Mobile Health Program for Post-Preeclampsia Hypertension

N/ANot Yet RecruitingNCT07599579

University of Pittsburgh50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension (HTN)Preeclampsia Hypertensive Disorders of Pregnancy (HDP)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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

Feasibility of study measured using enrollment, survey completion, and retention of participants

Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study

Time frame: Baseline, 3 Month, 6 Month

Durable change in systolic blood pressure measures at 6 months

Durable change in SBP measures at 6 months between intervention and usual care arms

Time frame: Baseline, 6 months

Durable change in diastolic BP measures at 6 months

Durable change in DBP measures at 6 months between intervention and usual care arms

Time frame: Baseline, 6 months

Blood pressure at 3 months

Systolic, diastolic, and mean arterial blood pressure at 3 months

Time frame: Baseline, 3 months

Blood pressure at 6 months

Systolic, diastolic, and mean arterial blood pressure at 6 months

Time frame: Baseline, 6 months

Mobile Health Program for Post-Preeclampsia Hypertension

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts