Health Coaching + Home Monitoring for Postpartum High Blood Pressure

(STAC-MyHEARTp Trial)

Overseen By Megan Knutson Sinaise

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: Antihypertensives

Must not be taking: Warfarin, Insulin

Disqualifiers: Congestive heart failure, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kara K Hoppe, DO

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for postpartum patients with high blood pressure, either persistent from pregnancy or chronic. Participants must be willing to follow the study procedures for 12 months, have completed a 6-week program, and not planning any major medical treatments or other clinical trials that could interfere. They should not be pregnant nor planning pregnancy within the year.

Inclusion Criteria

I am genetically female.

I completed a 6-week program and still have high blood pressure or take medication for it.

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

I have been diagnosed with sickle cell anemia or cystic fibrosis.

Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment

I cannot or do not want to travel to the clinic for study visits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health coaching and home blood pressure monitoring as part of the MyHEART program

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on hypertension control and lifestyle modifications

4 weeks

Treatment Details

Interventions

• Health Coaching
• Home Blood Pressure Monitoring

Trial Overview The STAC and MyHEART programs are being tested to see if health coaching alongside home blood pressure monitoring can improve care attendance, control of hypertension, and self-management behaviors in postpartum women with high blood pressure compared to usual care.

Participant Groups

Group I: Health Coaching Experimental Treatment 2 Interventions

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+

UnityPoint Health-Meriter Foundation

Collaborator

Trials

2

Recruited

200+