Overview

This trial has been completed.

Conditions health behavior, hypertension
Treatment coaching
Sponsor University of Wisconsin, Madison
Start date September 2015
End date June 2016
Trial size 9 participants
Trial identifier NCT02653573, 2014-1297

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Telephone health coaching over 3 months with supporting education materials.
coaching
Self-management education

Primary Outcomes

Measure
Patient Satisfaction
time frame: 3 months

Secondary Outcomes

Measure
Out-of-clinic blood pressures
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 39 years old.

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

Additional Information

Official title myHEART (My Hypertension Education and Reaching Target) Program: a Feasibility Study of a Young Adult Hypertension Intervention
Principal investigator Heather M Johnson, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.