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Completed

NCT Number: NCT02653573

Young Adult Hypertension Feasibility Study

This study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

To address the unmet need for hypertension care in young adults, MyHEART (My Hypertension Education and Reaching Target), a multi-component hypertension intervention was developed. Eligible patients were identified via the healthcare system's electronic health record.

Inclusion criteria

included:

  • 18-39 years old at the start of the study,
  • previous hypertension ICD-9 coded office visits and
  • uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading.

Exclusion criteria

included a pre-defined list of co-morbidities, in addition to planned or current pregnancy, any health condition that limits physical activity or dietary changes, current participation in another study, and planning to leave the area in the next three months. During the feasibility study, all participants continued to receive usual hypertension care from their primary care provider. The intervention involved health coach calls over a 3-month period using self-management modules. The order of the modules was guided by the participant's choice. All encounters were documented in the electronic health record. Patient acceptability and home blood pressure monitoring survey data was acquired.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-39 years old at the start of the study
  • previous hypertension ICD-9 coded office visits
  • uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading

Exclusion criteria

  • Chronic Kidney Disease (Stage 4 or 5 or Dialysis)
  • Congestive Heart Failure, Any Etiology
  • Activated Healthcare Power of Attorney
  • Skilled nursing facility or correctional facility residence
  • Currently enrolled in case management or chronic disease management support services
  • Sensitive condition diagnosis (e.g. HIV)
  • Prescribed warfarin, novel oral anticoagulant, or insulin
  • Diagnosis of sickle cell anemia or cystic fibrosis
  • Prior stroke, myocardial infarction, coronary artery revascularization
  • Syncope within past 12 months
  • Prior or planned organ transplant
  • Chemotherapy or radiation therapy within 6 months
  • Severely impaired hearing or speech
  • Current participation in another research study
  • Pregnant/planning to become pregnant in the next 12 months
  • Planning to leave the area in the next 3 months
  • Any health condition that will limit physical activity or dietary changes
  • Illegal drug use (other than marijuana) in the past 30 days (Self-report)
  • Unable to read or communicate in English

Treatment and study plan

coaching

Behavioral

Self-management education

Primary outcomes

  1. Patient Satisfaction

    Time frame: 3 months

    Patient satisfaction survey of feasibility study

Secondary outcomes

  1. Out-of-clinic blood pressures

    Time frame: 3 months

    Frequency of home or out-of-clinic blood pressure monitoring

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

myHEART (My Hypertension Education and Reaching Target) Program: a Feasibility Study of a Young Adult Hypertension Intervention

Acronym: myHEART

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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