Mobile Health Program for Post-Preeclampsia Hypertension
Purpose
Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.
Conditions
- Hypertension (HTN)
- Preeclampsia
- Hypertensive Disorders of Pregnancy (HDP)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP. - Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).
Exclusion Criteria
- Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease). - Males will also be excluded from this study as it focuses on pregnancy related conditions. - Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be assigned to the intervention or usual care by the study team, and they will be informed at the time of consent what group they will participate in
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Coaching Application + HBPM |
A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring and provide guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control. The application is connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 3-month intervention duration and a Bluetooth blood pressure cuff. |
|
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Active Comparator Enhanced usual care with WebMD |
Enhanced usual care participants will receive a smartphone for the 3-month intervention duration and the wireless Bluetooth blood pressure cuff. Through this, enhanced usual care participants will have access to WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants will also receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. |
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Recruiting Locations
Pittsburgh, Pennsylvania 15213
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh