Young Adult Hypertension Self-Management Clinical Trial (MyHEART)

May 15, 2023 updated by: University of Wisconsin, Madison

The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin School of Medicine & Public Health
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials
Behavioral: Home Blood Pressure Monitoring
Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.
Behavioral: Telephone Health Coaching
Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.
No Intervention: Usual clinical care
Usual care arm participants will receive routine hypertension clinical care per their primary care provider.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour Systolic Ambulatory Blood Pressure (mmHg)
Time Frame: baseline, 6 month, and 12 month follow-up
24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
baseline, 6 month, and 12 month follow-up
24-hour Diastolic Ambulatory Blood Pressure (mmHg)
Time Frame: baseline, 6 month, and 12 month follow-up
24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
baseline, 6 month, and 12 month follow-up
Clinic Systolic Blood Pressure (mmHg)
Time Frame: baseline, 6 month, and 12 month follow-up
Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
baseline, 6 month, and 12 month follow-up
Clinic Diastolic Blood Pressure (mmHg)
Time Frame: baseline, 6 month, and 12 month follow-up
Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.
baseline, 6 month, and 12 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants That Achieve Hypertension Control at 6 Months
Time Frame: up to 6 months
Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (<130/80 mmHg); otherwise a clinic blood pressure of <140/90 mmHg will be used.
up to 6 months
Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time Frame: baseline, 6 month, and 12 month follow-up
Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment
baseline, 6 month, and 12 month follow-up
Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time Frame: baseline, 6 month, and 12 month follow-up
Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent.
baseline, 6 month, and 12 month follow-up
Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time Frame: baseline, 6 month, and 12 month follow-up
Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment
baseline, 6 month, and 12 month follow-up
Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time Frame: baseline, 6 month, and 12 month follow-up
Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories
baseline, 6 month, and 12 month follow-up
Physical Activity as Assessed by the Godin Physical Activity Questionnaire
Time Frame: baseline, 6 month, and 12 month follow-up

Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time):

  • 9 x strenous units reported + 5 x moderate units reported + 3 x light units reported = score

A minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist.
baseline, 6 month, and 12 month follow-up
Home Blood Pressure Monitoring Frequency
Time Frame: baseline, 6 month, and 12 month follow-up
Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.
baseline, 6 month, and 12 month follow-up
Standing Weight (kg)
Time Frame: baseline, 6 month, and 12 month follow-up
Weight (kg) measured at baseline, 6 months, and 12 months.
baseline, 6 month, and 12 month follow-up
Perceived Competence as Assessed by the Perceived Competence Scale for Diet
Time Frame: baseline, 6 month, and 12 month follow-up
Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.
baseline, 6 month, and 12 month follow-up
Perceived Competence as Assessed by the Perceived Competence Scale for Exercise
Time Frame: baseline, 6 month, and 12 month follow-up
Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.
baseline, 6 month, and 12 month follow-up
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet
Time Frame: baseline, 6 month, and 12 month follow-up
Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.
baseline, 6 month, and 12 month follow-up
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise
Time Frame: baseline, 6 month, and 12 month follow-up
Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.
baseline, 6 month, and 12 month follow-up
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Time Frame: baseline, 6 month, and 12 month follow-up
Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.
baseline, 6 month, and 12 month follow-up
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Time Frame: baseline, 6 month, and 12 month follow-up
Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.
baseline, 6 month, and 12 month follow-up
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Time Frame: baseline, 6 month, and 12 month follow-up
Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.
baseline, 6 month, and 12 month follow-up
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Time Frame: baseline, 6 month, and 12 month follow-up
Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.
baseline, 6 month, and 12 month follow-up
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Time Frame: baseline, 6 month, and 12 month follow-up
Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.
baseline, 6 month, and 12 month follow-up
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Time Frame: baseline, 6 month, and 12 month follow-up
Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.
baseline, 6 month, and 12 month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Coach Fidelity to the Study Intervention
Time Frame: through completion of administering the study intervention, an average of 4 years
Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index
through completion of administering the study intervention, an average of 4 years
Adverse Events
Time Frame: Through study completion, an average of 5 years
Number and type of adverse events
Through study completion, an average of 5 years
Serious Adverse Events
Time Frame: Through study completion, an average of 5 years
Number and type of serious adverse events
Through study completion, an average of 5 years
Withdrawal
Time Frame: Through study completion, an average of 5 years
Subject Withdrawal Rate
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Aurora Health Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kara Hoppe, DO, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-0372
  • A534225 (Other Identifier: UW Madison)
  • SMPH\MEDICINE\CARDIOLOGY (Other Identifier: UW Madison)
  • R01HL132148 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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