Assessment of Postpartum Education to Improve Compliance

NCT04486170 | Completed

• 1 other identifier: IRB STUDY 00001865
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single centered randomized control study for postpartum patients diagnosed with hypertension. Participants that meet inclusion criteria will be approached while they are inpatient. After enrollment, all study subjects will receive an automated blood pressure cuff and instructions on how to use it. Study participants in the intervention group will be provided with educational material. The investigators hypothesize education in postpartum women with hypertension can improve patient compliance with attendance at postpartum care appointments.

Conditions

Hypertension in Pregnancy; Postpartum Preeclampsia

Outcome Measures

Primary Outcomes (2)

• Compliance with postpartum care

  The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment

  This outcome will be evaluated within 10 days of discharge

• Compliance with postpartum care

  The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment

  This outcome will be evaluated within 6 weeks of delivery

Secondary Outcomes (10)

• Incidence of postpartum re-admission for hypertension related concerns

  This outcome will be evaluated within 6 weeks of delivery

• Incidence of postpartum labor and delivery triage visits

  This outcome will be evaluated within 6 weeks of delivery

• Incidence of postpartum emergency department visits

  This outcome will be evaluated within 6 weeks of delivery

• Evaluate weight (kg) change

  This outcome will be evaluated upon hospital admission

• Evaluate weight (kg) change

  This outcome will be evaluated upon hospital discharge

Study Arms (2)

Control group: Current hospital education practices

NO INTERVENTION

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.

Intervention group: Standardized video and pamphlet

EXPERIMENTAL

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.

Other: Education provided via a video format

Interventions

Education provided via a video format OTHER

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.

Also known as: Education provided in a pamphlet

Intervention group: Standardized video and pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who do not intend to follow up at Washington Hospital Center
• Suffered from intrauterine fetal demise

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sara Iqbal, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 24, 2020
• Study Start: September 14, 2020
• Primary Completion: June 25, 2021
• Study Completion: December 15, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)