Hypertension in PregnancyNCT04486170
Assessment of Postpartum Education to Improve Compliance
A study testing Education provided via a video format in people with Hypertension in Pregnancy and Postpartum Preeclampsia, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy, Postpartum Preeclampsia
- What is being tested?
- Education provided via a video format
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who do not intend to follow up at Washington Hospital Center
- Suffered from intrauterine fetal demise
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
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.
Read the 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.
- Conditions
- Hypertension in Pregnancy, Postpartum Preeclampsia
- Being tested
- Education provided via a video format
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education provided via a video formatOther
Also called Education provided in a pamphlet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education provided via a video format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with postpartum care
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
Measured: 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
Measured: This outcome will be evaluated within 6 weeks of delivery
Secondary outcomes (10)
Incidence of postpartum re-admission for hypertension related concerns
The investigators will retrospectively review if the study participants are re-admitted for hypertension related concerns
Measured: This outcome will be evaluated within 6 weeks of delivery
Incidence of postpartum labor and delivery triage visits
The investigators will retrospectively review if the study participants are evaluated in the labor and delivery triage for hypertension related concerns
Measured: This outcome will be evaluated within 6 weeks of delivery
Incidence of postpartum emergency department visits
The investigators will retrospectively review if the study participants are evaluated in the emergency department for hypertension related concerns
Measured: This outcome will be evaluated within 6 weeks of delivery
Evaluate weight (kg) change
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Measured: This outcome will be evaluated upon hospital admission
Evaluate weight (kg) change
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Measured: This outcome will be evaluated upon hospital discharge
Evaluate weight (kg) change
The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
Measured: This outcome will be evaluated within 6 week after delivery
Incidence of stroke
The investigators will retrospectively review if the study participant suffered a stroke
Measured: This outcome will be evaluated within 6 weeks of delivery
Incidence of maternal death
The investigators will retrospectively review maternal death during this study period
Measured: This outcome will be evaluated within 6 weeks of delivery
Participant satisfaction with postpartum education using likert scale
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).
Measured: This outcome will be evaluated at time of recruitment, within 48hours
Participant satisfaction with postpartum education
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.
Measured: This outcome will be evaluated at time of recruitment, within 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start14 Sep 2020
- Primary completion25 Jun 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Iqbal, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486170
- Sponsor's protocol ID
- IRB STUDY 00001865
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
- ClinicalTrials.gov ID
- NCT04486170
- Acronym / sponsor ID
- IRB STUDY 00001865
- Conditions
- Hypertension in Pregnancy, Postpartum Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Education provided via a video formatThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Women who do not intend to follow up at Washington Hospital Center
- Suffered from intrauterine fetal demise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education provided via a video formatAlso: Education provided in a pamphletThe 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 | Intervention group: Standardized video and pamphlet |
Primary outcome
Compliance with postpartum care
Time frame: This outcome will be evaluated within 10 days of discharge
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
Compliance with postpartum care
Time frame: This outcome will be evaluated within 6 weeks of delivery
The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
10 secondary outcomes
Incidence of postpartum re-admission for hypertension related concerns
Time frame: This outcome will be evaluated within 6 weeks of delivery
Incidence of postpartum labor and delivery triage visits
Time frame: This outcome will be evaluated within 6 weeks of delivery
Incidence of postpartum emergency department visits
Time frame: This outcome will be evaluated within 6 weeks of delivery
Evaluate weight (kg) change
Time frame: This outcome will be evaluated upon hospital admission
Evaluate weight (kg) change
Time frame: This outcome will be evaluated upon hospital discharge
Evaluate weight (kg) change
Time frame: This outcome will be evaluated within 6 week after delivery
Incidence of stroke
Time frame: This outcome will be evaluated within 6 weeks of delivery
Incidence of maternal death
Time frame: This outcome will be evaluated within 6 weeks of delivery
Participant satisfaction with postpartum education using likert scale
Time frame: This outcome will be evaluated at time of recruitment, within 48hours
Participant satisfaction with postpartum education
Time frame: This outcome will be evaluated at time of recruitment, within 48hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Iqbal, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education provided via a video format in people with Hypertension in Pregnancy and Postpartum Preeclampsia, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with postpartum care (time frame: This outcome will be evaluated within 10 days of discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.