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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Coaching
Home Blood Pressure Monitoring
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring postpartum, chronic hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • UW Hospital and ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health Coaching

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Who Attend 12 month Postpartum Care Visit

Secondary Outcome Measures

Difference in Self-Reported and Electronic Medical Record (EMR) documented BP at 6 months postpartum
Lipid Profile at 12 months postpartum
Hemoglobin A1c at 12 months postpartum
Microalbumin Creatine Ratio at 12 months postpartum
Percentage of participants that achieve hypertension control at 12 months postpartum
Hypertension control will be defined using ambulatory blood pressures as the gold standard (less than 130/80 mmHg); otherwise a clinic blood pressure of less than 140/90 mmHg will be used.
Hypertension Control: Number of Participants who initiate, titrate, or cease BP medications
Hypertension Control: Summary of Antihypertensive Type
Dietary Changes: Change in Sodium intake (milligrams/day) as assessed by the Automated Self-Administered 24-hour Dietary Assessment
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by dietary changes documented on an automated self-administered 24 hour dietary assessment.
Change in physical activity as measured by the Godin Physical Activity Questionnaire
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by change in physical activity as measured by the Godin Physical Activity Questionnaire at 6 and 12 months. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. A score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active.
Change in Home Blood Pressure Monitoring Frequency
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by measuring the frequency of home blood pressure monitoring.
Change in Weight (kg)
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant weight at 6 and 12 months.
Change in Body Mass Index (BMI)
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant BMI at 6 and 12 months.

Full Information

First Posted
January 5, 2023
Last Updated
September 19, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
UnityPoint Health-Meriter Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05685251
Brief Title
Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum
Acronym
STAC-MyHEARTp
Official Title
Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum (STAC-MyHEARTp)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
UnityPoint Health-Meriter Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
postpartum, chronic hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, single-center study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Coaching
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Health Coaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home Blood Pressure Monitoring
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants Who Attend 12 month Postpartum Care Visit
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Difference in Self-Reported and Electronic Medical Record (EMR) documented BP at 6 months postpartum
Time Frame
up to 6 months
Title
Lipid Profile at 12 months postpartum
Time Frame
12 months
Title
Hemoglobin A1c at 12 months postpartum
Time Frame
12 months
Title
Microalbumin Creatine Ratio at 12 months postpartum
Time Frame
12 months
Title
Percentage of participants that achieve hypertension control at 12 months postpartum
Description
Hypertension control will be defined using ambulatory blood pressures as the gold standard (less than 130/80 mmHg); otherwise a clinic blood pressure of less than 140/90 mmHg will be used.
Time Frame
12 months
Title
Hypertension Control: Number of Participants who initiate, titrate, or cease BP medications
Time Frame
up to 12 months
Title
Hypertension Control: Summary of Antihypertensive Type
Time Frame
up to 12 months
Title
Dietary Changes: Change in Sodium intake (milligrams/day) as assessed by the Automated Self-Administered 24-hour Dietary Assessment
Description
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by dietary changes documented on an automated self-administered 24 hour dietary assessment.
Time Frame
6 and 12 months
Title
Change in physical activity as measured by the Godin Physical Activity Questionnaire
Description
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by change in physical activity as measured by the Godin Physical Activity Questionnaire at 6 and 12 months. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. A score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active.
Time Frame
6 and 12 months
Title
Change in Home Blood Pressure Monitoring Frequency
Description
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by measuring the frequency of home blood pressure monitoring.
Time Frame
6 and 12 months
Title
Change in Weight (kg)
Description
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant weight at 6 and 12 months.
Time Frame
6 and 12 months
Title
Change in Body Mass Index (BMI)
Description
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant BMI at 6 and 12 months.
Time Frame
6 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Blohowiak, DO
Phone
(608) 262-5977
Email
sblohowiak@wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Knutson Sinaise
Email
mknutson2@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara K Hoppe, DO
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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