Hypertension (HTN), Hypertensive Disorders of Pregnancy (HDP), Preeclampsia
Conditions
Keywords
hypertension, preeclampsia, coaching, home blood pressure monitoring
Brief summary
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
BEHAVIORALCoaching application
A digital application for providing education and support for home-based blood pressure monitoring.
BEHAVIORALHome-based blood pressure monitoring
Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
OTHERWebMD
Smartphone-based application for health education and/or monitoring.
Sponsors
University of Pittsburgh
McKamish Family Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure from baseline to 3 months | Baseline, 3 Months | Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic BP and mean arterial pressure from baseline to 3 months | Baseline, 3 months | Change in diastolic BP and mean arterial pressure from baseline to 3 months |
| Adherence to antihypertensive medications at 3 months and 6 months | Baseline, 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. |
| Proportion with BP controlled <130/80 mmHg at 3 months and 6 months | Baseline, 3 months, 6 months | — |
| Adherence to home blood pressure monitoring | Baseline, 3 months | Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence. |
| Feasibility of study measured using enrollment, survey completion, and retention of participants | Baseline, 3 Month, 6 Month | Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study |
| Durable change in systolic blood pressure measures at 6 months | Baseline, 6 months | Durable change in SBP measures at 6 months between intervention and usual care arms |
| Durable change in diastolic BP measures at 6 months | Baseline, 6 months | Durable change in DBP measures at 6 months between intervention and usual care arms |
| Blood pressure at 3 months | Baseline, 3 months | Systolic, diastolic, and mean arterial blood pressure at 3 months |
| Blood pressure at 6 months | Baseline, 6 months | Systolic, diastolic, and mean arterial blood pressure at 6 months |
Countries
United States
Contacts
CONTACTAmy Travis
CONTACTSamantha Bryan
PRINCIPAL_INVESTIGATORMalamo Countouris, MD, MS
University of Pittsburgh
Outcome results
None listed