- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486170
Assessment of Postpartum Education to Improve Compliance
Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study group: postpartum women with a diagnosis of either chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, chronic hypertension with superimposed preeclampsia with and without severe features.
Recruitment: postpartum patients that meet the inclusion criteria will be approached postpartum while they are still hospitalized. Once the study subjects are enrolled, they will receive the same automatic blood pressure cuff and basic teaching on how to use it. All study subjects will be asked to check their blood pressure once a day. The study subjects will be advised that if systolic blood pressure is > 160 or the diastolic blood pressure >110, the study subjects are asked to remain seated and repeat the BP measurement in 15 minutes, if still elevated the study subject will be advised to call labor and delivery or proceed to labor and delivery triage for further evaluation. All study subjects will be asked to follow up for a blood pressure check 3-10 days after discharge home. All study subjects will be weighed prior to discharge.
The study subject is then randomized to the control or intervention group. Both groups will receive a survey. After the intervention group undergoes the educational component, this will be the last time the study subjects meet with the investigator.
The data will be collected on an excel spreadsheet. Patient identifiers will be removed once the study is completed. However, de-identified data may be used for future studies. The database will be password protected on an excel spreadsheet and secured behind the Medstar Washington Hospital Center firewall computers. Access to these databases is restricted to the PI and the co-investigators. The data will be statistically analyzed in order to answer the primary and secondary outcomes.
Power analysis: At Washington hospital center, the current attendance within 10 day postpartum follow up appointments is 40% and at the 6 week appointment it is 70%. Based on this data the investigator wants to evaluate if this postpartum education intervention can cause a 100% difference in attendance within 10 days postpartum: 40% attendance which is the current attendance rate (control) versus 80% (goal for the intervention group): enrollment of 46 patients is required.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postpartum with diagnosis of Hypertension is defined as chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, chronic hypertension with superimposed preeclampsia with and without severe features.
- At least 18 years or older
- English speaking patient and also able to read in English
- Plan to receive postpartum care at Washington Hospital Center
Exclusion Criteria:
- Women who do not intend to follow up at Washington Hospital Center
- Suffered from intrauterine fetal demise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control group: Current hospital education practices
The control group will receive standard of care postpartum educational materials provided by the nursing and resident physician staff.
The will be asked to complete a brief questionnaire to determine if they would be interested in receiving education in a video formal.
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Experimental: Intervention group: Standardized video and pamphlet
The subjects enrolled in the invention group will be shown a 5 minute educational video on hypertension in the postpartum period.
The patients will be shown the video on the ipad while they are in the comfort of their room.
They will also be provided with a pamphlet with similar information that was discussed in the video.
They will also be asked to complete a brief, anonymous survey to assess patient satisfaction with the video shown, no patient identifiers will be collected.
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The intervention group will be shown a 5 minute educational video on hypertension in the postpartum period.
The patients will be shown the video on the ipad while they are in the comfort of their room and the investigator will step outside.
At the conclusion of the video, the investigator will return into the patient room and provide a pamphlet with similar information that was discussed in the video for them to take home.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance with postpartum care
Time Frame: This outcome will be evaluated within 10 days of discharge
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The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
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This outcome will be evaluated within 10 days of discharge
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Compliance with postpartum care
Time Frame: This outcome will be evaluated within 6 weeks of delivery
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The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
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This outcome will be evaluated within 6 weeks of delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postpartum re-admission for hypertension related concerns
Time Frame: This outcome will be evaluated within 6 weeks of delivery
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The investigators will retrospectively review if the study participants are re-admitted for hypertension related concerns
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This outcome will be evaluated within 6 weeks of delivery
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Incidence of postpartum labor and delivery triage visits
Time Frame: This outcome will be evaluated within 6 weeks of delivery
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The investigators will retrospectively review if the study participants are evaluated in the labor and delivery triage for hypertension related concerns
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This outcome will be evaluated within 6 weeks of delivery
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Incidence of postpartum emergency department visits
Time Frame: This outcome will be evaluated within 6 weeks of delivery
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The investigators will retrospectively review if the study participants are evaluated in the emergency department for hypertension related concerns
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This outcome will be evaluated within 6 weeks of delivery
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Evaluate weight (kg) change
Time Frame: This outcome will be evaluated upon hospital admission
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The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
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This outcome will be evaluated upon hospital admission
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Evaluate weight (kg) change
Time Frame: This outcome will be evaluated upon hospital discharge
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The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
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This outcome will be evaluated upon hospital discharge
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Evaluate weight (kg) change
Time Frame: This outcome will be evaluated within 6 week after delivery
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The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
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This outcome will be evaluated within 6 week after delivery
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Incidence of stroke
Time Frame: This outcome will be evaluated within 6 weeks of delivery
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The investigators will retrospectively review if the study participant suffered a stroke
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This outcome will be evaluated within 6 weeks of delivery
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Incidence of maternal death
Time Frame: This outcome will be evaluated within 6 weeks of delivery
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The investigators will retrospectively review maternal death during this study period
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This outcome will be evaluated within 6 weeks of delivery
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Participant satisfaction with postpartum education using likert scale
Time Frame: This outcome will be evaluated at time of recruitment, within 48hours
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A likert scale survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups.
The scale is reported as follows: 1 (Strongly disagree) 2 3 (neutral) 4 5 (strongly agree).
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This outcome will be evaluated at time of recruitment, within 48hours
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Participant satisfaction with postpartum education
Time Frame: This outcome will be evaluated at time of recruitment, within 48hours
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A survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups.
The responses are either Yes or No.
For most questions, answering yes would be a favorable response.
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This outcome will be evaluated at time of recruitment, within 48hours
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Collaborators and Investigators
Investigators
- Principal Investigator: Sara Iqbal, MD, MedStar Washington Hospital Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB STUDY 00001865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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