Young Adult Hypertension Self-Management Clinical Trial
Status: | Recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 39 |
Updated: | 8/16/2018 |
Start Date: | October 2, 2017 |
End Date: | April 30, 2022 |
Contact: | Jamie Lamantia |
Email: | jnlamantia@medicine.wisc.edu |
Phone: | 608/262-8311 |
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.
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).
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).
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
We found this trial at
2
sites
Milwaukee, Wisconsin 53215
Principal Investigator: Lisa Sullivan Vedder, MD
Phone: 414-219-4873
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750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Principal Investigator: Heather M Johnson
Phone: 608-262-2075
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