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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07486375
Enrollment
99
Registered
2026-03-20
Start date
2023-02-15
Completion date
2023-12-25
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Disorders of Pregnancy (HDP), Postpartum Hypertension

Brief summary

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.

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).

Interventions

BEHAVIORALPostpartum Hypertension Self-Management App (PHSMA)

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.

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure ControlBaseline to 6 weeks postpartumChange 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.
Perceived StressBaseline to 6 weeks postpartumChange 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.
Postpartum StressBaseline to 6 weeks postpartumChange 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.
Postpartum depressionBaseline to 6 weeks postpartumChange 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.

Secondary

MeasureTime frameDescription
Health-Promoting Lifestyle BehaviorsBaseline to 6 weeks postpartumChange 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.
General Self-Efficacy Scale (GSES)Baseline to 6 weeks postpartumChange in general self-efficacy among postpartum women with hypertensive disorders of pregnancy (HDP). General self-efficacy was measured using the General Self-Efficacy Scale (GSES), a 10-item instrument that assesses an individual's perceived ability to cope with difficult situations and challenges. Each item is rated on a 4-point Likert scale, with total scores ranging from 10 to 40. Higher scores indicate greater general self-efficacy.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026