Mobile Health Program for Post-Preeclampsia Hypertension

Official title

Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy

Overview

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.

Interventions

• Behavioral Coaching application
  A digital application for providing education and support for home-based blood pressure monitoring.
• Behavioral Home-based blood pressure monitoring
  Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
• Other WebMD
  Smartphone-based application for health education and/or monitoring.

Primary outcome measures

• Change in systolic blood pressure from baseline to 3 months [Time frame: Baseline, 3 Months]

Secondary outcome measures (9)

• Change in diastolic BP and mean arterial pressure from baseline to 3 months [Time frame: Baseline, 3 months]
• Adherence to antihypertensive medications at 3 months and 6 months [Time frame: Baseline, 6 months]
• Proportion with BP controlled <130/80 mmHg at 3 months and 6 months [Time frame: Baseline, 3 months, 6 months]
• Adherence to home blood pressure monitoring [Time frame: Baseline, 3 months]
• Feasibility of study measured using enrollment, survey completion, and retention of participants [Time frame: Baseline, 3 Month, 6 Month]
• Durable change in systolic blood pressure measures at 6 months [Time frame: Baseline, 6 months]
• Durable change in diastolic BP measures at 6 months [Time frame: Baseline, 6 months]
• Blood pressure at 3 months [Time frame: Baseline, 3 months]
• Blood pressure at 6 months [Time frame: Baseline, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• UPMC Magee Womens Hospital — Pittsburgh

Identifiers

NCT: NCT07599579 · STUDY25070197

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗