Young Adult Hypertension Self-Management Clinical Trial

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hypertension, Blood Pressure, Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: Home Blood Pressure Monitoring
* Behavioral: Telephone Health Coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials | Behavioral: Home Blood Pressure Monitoring<br>* 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.<br>Behavioral: Telephone Health Coaching<br>* 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.<br>|
| No Intervention: Usual clinical care<br>Usual care arm participants will receive routine hypertension clinical care per their primary care provider. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 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) | 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) | Systolic Blood Pressure measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up | 
| Clinic Diastolic Blood Pressure (mmHg) | Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Achieve Hypertension Control at 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Young Adult, Self-Management, Health coach