Young Adult Hypertension Feasibility Study

Not Applicable

Completed

• Conditions: Hypertension; Health Behavior
• Interventions: Behavioral: Coaching

• Registration Number: NCT02653573
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-12
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Coaching	Telephone health coaching over 3 months with supporting education materials.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	3 months	Patient satisfaction survey of feasibility study

Secondary Outcome Measures

Name	Time	Method
Out-of-clinic blood pressures	3 months	Frequency of home or out-of-clinic blood pressure monitoring