood Pressure (mmHg)
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Clinic Diastolic Blood Pressure (mmHg)
timeFrame: baseline, 6 month, and 12 month follow-up
Secondary outcomes:
measure: Number of Participants That Achieve Hypertension Control at 6 Months
timeFrame: up to 6 months
measure: Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Physical Activity as Assessed by the Godin Physical Activity Questionnaire
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Home Blood Pressure Monitoring Frequency
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Standing Weight (kg)
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Perceived Competence as Assessed by the Perceived Competence Scale for Diet
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Perceived Competence as Assessed by the Perceived Competence Scale for Exercise
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
timeFrame: baseline, 6 month, and 12 month follow-up
measure: Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
timeFrame: baseline, 6 month, and 12 month follow-up
Other outcomes:
measure: Health Coach Fidelity to the Study Intervention
timeFrame: through completion of administering the study intervention, an average of 4 years
measure: Adverse Events
timeFrame: Through study completion, an average of 5 years
measure: Serious Adverse Events
timeFrame: Through study completion, an average of 5 years
measure: Withdrawal
timeFrame: Through study completion, an average of 5 years
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine & Public Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kara Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson HM, Sullivan-Vedder L, Kim K, McBride PE, Smith MA, LaMantia JN, Fink JT, Knutson Sinaise MR, Zeller LM, Lauver DR. Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial. Contemp Clin Trials. 2019 Mar;78:88-100. doi: 10.1016/j.cct.2019.01.010. Epub 2019 Jan 21.