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CompletedNCT03158051

Young Adult Hypertension Self-Management Clinical Trial

The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
316 (actual)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
All
Age
18 Years – 39 Years
Healthy volunteers
Not accepted

Summary

This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.

Detailed description

Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care. Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care. Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).

Conditions

Interventions

TypeNameDescription
BEHAVIORALHome Blood Pressure MonitoringIntervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.
BEHAVIORALTelephone Health CoachingIntervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.

Timeline

Start date
2017-10-02
Primary completion
2022-01-13
Completion
2022-02-08
First posted
2017-05-17
Last updated
2023-05-17
Results posted
2023-05-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03158051. Inclusion in this directory is not an endorsement.