- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07486375
Self-Management App for Blood Pressure and Well-Being in Postpartum Women With Hypertensive Disorders of Pregnancy
Effects of a Self-management App on Blood Pressure, Stress, and Depression and Health-Promoting Lifestyles in Postpartum Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial
Hypertensive disorders of pregnancy (HDP) are a major cause of maternal morbidity and may continue to affect women after childbirth. Effective postpartum self-management is important for controlling blood pressure (BP) and improving overall health. eHealth applications may provide convenient tools to support self-monitoring and promote healthy behaviors.
The purpose of this randomized controlled trial is to evaluate the effectiveness of a self-management application for postpartum women with hypertensive disorders of pregnancy (HDP). Participants are randomly assigned to either a self-management app intervention group or a usual care group. The study assesses whether the application improves blood pressure (BP)control, psychological well-being (stress and depression), and health-promoting lifestyle behaviors among postpartum women.
Study Overview
Status
Intervention / Treatment
Detailed Description
Hypertensive disorders of pregnancy (HDP) are among the leading causes of maternal morbidity worldwide and may have persistent health effects during the postpartum period. Women with HDP are at increased risk of sustained hypertension and adverse cardiovascular outcomes after childbirth. Effective postpartum self-management, including blood pressure (BP) monitoring, psychological well-being, and the adoption of healthy lifestyle behaviors, is essential for improving long-term maternal health.
eHealth technologies have been increasingly used to support patient self-management by providing accessible health information, self-monitoring tools, and behavioral support. However, evidence regarding mobile applications specifically designed for postpartum women with HDP remains limited.
This randomized controlled trial evaluates the effectiveness of a self-management mobile application designed for postpartum women with hypertensive disorders of pregnancy (HDP). Eligible participants are randomly assigned to either an intervention group receiving the self-management application or a usual care control group. The intervention supports blood pressure (BP) monitoring, health education, and lifestyle management during the postpartum period.
This study aim to investigate the effectiveness of a self-management mobile App on blood pressure, stress, depression, and health-promoting lifestyles among postpartum women with hypertensive disorders of pregnancy (HDP).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan City
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Tainan, Tainan City, Taiwan, 704
- National Cheng Kung University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Postpartum women aged 20 years or older.
- Diagnosed with hypertensive disorders of pregnancy (HDP).
- Have access to the internet via a mobile phone.
- Own a home blood pressure monitor.
Exclusion Criteria:
- Diagnosed with psychiatric disorders.
- Intrauterine fetal death in the current pregnancy.
- Infants with congenital malformations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Self-Management App Group
Participants in this group receive access to the self-management application to support postpartum health management, including blood pressure monitoring, health education, lifestyle guidance, and professional consultation during the postpartum period.
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The Postpartum Hypertension Self-Management App (PHSMA) was developed by our research team (Chang et al., 2023 ), and it is suitable for iOS and Android systems.
Designed to enhance knowledge and support self-management in postpartum women with HDP.
The app allows users to upload, monitor, and review personal health records related to postpartum hypertension.
The app contents were designed by a comprehensive literature review and expert consensus, addressing key needs in postpartum HDP care, including continuity of care, medication and emotional management, and access to health information and professional consultation.
The PHSMA includes six interactive modules: (1) HDP knowledge, (2) Postpartum monitoring and self-management of physiological data, (3) Medication management, (4) Nursing care and mental health education for HDP, (5) Lifestyle and health promotion strategies, and (6) Consulting platform for healthcare professionals.
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No Intervention: Usual Care Group
Participants in this group received routine postpartum care according to standard clinical practice.
They used paper-based records to monitor and document postpartum blood pressure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood Pressure Control
Time Frame: Baseline to 6 weeks postpartum
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Change in systolic and diastolic blood pressure (BP) among postpartum women with hypertensive disorders of pregnancy (HDP).
Using an electric sphygmomanometer, women were instructed to measure their BP twice daily, 7-10 am and 5-8 pm after discharge.
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Baseline to 6 weeks postpartum
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Perceived Stress
Time Frame: Baseline to 6 weeks postpartum
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Change in perceived stress levels among postpartum women.
Perceived stress was measured using the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses perceived stress over the past month.
Each item is rated on a 5-point Likert scale from 0 (never) to 4 (almost always), with total scores ranging from 0 to 40.
Higher scores indicate greater perceived stress.
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Baseline to 6 weeks postpartum
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Postpartum Stress
Time Frame: Baseline to 6 weeks postpartum
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Change in postpartum stress levels among postpartum women.
Postpartum stress was measured using the Hung Postpartum Stress Scale (HPPS), a 62-item instrument designed to assess postpartum stress during the six-week postpartum period.
Each item is rated on a 5-point Likert scale from 1 (not at all) to 5 (always), with total scores ranging from 62 to 310.
Higher scores indicate higher levels of postpartum stress.
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Baseline to 6 weeks postpartum
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Postpartum depression
Time Frame: Baseline to 6 weeks postpartum
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Change in postpartum depressive symptoms. Depressive symptoms were measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire that assesses depressive symptoms over the past seven days. Each item is scored on a 4-point Likert scale from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate more severe depressive symptoms. |
Baseline to 6 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health-Promoting Lifestyle Behaviors
Time Frame: Baseline to 6 weeks postpartum
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Change in health-promoting lifestyle behaviors among postpartum women with hypertensive disorders of pregnancy (HDP).
Health-promoting lifestyle behaviors were measured using the Health-Promoting Lifestyle Profile Short Scale (HPLP-S), a 24-item instrument that assesses six dimensions: self-actualization, health responsibility, physical activity, nutrition, interpersonal support, and stress management.
Each item is rated on a 4-point Likert scale, with total scores ranging from 24 to 96.
Higher scores indicate better health-promoting lifestyle behaviors.
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Baseline to 6 weeks postpartum
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Collaborators and Investigators
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
Other Study ID Numbers
- B-ER-111-434
- TWNA-1121015 (Other Grant/Funding Number: Taiwan Nurses Association)
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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