Young Adult Hypertension Self-Management Clinical Trial

Not Applicable

Completed

Conditions: Lifestyle Risk Reduction
Hypertension
Blood Pressure

Interventions: Behavioral: Home Blood Pressure Monitoring
Behavioral: Telephone Health Coaching

Registration Number: NCT03158051

Lead Sponsor: University of Wisconsin, Madison

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 316

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Home Blood Pressure Monitoring	Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials
Intervention	Telephone Health Coaching	Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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.
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.
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.
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
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.
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.
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 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.
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
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.
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.
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.
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.

Trial Locations

Locations (2): University of Wisconsin School of Medicine & Public Health
🇺🇸
Madison, Wisconsin, United States
Aurora Health Care
🇺🇸
Milwaukee, Wisconsin, United States