MumCare: Mum's Cardiovascular Health for Life

Обзор

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: 1. expectations of (and satisfaction with) postpartum eHealth-assisted technologies, 2. if health perception, sense of empowerment (self-management evaluation and general self-efficacy), modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight, physical activity), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.

Подробное описание

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 objective risk factors for CVD (evaluated 14-18 months postpartum in all study groups, including assessment of CV risk factors, CV function and biomarkers).

Вмешательства

• Устройство Access to MumCare app
  Education, push warning to book cardiovascular health follow-up at own general practitioner, registration of BP, blood sugars and lipids

Первичные конечные точки

• General Practitioner attendance 1 year postpartum [Срок оценки: 1 year postpartum]

Вторичные конечные точки (12)

• Patient Reported Outcome Measures (PROM); heiQ [Срок оценки: 12-14 months postpartum]
• Patient Reported Outcome Measures (PROM); GSE [Срок оценки: 12-14 months postpartum]
• Patient Reported Outcome Measures (PROM); IPAQ [Срок оценки: 12-14 months postpartum]
• System usability scale (SUS) questionnaire [Срок оценки: 12-14 months postpartum]
• Qualitative interviews of users and their General Practiotioner [Срок оценки: 14-18 montths postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: Blood pressure [Срок оценки: 14-18 months postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: BMI [Срок оценки: 14-18 months postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: HbA1c [Срок оценки: 14-18 months postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: HDL [Срок оценки: 14-18 months postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: Total cholesterol [Срок оценки: 14-18 months postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: LDL cholesterol [Срок оценки: 14-18 months postpartum]
• Clinical cardiovascular follow-up at recruitment hospital: fTG [Срок оценки: 14-18 months postpartum]

Критерии участия

Критерии включения

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

Критерии исключения

• Prepregnancy diagnosis of hypertension and/or diabetes mellitus (type I/II) (as these groups likely receive adequate cardiovascular follow-up )
• Prepregnancy diagnosis of kidney or cardiovascular disease (as these groups likely receive adequate cardiovascular follow-up )
• 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 (The patient information/informed study consent is available in in Norwegian and English, as is the MumCare app. The patient can herself chose either language in the appp, and easily convert from the Norwegian to the English version (and vice versa), without losing registered health data).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Норвегия · 1 центр

• Oslo University Hospital — Oslo

Публикации

• Staff AC, Sjaavik AD, Noll J, Sugulle M, Fiska B, Klovning A, Estensen ME, Dechend R, Waldum AH, Solbraekke KN, Aasbo G. Co-creation of a mobile health program (MumCare) for preventing maternal cardiovascular disease after pregnancy complications. Front Glob Womens Health. 2026 Apr 30;7:1717203. doi: 10.3389/fgwh.2026.1717203. eCollection 2026. PMID 42145904

Идентификаторы

NCT: NCT05835596 · 478376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗