Young Adult Hypertension Feasibility Study

Hypertension Clinical Trial

— myHEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653573
• Other study ID #: 2014-1297
• Status: Completed
• Phase: N/A
• First received: December 28, 2015
• Last updated: October 26, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Behavior
• Hypertension

Intervention

Behavioral:
• Coaching
Self-management education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Patient satisfaction survey of feasibility study	3 months	No
Secondary	Out-of-clinic blood pressures	Frequency of home or out-of-clinic blood pressure monitoring	3 months	No