MumCare: Mum's Cardiovascular Health for Life
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- General Practitioner attendance 1 year postpartum
研究概览
简要总结
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 (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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
Access to MumCare app
Women will be randomized prospectively (before or after delivery) after they consent to participate in the study. These women are at increased risk of longterm cardiovascular disease due to hypertensive or gestational diabetes pregnancy complication. This group is randomized to have access to the MumCare app will, in addition to standard care, have access to the app for 14-18 months following giving birth. The MumCare app has 3 main parts (1. an educational part, 2. The patient's own health data (entered by the user herself) that represent modifiable risk factors for cardiovascular disease), and 3. The app will send push reminders for the woman to book a visit at her general practitioner according to recommended guidelines (that are usually not followed-up today).
All women in the study will be invited to a cardiovascular health evaluation at 14-18 months postpartum.
干预措施: Access to MumCare app (Device)
No access to MumCare app
Women will be prosepctively randomized (before or after delivery) after they consent to participate in the study. These women are at increased risk of longterm cardiovascular disease due to hypertensive or gestational diabetes pregnancy complication. Women randomized to NOT have access to the MumCare app will receive standard care, which includes being provided oral and written information according to delivery ward routines.
All women in the study will be invited to a cardiovascular health evaluation at 14-18 months postpartum.
结局指标
主要结局
General Practitioner attendance 1 year postpartum
时间窗: 1 year postpartum
Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients)
次要结局
- Clinical cardiovascular follow-up at recruitment hospital: Blood pressure(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: BMI(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: ApoB(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: HbA1c(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: LDL cholesterol(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: ApoB/Apo A1 ratio(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: waist-hip-ratio(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: HDL(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: Total cholesterol(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: Apo A1(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: waist circumference(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: serum biomarkers associated to cardiovascular risk(14-18 months postpartum)
- Clinical cardiovascular follow-up at recruitment hospital: fTG(14-18 months postpartum)
- Patient Reported Outcome Measures (PROM); heiQ(12-14 months postpartum)
- Patient Reported Outcome Measures (PROM); GSE(12-14 months postpartum)
- Patient Reported Outcome Measures (PROM); IPAQ(12-14 months postpartum)
- System usability scale (SUS) questionnaire(12-14 months postpartum)
- Qualitative interviews of users and their General Practiotioner(14-18 montths postpartum)
研究者
Anne Cathrine Staff
Professor and Head of research (Div. Obst and Gyn)
Oslo University Hospital