Postpartum Hypertension: Remote Patient Monitoring
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|ClinicalTrials.gov Identifier: NCT03111095|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pregnancy-Induced||Other: Mobile Health||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Patient Monitoring- Telehealth for Management of Women With Postpartum Hypertension|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||June 8, 2018|
|Estimated Study Completion Date :||June 8, 2019|
Experimental: Mobile Health Participants
Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Other: Mobile Health
Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.
No Intervention: Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
- Is remote patient monitoring program an effective model of care to improve patient satisfaction regarding management of postpartum hypertension? [ Time Frame: Up to 12 months ]Conduct an initial phase study for postpartum women at risk for severe hypertension to estimate the rates of willingness to participate in and utilize remote mobile health applications to monitor home blood pressures and weights, medication adherence after hospital discharge, to inform a trial to decrease postpartum maternal morbidity and readmission.
- Cost effective analysis on remote patient monitoring for postpartum hypertension. [ Time Frame: Up to 12 months ]Perform a cost effectiveness modeling will be performed to determine whether it is costeffective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy. Primary outcomes examined will include cost and readmissions.
- Maternal outcomes in remote patient monitoring vs standard surveillance. [ Time Frame: Up to 12 months ]Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the cohort of patients with hypertension related disorders discharged with routine care. Outcomes of interest: Incidence of severe hypertension (SBP >150/DBP >105), hospital readmission, initiation of antihypertensive medication, unexpected outpatient clinic/emergency room visit, compliance with medications, compliance with outpatient blood pressure surveillance or scheduled visits, death, stroke.
- Difference in blood pressures intrapartum and postpartum. [ Time Frame: Up to 12 months ]Estimate standard deviations of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) in the intrapartum compared to 24-96 hours postpartum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111095
|United States, Wisconsin|
|UnityPoint Health- Meriter Hospital|
|Madison, Wisconsin, United States, 53715|
|Principal Investigator:||Kara Hoppe, DO||Clinical Assistant Professor|