Mobile Health Program for Post-Preeclampsia Hypertension

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UPMC Magee Womens Hospital — Pittsburgh

Идентификаторы

NCT: NCT07599579 · STUDY25070197

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗