Clinical trial NCT02653573: Young Adult Hypertension Feasibility Study
Official title: myHEART (My Hypertension Education and Reaching Target) Program: a Feasibility Study of a Young Adult Hypertension Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Hypertension
Keywords: young adult
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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:

1. 18-39 years old at the start of the study,
2. previous hypertension ICD-9 coded office visits and
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Out-of-clinic blood pressures
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of WI School of Medicine and Public Health
name: Heather M Johnson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: