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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether health coaching can help new mothers manage high blood pressure after childbirth more effectively. Researchers aim to determine if this approach improves attendance at postpartum care visits, controls blood pressure, and encourages self-care compared to regular medical care. Participants will either receive health coaching or continue with their usual care. Women with pregnancy-related high blood pressure that remains elevated or who are on medication for it may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance postpartum care for future mothers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently prescribed warfarin, novel oral anticoagulants, or insulin, you cannot participate in the trial.

What prior data suggests that health coaching and home blood pressure monitoring are safe for postpartum patients?

Research shows that participants usually receive health coaching well. Studies have found that health coaching can significantly improve healthcare management and help lower blood pressure in the first year after childbirth. This suggests that participants might find the coaching both safe and helpful.

In a past study, researchers examined health coaching provided remotely to new parents with high blood pressure. They found the program easy to follow and well-accepted, indicating participants managed it without major issues.

Overall, health coaching appears safe, with no serious side effects reported. Participants in these studies generally responded positively, which is encouraging for anyone considering a clinical trial that includes health coaching. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for postpartum high blood pressure, which often rely on medications, this new approach combines health coaching with home monitoring. Researchers are excited about this trial because health coaching offers a personalized, supportive way to help new mothers manage their blood pressure effectively. It empowers them with knowledge and lifestyle strategies, potentially reducing the need for medication. Additionally, home monitoring allows for real-time tracking, making it easier to spot and address blood pressure changes quickly. This method could lead to better health outcomes by emphasizing preventive care and patient engagement.

What evidence suggests that health coaching and home blood pressure monitoring could be effective for postpartum high blood pressure?

Research has shown that health coaching, which participants in this trial may receive, can help manage high blood pressure after childbirth. One study found that health coaching lowered both systolic and diastolic blood pressure in new mothers and increased their likelihood of attending follow-up doctor visits. Another study found that a digital health coaching program called Smarter Pregnancy reduced blood pressure in mothers. Overall, these findings suggest that health coaching can help control blood pressure and encourage greater involvement with healthcare after giving birth. ^{1 3 4 6 7}

Who Is on the Research Team?

Kara K Hoppe, DO

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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

Currently residing in a skilled nursing facility

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39780489/

Postpartum Remote Health Coaching Intervention for ... We aimed in this study to assess (1) the feasibility and acceptability of a remotely delivered PA intervention for individuals with HDP 3-6 months postpartum.

2. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X25000204

Postpartum Remote Health Coaching Intervention for ... We aimed in this study to assess (1) the feasibility and acceptability of a remotely delivered PA intervention for individuals with HDP 3‐6 months postpartum.

3. researchgate.net researchgate.net/publication/396640023_Abstract_FR582_STAC-MyHEARTp_A_randomized_controlled_trial_of_health_coaching_and_self-measured_blood_pressure_to_increase_health_care_engagement_and_blood_pressure_control_in_the_first_year_postpartu

A randomized controlled trial of health coaching and self ... Health coaching significantly increased healthcare engagement, lowered systolic and diastolic blood pressure, and increased blood pressure ...

4. iro.uiowa.edu iro.uiowa.edu/view/pdfCoverPage?instCode=01IOWA_INST&filePid=13933674920002771&download=true

A remote postpartum physical activity intervention for ... Maternal and Neonatal Health Outcomes: Health outcomes of both the participant and their child were assessed via a self-report questionnaire.

5. ajpmonline.org ajpmonline.org/article/s0749-3797(24)00403-3/fulltext

Smarter Pregnancy Coaching and Maternal Blood Pressure This study aims to determine the effectiveness of using the digital health lifestyle coaching program Smarter Pregnancy on maternal BP reduction ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05685251

NCT05685251 | Staying Healthy After Childbirth: My ... A study of Staying Healthy After Childbirth (STAC) and My Hypertension Education And Reaching Target (MyHEART) for postpartum (p) patients

7. formative.jmir.org formative.jmir.org/2025/1/e65611

Postpartum Remote Health Coaching Intervention for ... We aimed in this study to assess (1) the feasibility and acceptability of a remotely delivered PA intervention for individuals with HDP 3‐6 months postpartum.