MumCare: Mum's Cardiovascular Health for Life

Phase

N/A

Condition

Diabetes (Pediatric)

Vascular Diseases

High Blood Pressure (Hypertension - Pediatric)

Treatment

Access to MumCare app

Clinical Study ID

NCT05835596

478376

Ages 18-50
Female

Study Summary

The goal of this randomized clinical trial study is to test the potential benefits of eHealth-assisted follow-up after pregnancy complications that confer and increased risk for premature cardiovascular (CV) disease.

The overarching aim is to improve short- and long-term CV health in women following pregnancy complications associated with increased risk of CV disease (hypertensive disorders of pregnancy and gestational diabetes). The investigators will develop and test a novel, personalized and user co-designed digital eHealth companion ("app") and test the app in a clinical randomized control trial. The group randomized to app use will get access to the app prior to delivery or within the first weeks postpartum, whereas the control group will not get access to the app, but receive ordinary follow-up. Both groups are invited to a comprehensive cardiovascular follow-up 14-18 months post delivery.

The primary objective is to assess whether the rate of 1-year postpartum follow-up at the general practitioner's is increased with MumCare app access. Secondary objectives are to assess:

expectations of (and satisfaction with) postpartum eHealth-assisted technologies,
if health perception, sense of empowerment, quality of life, modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.

Eligibility Criteria

Inclusion

Inclusion Criteria:

An ongoing or recent pregnancy complicated by hypertensive disorder of pregnancyand/or gestational diabetes mellitus
Patient attending Oslo University Hospital, Oslo, Norway
Signed informed written consent (to be randomized to app access or not)

Exclusion

Exclusion Criteria:

Not capable of accessing and using an app downloaded on a smart phone
Not able to understand the informed consent or app instructions or content (inNorwegian, but later the study consent form and app will be translated into Englishand other languages)

Study Design

Access to MumCare app

June 18, 2024

September 30, 2029

Study Description

Cardiovascular disease (CVD) is a leading cause of premature death and morbidity in women. CVD prevention is most effective when started at subclinical stages. Preeclampsia, gestational hypertension, and gestational diabetes are female sex-specific risk factors for CVD. Postpartum follow-up programs for the primary prevention of CVD following these complications are not offered today. In the MumCare study, a randomized control trial (RCT) will test a new eHealth app that promotes a personalized cardiovascular (CV) health optimization in young women after such pregnancy complications.

The study will first assess users' expectations of eHealth-assisted follow-up following the aforementioned pregnancy complications. These users will test and help fine-tune the new MumCare app, which integrates patient self-registered health data with an educational follow-up program based on Norwegian obstetric - and the Norwegian Directorate of Health guidelines. The study will recruit women to use the MumCare app in a 1:1 RCT lasting 18 months postpartum. App use (in the active study arm) will be registered in secure IT systems.

The primary outcome for comparison between groups (women with and without app access) is the rate of 1-year postpartum follow-up with a general practitioner (as recommended in the obstetric guidelines). Secondary outcomes include user-reported outcomes (such as health empowerment and quality of life) and objective risk factors for CVD (evaluated 14-18 months postpartum in all study groups, including assessment of CV risk factors, CV function and biomarkers).

Connect with a study center

Oslo University Hospital
Oslo, 0424
Norway
Site Not Available

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