Clinical trial NCT05835596: MumCare: Mum's Cardiovascular Health for Life
Official title: MumCare: Mum's Cardiovascular Health for Life
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertensive Disorder of Pregnancy
Preeclampsia
Gestational Hypertension
Gestational Diabetes
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian SIDS and Stillbirth Society
name: University of Oslo
First posted: 2023-04-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Women are ranomized to MumCare app access or not for the 14-18 month intervention time
Primary purpose: SUPPORTIVE_CARE

Brief 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:

1. expectations of (and satisfaction with) postpartum eHealth-assisted technologies,
2. 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* 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)

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 (in Norwegian, but later the study consent form and app will be translated into English and other languages)

Primary outcomes:
measure: General Practitioner attendance 1 year postpartum
timeFrame: 1 year postpartum
Secondary outcomes:
measure: Patient Reported Outcome Measures (PROM); SF-36
timeFrame: 13-14 months postpartum
measure: Patient Reported Outcome Measures (PROM); heiQ
timeFrame: 13-14 months postpartum
measure: Patient Reported Outcome Measures (PROM); GSE
timeFrame: 13-14 months postpartum
measure: Patient Reported Outcome Measures (PROM); SOC-13
timeFrame: 13-14 months postpartum
measure: Patient Reported Outcome Measures (PROM); EPDS
timeFrame: 13-14 months postpartum
measure: Qualitative interviews of users and their General Practiotioner
timeFrame: 13-14 montths postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: Blood pressure
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: BMI
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: HbA1c
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: HDL
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: Total cholesterol
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: LDL cholesterol
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: fTG
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: ApoB
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: Apo A1
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: ApoB/Apo A1 ratio
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: waist-hip-ratio
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: waist circumference
timeFrame: 14-18 months postpartum
measure: Clinical cardiovascular follow-up at recruitment hospital: serum biomarkers associated to cardiovascular risk
timeFrame: 14-18 months postpartum
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anne Cathrine Staff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: