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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
316
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.
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.
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
24-hour Systolic Ambulatory Blood Pressure (mmHg)
24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Time frame: 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.
Time frame: baseline, 6 month, and 12 month follow-up
Clinic Systolic Blood Pressure (mmHg)
Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
Time frame: 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.
Time frame: baseline, 6 month, and 12 month follow-up
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.
Time frame: 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
Time frame: 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
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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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline, 6 month, and 12 month follow-up
Standing Weight (kg)
Weight (kg) measured at baseline, 6 months, and 12 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 6 month, and 12 month follow-up