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Young Adult Hypertension Self-Management Clinical Trial (MyHEART)

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Hypertension
Lifestyle Risk Reduction
Blood Pressure

Treatments

Behavioral: Home Blood Pressure Monitoring
Behavioral: Telephone Health Coaching

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03158051
SMPH\MEDICINE\CARDIOLOGY (Other Identifier)
2017-0372
R01HL132148 (U.S. NIH Grant/Contract)
A534225 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

316 patients

Sex

All

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

316 participants in 2 patient groups

Intervention
Experimental group
Description:
Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials
Treatment:
Behavioral: Home Blood Pressure Monitoring
Behavioral: Telephone Health Coaching
Usual clinical care
No Intervention group
Description:
Usual care arm participants will receive routine hypertension clinical care per their primary care provider.

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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