Health TrialsbyHealthPanel

Mobile Health Program for Post-Preeclampsia Hypertension

ConditionsHypertension (HTN)PreeclampsiaHypertensive Disorders of Pregnancy (HDP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coaching application

    Behavioral

    A digital application for providing education and support for home-based blood pressure monitoring.

  • Home-based blood pressure monitoring

    Behavioral

    Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

  • WebMD

    Other intervention

    Smartphone-based application for health education and/or monitoring.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Coaching Application + HBPMExperimental treatment 2 interventions
Group B: Enhanced usual care with WebMDActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in systolic blood pressure from baseline to 3 months

Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.

Time frame
Baseline, 3 Months

Secondary outcomes

1

Change in diastolic BP and mean arterial pressure from baseline to 3 months

Change in diastolic BP and mean arterial pressure from baseline to 3 months

Time frame
Baseline, 3 months
2

Adherence to antihypertensive medications at 3 months and 6 months

Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.

Time frame
Baseline, 6 months
3

Proportion with BP controlled <130/80 mmHg at 3 months and 6 months

Time frame
Baseline, 3 months, 6 months
4

Adherence to home blood pressure monitoring

Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence.

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

McKamish Family Foundation

Collaborator

Source ClinicalTrials.gov
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