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

University of Wisconsin (UW)

Status

Completed

Conditions

Hypertension

Treatments

Other: Home Blood Pressure Monitoring

Other: Health Coaching

Study type

Interventional

Funder types

Other

Identifiers

NCT05685251

2023-002 STAC-MyHEARTp

Protocol Version 5/9/2024 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Health condition that will limit both increasing physical activity and changing diet
Illegal drug use (other than marijuana) in the past 30 days
Unable to read or communicate in English
Currently on dialysis or seeing a Nephrologist
Unaware or denies history of high blood pressure or hypertension
Between-arm blood pressure difference >20 mmHg
Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators
Prisoners