Decision Aid for Hypertensive Disorders of Pregnancy

Overseen By Lauren Theilen, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Cardiovascular disease, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Decision aid for Hypertensive Disorders of Pregnancy?

Research shows that decision aids can help pregnant women feel less anxious, more informed, and more satisfied with their choices. They have been positively evaluated in other conditions like hypertension, suggesting they might also be helpful for hypertensive disorders during pregnancy. ^{1 2 3 4 5}

Is the decision aid safe for use in humans?

The decision aid is a tool designed to help people make informed health decisions by providing personalized information and guidance. It has been positively evaluated by patients and healthcare professionals for conditions like hypertension, suggesting it is safe to use as a decision-making tool. ^{4 6 7 8 9}

How does the Decision Aid for Hypertensive Disorders of Pregnancy treatment differ from other treatments?

The Decision Aid for Hypertensive Disorders of Pregnancy is unique because it focuses on shared decision-making between pregnant women and their healthcare providers, helping them understand risks and benefits to make informed choices together. Unlike traditional treatments that may not involve patient preferences, this approach reduces anxiety and decisional conflict by providing tailored information and support. ^{3 8 10 11 12}

Eligibility Criteria

This trial is for English or Spanish-speaking women who recently gave birth at the University of Utah and had high blood pressure issues during pregnancy. It's not open to those with a history of cardiovascular diseases like heart attack or stroke, or cognitive/vision impairments that would prevent understanding the study materials.

Inclusion Criteria

I can speak and read English or Spanish.

Written informed consent obtained

You recently had a pregnancy with high blood pressure complications at the University of Utah during your current hospital stay.

Exclusion Criteria

I have a history of heart or blood vessel disease.

You have trouble thinking clearly or seeing well, which makes it hard for you to talk or understand information.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a decision aid to improve knowledge and self-efficacy regarding cardiovascular disease prevention during the postpartum period

6-8 weeks

Postpartum visits as per standard care

Follow-up

Participants are monitored for decisional conflict and engagement in cardiovascular preventive care

4 weeks

Treatment Details

Interventions

• Decision aid

Trial Overview The study is testing a decision aid designed to help these new mothers engage in preventive care against heart disease. Since they're at higher risk after having high blood pressure complications in pregnancy, this tool aims to guide them towards better heart health.

Participant Groups

Group I: Decision aid Experimental Treatment 1 Intervention

Participants will use the decision aid in the postpartum period

Group II: Usual care Active Control 1 Intervention

Participants will receive standard postpartum care

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

A generic tool for development of decision aids based on clinical practice guidelines. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Three-year follow-up of a factorial randomised controlled trial of two decision aids for newly diagnosed hypertensive patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Helping pregnant women make better decisions: a systematic review of the benefits of patient decision aids in obstetrics. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A computerised guidance tree (decision aid) for hypertension, based on decision analysis: development and preliminary evaluation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Patient Decision Aids to Engage Adults in Treatment or Screening Decisions. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The development of a patient decision aid to reduce decisional conflict about antidepressant use in pregnancy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effectiveness of decision aids for pregnancy related decision-making in women with pre-pregnancy morbidity; systematic review and meta-analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Developing a decision aid to support informed choices for newly diagnosed patients with localized prostate cancer. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Decision aid tools to support women's decision making in pregnancy and birth: a systematic review and meta-analysis. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Watchful waiting or induction of labour--a matter of informed choice: identification, analysis and critical appraisal of decision aids and patient information regarding care options for women with uncomplicated singleton late and post term pregnancies: a review. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Patient Decision Aids to Facilitate Shared Decision Making in Obstetrics and Gynecology: A Systematic Review and Meta-analysis. [2021]