Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum — STAC-MyHEARTp  

Hypertension Clinical Trial

Official title: Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum (STAC-MyHEARTp)

Status Recruiting

Clinical Trial Summary

A study of Staying Healthy After Childbirth (STAC) and My Hypertension Education And Reaching Target (MyHEART) for postpartum (p) patients to determine if health coaching can increase 12-month postpartum care attendance, hypertension control and hypertension self-management behavior compared to usual clinical care in patients with chronic hypertension or persistent pregnancy associated hypertension - postpartum. 140 participants will be enrolled and can expect to be on study for 12 months.

Clinical Trial Description

To address the critical need for hypertension (HTN) control in young adults, the investigators developed the MyHEART (My Hypertension Education And Reaching Target) program, a multi-component patient-centered, theoretically-based intervention designed to increase self-management using evidence-based health behavior approaches to lower BP among young adults with uncontrolled HTN.

A nonrandomized, single-center pilot study of MyHEART was conducted, which established feasibility, satisfaction, and informed the design of this trial. A large, multi-site randomized-controlled trial 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 HTN control (secondary) after 6 and 12 months, compared to usual clinical care was completed. Additionally, lifestyle changes and HTN self-management behavior were evaluated.

Incorporating components of the MyHEART intervention with routine clinical care can support HTN behavioral changes in young adults with uncontrolled HTN to support BP lowering in this population. The investigators are in a unique position to partner with the Perinatal Clinic and the current STAC program, to improve health outcomes for women with HTN during pregnancy through health coaching and BP surveillance through 12-months postpartum.

Specific Aims:

• Aim 1: To improve postpartum attendance for 12-month hypertension follow-up care among Staying Healthy After Childbirth patients who have chronic hypertension or persistent hypertension at 6-weeks postpartum.

• Hypothesis: Postpartum follow up care will improve in the intervention compared to usual care.

• Aim 2: To improve blood pressure control at 12-months in postpartum patients with chronic hypertension or a hypertension disorder of pregnancy with persistent HTN at 6-weeks postpartum.

• Hypothesis: Blood pressure control will improve in the intervention (health coaching) arm compared to the usual care arm, via chart review from the 12-month postpartum appointment, and on ambulatory blood pressure monitoring compared to usual care.

• Aim 3: To increase lifestyle modification behaviors and health outcomes relating to nutrition and physical activity and cardiovascular disease (CVD) prevention in postpartum patients with chronic hypertension or a hypertension disorder of pregnancy with persistent HTN at 6-weeks postpartum.

• Hypothesis: Health outcomes including, weight, lipid profile, A1c and microalbumin creatine ratio will improve in the intervention compared to usual care arm, via study surveys and upon chart review from the 12-month postpartum appointment.

Aim 1-3: A total of 140 participants will be enrolled and randomly assigned to the intervention and usual care arms. ;

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT05685251
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Contact: Sharon Blohowiak, DO
• Phone: (608) 262-5977
• Email: sblohowiak@wisc.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Completion date: December 2024