Young Adult Hypertension Feasibility Study

NCT ID: NCT02653573

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Health Behavior; Hypertension

Keywords

young adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Telephone health coaching over 3 months with supporting education materials.

Group Type: EXPERIMENTAL

Coaching

Intervention Type: BEHAVIORAL

Self-management education

Interventions

Coaching

Self-management education

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather M Johnson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of WI School of Medicine and Public Health

Other Identifiers

2014-1297

Identifier Type: -

Identifier Source: org_study_id