Management of cardiovascular disease using an mHealth tool: a randomized clinical trial.
Si-Hyuck Kang, Hyunyoung Baek, Jihoon Cho...
https://pubmed.ncbi.nlm.nih.gov/34862449Actively Recruiting
Led by Seoul National University Hospital · Updated on 2023-12-21
580
Participants Needed
1
Research Sites
43 weeks
Total Duration
Researchers are evaluating the use of a mobile application called Heart4U to help pregnant women with hypertensive cardiovascular conditions manage their risk factors. The study aims to assess how effective this self-management approach is compared to usual care. It focuses on pregnant individuals diagnosed with hypertensive disorders of pregnancy, including chronic hypertension, gestational hypertension, preeclampsia, and superimposed preeclampsia, as well as those at elevated risk for these conditions. Participants are randomly assigned to either an app group or a usual care group. The app group receives help installing and learning to use Heart4U, which integrates with the hospital's electronic medical records. Both groups continue to receive guideline-based prenatal care and active treatment as usual. Follow-up occurs at each obstetric visit before delivery and again one month postpartum. Throughout the study, participants will have their systolic blood pressure monitored from enrollment through one month after delivery. Researchers will also track other outcomes such as blood pressure trends, obstetric results, body mass index, recorded step counts, and depression assessments. The study includes safety monitoring and aims to understand the app's role in managing hypertensive disorders during pregnancy. Participation lasts from enrollment through the postpartum follow-up period.
CONDITIONS
mHealth for Hypertensive Disorder of Pregnancy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until one month postpartum
Participants either use the Heart4U mobile app with assistance from the research team or continue with guideline-based prenatal care to manage hypertensive disorders of pregnancy.
Visits as per routine prenatal care plus app usage monitoring for the app group
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463707
Actively Recruiting
J
Jung-Won Suh, MD
H
Hye-Jin Kim, RN
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Si-Hyuck Kang, Hyunyoung Baek, Jihoon Cho...
https://pubmed.ncbi.nlm.nih.gov/34862449Ju-Seung Kwun, Jina Choi, Yeonyee E Yoon...
https://pubmed.ncbi.nlm.nih.gov/38956675