Preeclampsia Clinical Trial
Official title:
Implementing an App-based Remote Blood Pressure Monitoring Program to Reduce Health Disparities Among Women With Hypertension During Pregnancy
Verified date | September 2023 |
Source | Women and Infants Hospital of Rhode Island |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Remote postpartum blood pressure monitoring program with text messages has been shown to increase adherence to recommended postpartum blood pressure checks among those with hypertension at discharge from birth hospitalization, but these programs require medically trained professionals to respond to each individual text message. A bluetooth-enabled blood pressure cuff that synchs automatically a smartphone application that leverages Artificial Intelligence to provide tailored recommendations based on recorded blood pressure measurements--and can also provide on-demand education on hypertension--may be less costly way to provide similar support.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - a) English- or Spanish-speaking - b) maternal age >18 years old - c) smartphone ownership for remote blood pressure ascertainment - d) diagnosis of gestational hypertension, preeclampsia, or chronic hypertension at hospital discharge - e) plan to receive postpartum care at a Women & Infants Hospital (WIH)-affiliated clinic Exclusion Criteria: - a) fetal anomaly - b) prisoners - c) lack of smartphone - d) inability to consent. |
Country | Name | City | State |
---|---|---|---|
United States | Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood pressure ascertainment | Adherence to recommended blood pressure check after hospital discharge | 3-10 days postpartum | |
Secondary | postpartum readmission for hypertension or preeclampsia | Readmission rate for HTN/preeclampsia | Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia | |
Secondary | Adherence to evidence-based practice | Medication initiation/titration, postpartum blood pressure goal of <150/100 | From randomization until 6 weeks postpartum | |
Secondary | Postpartum severe maternal morbidity composite | Stroke, seizure/eclampsia, acute fatty liver of pregnancy, posterior reversible encephalopathy syndrome, pulmonary edema, heart failure, hemolysis elevated liver enzymes and low platelets, placental abruption, postpartum hemorrhage, acute kidney injury, transaminitis | From randomization until 6 weeks postpartum | |
Secondary | Agency for Healthcare Research and Quality Consumer Assessment of Healthcare Providers and Systems survey (AHRQ CAHPS) | Patient preference of treatment group | At randomization and again at 40 days postpartum | |
Secondary | Decisional Regret Scale | Extent to which participant regrets participating in a treatment group. To help interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret. | At randomization and again at 40 days postpartum |
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