Young Adult Hypertension Self-Management Clinical Trial

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).

• Home Blood Pressure Monitoring (Behavioral): 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.
• Telephone Health Coaching (Behavioral): 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.

Primary outcomes

• 24-hour Systolic Ambulatory Blood Pressure (mmHg) [baseline, 6 month, and 12 month follow-up]: 24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
• 24-hour Diastolic Ambulatory Blood Pressure (mmHg) [baseline, 6 month, and 12 month follow-up]: 24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
• Clinic Systolic Blood Pressure (mmHg) [baseline, 6 month, and 12 month follow-up]: Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
• Clinic Diastolic Blood Pressure (mmHg) [baseline, 6 month, and 12 month follow-up]: Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.

Secondary outcomes

• Number of Participants That Achieve Hypertension Control at 6 Months [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.
• Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment [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
• Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment [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.
• Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment [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
• Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment [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
• Physical Activity as Assessed by the Godin Physical Activity Questionnaire [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.
• Home Blood Pressure Monitoring Frequency [baseline, 6 month, and 12 month follow-up]: Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.
• Standing Weight (kg) [baseline, 6 month, and 12 month follow-up]: Weight (kg) measured at baseline, 6 months, and 12 months.
• Perceived Competence as Assessed by the Perceived Competence Scale for Diet [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.
• Perceived Competence as Assessed by the Perceived Competence Scale for Exercise [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.
• Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet [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.
• Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise [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.
• Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet [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.
• Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise [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.
• Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet [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.
• Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise [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.
• Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet [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.
• Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise [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.

Other outcomes

• Health Coach Fidelity to the Study Intervention [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
• Adverse Events [Through study completion, an average of 5 years]: Number and type of adverse events
• Serious Adverse Events [Through study completion, an average of 5 years]: Number and type of serious adverse events
• Withdrawal [Through study completion, an average of 5 years]: Subject Withdrawal Rate

Sex: All, ages: 18 Years to 39 Years

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

Participant flow

Outcome results

• 24-hour Systolic Ambulatory Blood Pressure (mmHg) (Primary), Median, mmHg: Intervention 132.59 +/- 11.36; Usual Clinical Care 133.01 +/- 12.67
• 24-hour Diastolic Ambulatory Blood Pressure (mmHg) (Primary), Mean, mmHg: Intervention 86.45 +/- 7.76; Usual Clinical Care 87.04 +/- 8.16
• Clinic Systolic Blood Pressure (mmHg) (Primary), Median, mmHg: Intervention 138.30 +/- 14.27; Usual Clinical Care 137.97 +/- 14.33
• Clinic Diastolic Blood Pressure (mmHg) (Primary), Mean, mmHg: Intervention 90.81 +/- 11.42; Usual Clinical Care 91.77 +/- 11.26
• Number of Participants That Achieve Hypertension Control at 6 Months (Secondary), Count of participants, Participants: Intervention 20; Usual Clinical Care 21
• Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment (Secondary), Mean, milligrams per day: Intervention 3512.82 +/- 1765.59; Usual Clinical Care 3672.81 +/- 1812.82
• Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment (Secondary), Mean, cups per day: Intervention 2.34 +/- 2.02; Usual Clinical Care 2.50 +/- 1.98
• Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment (Secondary), Mean, ounces per day: Intervention 0.61 +/- 1.05; Usual Clinical Care 0.85 +/- 1.41
• Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment (Secondary), Mean, percent kilocalories: Intervention 11.91 +/- 4.19; Usual Clinical Care 12.54 +/- 4.32
• Physical Activity as Assessed by the Godin Physical Activity Questionnaire (Secondary), Mean, score on a scale: Intervention 38.24 +/- 31.51; Usual Clinical Care 37.24 +/- 26.99
• Home Blood Pressure Monitoring Frequency (Secondary), Count of participants, Participants: Intervention 109; Usual Clinical Care 118
• Standing Weight (kg) (Secondary), Mean, kilograms: Intervention 102.86 +/- 28.64; Usual Clinical Care 102.93 +/- 27.30
• Perceived Competence as Assessed by the Perceived Competence Scale for Diet (Secondary), Mean, score on a scale: Intervention 4.54 +/- 1.34; Usual Clinical Care 4.56 +/- 1.30
• Perceived Competence as Assessed by the Perceived Competence Scale for Exercise (Secondary), Mean, score on a scale: Intervention 4.83 +/- 1.45; Usual Clinical Care 5.03 +/- 1.46
• Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet (Secondary), Mean, score on a scale: Intervention 4.63 +/- 1.60; Usual Clinical Care 4.93 +/- 1.58
• Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise (Secondary), Mean, score on a scale: Intervention 4.72 +/- 1.65; Usual Clinical Care 5.00 +/- 1.53
• Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet (Secondary), Mean, score on a scale: Intervention 5.80 +/- 1.02; Usual Clinical Care 5.80 +/- 1.06
• Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise (Secondary), Mean, score on a scale: Intervention 5.81 +/- 1.04; Usual Clinical Care 5.81 +/- 1.07
• Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet (Secondary), Mean, score on a scale: Intervention 3.19 +/- 1.25; Usual Clinical Care 3.04 +/- 1.23
• Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise (Secondary), Mean, score on a scale: Intervention 3.20 +/- 1.23; Usual Clinical Care 3.06 +/- 1.25
• 6 more outcome measures not shown.

Adverse events

Time frame: up to 13 months

Serious adverse events by term

Other adverse events by term

• 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. PMID 30677485
• Results publication: Hoppe KK, Smith M, Birstler J, Kim K, Sullivan-Vedder L, LaMantia JN, Knutson Sinaise MR, Swenson M, Fink J, Haggart R, McBride P, Lauver DR, Johnson HM. Effect of a Telephone Health Coaching Intervention on Hypertension Control in Young Adults: The MyHEART Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255618. doi: 10.1001/jamanetworkopen.2022.55618. PMID 36735261

• Study Protocol and Statistical Analysis Plan (PDF, 2022-05-04)

• Kara Hoppe, DO, Principal investigator, University of Wisconsin, Madison

NIH grants: R01HL132148