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| Name | Class |
|---|---|
| McKamish Family Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching Application + HBPM | Experimental | 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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| Enhanced usual care with WebMD | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching application | Behavioral | A digital application for providing education and support for home-based blood pressure monitoring. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months |
| Adherence to antihypertensive medications at 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Travis | Contact | 4126413295 | travisam@upmc.edu | |
| Samantha Bryan | Contact | 412-641-1363 | myslinskisg@mwri.magee.edu |
| Name | Affiliation | Role |
|---|---|---|
| Malamo Countouris, MD, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
The study team will share all of the individual participant data collected during the trial, after deidentification.
The data will be available 12 months following publication of the primary results of this trial.
Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator at countourisme@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be provided directly by the study investigators. Costs associated with producing datasets and analysis will be the responsibility of investigators seeking the data.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
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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
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| Home-based blood pressure monitoring | Behavioral | Device for measuring blood pressure at home with blue tooth connectivity for automated collection. |
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| WebMD | Other | Smartphone-based application for health education and/or monitoring. |
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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.
| Baseline, 6 months |
| Proportion with BP controlled <130/80 mmHg at 3 months and 6 months | 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. | 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 | 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 | 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 | Baseline, 6 months |
| Blood pressure at 3 months | Systolic, diastolic, and mean arterial blood pressure at 3 months | Baseline, 3 months |
| Blood pressure at 6 months | Systolic, diastolic, and mean arterial blood pressure at 6 months | Baseline, 6 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |