Back to resultsSTAMPP-HTN in a High-risk Rural Population of Women
Primary Purpose
Hypertension in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Blood Pressure Telemonitoring
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension in Pregnancy focused on measuring Hypertension, Blood Pressure, Post-Partum, Telemonitoring
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
- Hospitalized for delivery with a hypertensive disorder of pregnancy as defined by ACOG 2019 Guidelines (chronic hypertension, HELLP syndrome, eclampsia, preeclampsia, gestational hypertension or new onset postpartum hypertension).
- Ability to understand English or Spanish
- Reliable access to the Internet and a Bluetooth mobile device
- Willingness to download Omron Connect App and ability to use blood pressure monitor
Exclusion Criteria:
- Does not meet Inclusion criteria
- Postpartum or operative complication that prolongs hospital stay beyond postpartum day 10.
- Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.
Sites / Locations
- University of MS Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote Surveillance
Arm Description
Women will use the home blood pressure monitoring device to record their blood pressure everyday for the first postpartum week, and then weekly until postpartum week 6.
Outcomes
Primary Outcome Measures
Determine if HBPT decreases the severity of postpartum hypertension complication
Postpartum outcomes between women being monitored to those from the previous year who received no postpartum blood pressure monitoring will be compared. Women will be monitored and we measure Systolic, Diastolic and Mean arterial pressure and to see if HPBT decreases the severity of postpartum hypertension from previous baseline measurements from women who had no interventions. Percentages of patients with controlled blood pressure at each time point will be compared to previous BP measurements.
Secondary Outcome Measures
Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women
A 9-question survey will be given before any hypertension education is conducted with study participants and again at the end of the 6-week study. The pre-test and post-test will measure if women are more knowledgeable of how to monitor postpartum blood pressure. We will calculate test scores and knowledge based on increase or decrease of correct answers after participants received education and training.
Assess compliance using HBPT and adherence to blood pressure medication
Study completion records (per week) will be compared with study covariates (i.e. maternal race, age, parity). The measurement of compliance across different subcategories will determine what population, race and age group is most compliant. Percentage of women who are correctly taking medication will be calculated.
Full Information
NCT ID
NCT04570124
First Posted
September 17, 2020
Last Updated
December 28, 2022
Sponsor
University of Mississippi Medical Center
Collaborators
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04570124
Brief Title
STAMPP-HTN in a High-risk Rural Population of Women
Official Title
Implementing the Systemic Treatment and Management of Postpartum Hypertension (STAMPP-HTN) Bundle in a High-risk Mississippi Population
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if monitored blood pressure paired with education reduces maternal mortality and morbidity during the post-partum period in a high-risk rural population of women.
Detailed Description
Women with hypertension during pregnancy are at an increased risk of maternal mortality (death during or within 42 days of termination of pregnancy) and hypertension related morbidity. Black women, women with lower education and less access to health care resources also have increased maternal mortality and morbidity. This project will use Bluetooth enabled blood pressure devices to monitor blood pressure in a population of postpartum women at increased risk for maternal mortality and morbidity. We will compare the number of postpartum hypertensive incidences and severities to a population of women who did not have a postpartum blood pressure control intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
Hypertension, Blood Pressure, Post-Partum, Telemonitoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Surveillance
Arm Type
Experimental
Arm Description
Women will use the home blood pressure monitoring device to record their blood pressure everyday for the first postpartum week, and then weekly until postpartum week 6.
Intervention Type
Device
Intervention Name(s)
Home Blood Pressure Telemonitoring
Intervention Description
Women will complete a 9-question survey (pre-education) prior to discharge and will go over an education video a study team member. Once discharged, women will be asked to measure their blood pressure daily for the first postpartum week, and then weekly until postpartum week 6. Women who have a doctor's visit scheduled during the first 10 days, a member of the study team will meet them there to assess blood pressure and answer any questions. Women who do not have a visit scheduled they will have a telehealth visit during days 8-10 to complete the same assessments. At the final visit, participants will measure their blood pressure via HBPT, prior to returning the unit, complete a post-education questionnaire, a post-study questionnaire and have any questions or concerns addressed.
Primary Outcome Measure Information:
Title
Determine if HBPT decreases the severity of postpartum hypertension complication
Description
Postpartum outcomes between women being monitored to those from the previous year who received no postpartum blood pressure monitoring will be compared. Women will be monitored and we measure Systolic, Diastolic and Mean arterial pressure and to see if HPBT decreases the severity of postpartum hypertension from previous baseline measurements from women who had no interventions. Percentages of patients with controlled blood pressure at each time point will be compared to previous BP measurements.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women
Description
A 9-question survey will be given before any hypertension education is conducted with study participants and again at the end of the 6-week study. The pre-test and post-test will measure if women are more knowledgeable of how to monitor postpartum blood pressure. We will calculate test scores and knowledge based on increase or decrease of correct answers after participants received education and training.
Time Frame
9 months
Title
Assess compliance using HBPT and adherence to blood pressure medication
Description
Study completion records (per week) will be compared with study covariates (i.e. maternal race, age, parity). The measurement of compliance across different subcategories will determine what population, race and age group is most compliant. Percentage of women who are correctly taking medication will be calculated.
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
Hospitalized for delivery with a hypertensive disorder of pregnancy as defined by ACOG 2019 Guidelines (chronic hypertension, HELLP syndrome, eclampsia, preeclampsia, gestational hypertension or new onset postpartum hypertension).
Ability to understand English or Spanish
Reliable access to the Internet and a Bluetooth mobile device
Willingness to download Omron Connect App and ability to use blood pressure monitor
Exclusion Criteria:
Does not meet Inclusion criteria
Postpartum or operative complication that prolongs hospital stay beyond postpartum day 10.
Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kedra Wallace, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of MS Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All women will receive a de-identified laminated notecard that has their study results (Type of hypertensive pregnancy, gestational age at delivery, discharged and current blood pressure medication, last study blood pressure, and readmission status) on it that can be shared with any new provider (including non-obstetrical). As stated in the study consent, a letter outlining the same information will also be sent to the obstetrician listed in the patient's medical record
IPD Sharing Time Frame
Within 7 days of study completion each participant will receive their personal data as outlined in the study consent.
IPD Sharing Access Criteria
Each patient will be mailed their information.
Learn more about this trial
STAMPP-HTN in a High-risk Rural Population of Women
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