Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum

NCT05685251 | Completed

• 2 other identifiers: 2025-0768Protocol Version 5/9/2024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

postpartum; chronic hypertension

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Attend 12 month Postpartum Care Visit

  up to 12 months

Secondary Outcomes (12)

• Difference in Self-Reported and Electronic Medical Record (EMR) documented BP at 6 months postpartum

  up to 6 months

• Lipid Profile at 12 months postpartum

  12 months

• Hemoglobin A1c at 12 months postpartum

  12 months

• Microalbumin Creatine Ratio at 12 months postpartum

  12 months

• Percentage of participants that achieve hypertension control at 12 months postpartum

  12 months

Study Arms (2)

Health Coaching

EXPERIMENTAL

Other: Health Coaching; Other: Home Blood Pressure Monitoring

Standard of Care

NO INTERVENTION

Interventions

Health Coaching OTHER

Participants will receive a health coach telehealth/video visit or phone call every 2 weeks for 4 months, for a total of 8 calls. After these initial 8 calls, at approximately 6 months postpartum, the health coach will schedule maintenance calls 1 per month until approximately 12 months postpartum, for a total of 6 additional calls.

Health Coaching

Home Blood Pressure Monitoring OTHER

Participants will be provided an A\&D UA-651 (BT) home blood pressure monitor with an appropriate cuff size, they will be asked to take their blood pressure at least three days a week, 2 measurements each time

Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of giving written informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Genetically female
• Patients who complete the 6-week program, had a hypertension disorder of pregnancy who have persistent hypertension (systolic blood pressure greater than 130 mmHg or diastolic blood pressure greater than 80 mmHg) and/or are still on antihypertensive medication and those with chronic hypertension (CHTN) will be eligible to participate.
• Medically homed at UW Health or UPH

You may not qualify if:

• Inability to participate in health coaching (i.e., no reliable phone contact or Wi-Fi
• History of medically determined Congestive Heart Failure
• Unable to provide informed consent (i.e., activated healthcare power of attorney)
• Unable or unwilling to travel to local clinic for research visits
• Currently residing in a skilled nursing facility
• Diagnosed with sickle cell anemia or cystic fibrosis
• Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years
• Syncope while exercising or doing strenuous activity within past 12 months
• Currently prescribed warfarin, novel oral anticoagulant, or insulin
• Planned organ transplant or prior transplant in the past 5 years
• Chemotherapy or radiation therapy within 6 the past months
• Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment
• Current participation or planning to participate in another clinical trial in the next 12 months that involves hypertension management/control
• Pregnant or planning to become pregnant in the next 12 months
• Planning to leave the geographic area in the next 12 months

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Meriter Foundation: collaborator

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kara K Hoppe, DO

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-center study

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 17, 2023
• Study Start: February 22, 2023
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)