Gestational Diabetes, Gestational Hypertension, Hypertensive Disorder of Pregnancy, Preeclampsia
Conditions
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 (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.
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 objective risk factors for CVD (evaluated 14-18 months postpartum in all study groups, including assessment of CV risk factors, CV function and biomarkers).
Interventions
DEVICEAccess to MumCare app
Education, push warning to book cardiovascular health follow-up at own general practitioner, registration of BP, blood sugars and lipids
Sponsors
Oslo University Hospital
Norwegian SIDS and Stillbirth Society
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Women are ranomized to MumCare app access or not for the 14-18 month intervention time
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Practitioner attendance 1 year postpartum | 1 year postpartum | Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measures (PROM); heiQ | 12-14 months postpartum | Patient reported (by online questionnaires) health-related quality of life: health education impact questionnaire. The Health Education Impact Questionnaire (heiQ) scale consists of 40 items representing 8 domains that evaluates immediate effects of self-management interventions. Items are scored on a scale ranging from 1 (strongly disagree) to 4 (strongly agree), higher score in the heiQ scales indicates better status, except for "emotional distress", where higher score indicates higher distress. |
| Patient Reported Outcome Measures (PROM); GSE | 12-14 months postpartum | Patient reported (by online questionnaires) health-related quality of life: general self-efficacy scale. The General Self Efficacy (GSE) Scale measures optimistic self-beliefs in coping with the challenges of life. : "refers to optimistic self-beliefs of being able to perform and control behaviors, and is linked with various physical and mental health outcomes". Responses on 10 items are reported on a four point scale ranging from 1 (not at all true) to 4 (exactly true). The score of the total scale ranges from 10 to 40, higher score indicates higher GSE. |
| Patient Reported Outcome Measures (PROM); IPAQ | 12-14 months postpartum | Patient reported (by online questionnaires) physical activity The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. The "last 7 days recall" short form of IPAQ is used in the MumCare study to assess level of physical activity. The short version (9 items) asks for information on the time spent walking, in vigorous- and moderate-intensity activity and in sedentary activity. Participants are instructed to refer to all domains of physical activity. |
| System usability scale (SUS) questionnaire | 12-14 months postpartum | Patient reported (for the group randomized to MumCare app access) (by online questionnaire) usability of the Mumcare health app, by the most frequently used questionnaire today to assess eHealth applications (SUS). |
| Qualitative interviews of users and their General Practiotioner | 14-18 montths postpartum | Compare user experiences (health perception, empowerment, quality of life) with and without app use (for both woman and her GP) |
| Clinical cardiovascular follow-up at recruitment hospital: Blood pressure | 14-18 months postpartum | Normotension (or not) at 14-18 months postpartum (blood pressure below 140 mmHg systolic AND below 90 mmHg diastolic) |
| Clinical cardiovascular follow-up at recruitment hospital: BMI | 14-18 months postpartum | Normal weight (or not) at 14-18 months postpartum; defined as body mass index (weight in kilo s divided by height in square meters) below 25 kg/m2 |
| Clinical cardiovascular follow-up at recruitment hospital: HbA1c | 14-18 months postpartum | Normal HbA1(or not) at 14-18 months postpartum; defined as below 42 mmol/L. Diabetes mellitus is diagnosed if HbA1c is 48 mmol/L or above, whereas HbA1c of 42-47 mmol/L indicates high risk for developing diabetes (and life style intervention combined with annual HbA1c assessment is therefore recommended) |
| Clinical cardiovascular follow-up at recruitment hospital: HDL | 14-18 months postpartum | Normal (or not) level of high density lipoprotein at 14-18 months postpartum; defined as HDL of 1.3 mmol/L or above (for women). HDL below 1.3 mmol/L indicates high risk for developing cardiovascular disease. |
| Clinical cardiovascular follow-up at recruitment hospital: Total cholesterol | 14-18 months postpartum | Normal (or not) level of total serum cholesterol at 14-18 months postpartum; defined as serum cholesterol at or below 5 mmol/L. Total cholesterol above 5 mmol/L indicates increased risk for developing cardiovascular disease. Total cholesterol of or above 7 mmol/L indicates most often therapy. |
| Clinical cardiovascular follow-up at recruitment hospital: LDL cholesterol | 14-18 months postpartum | Normal (or not) level of LDL (low density lipoprotein) cholesterol at 14-18 months postpartum; defined as LDL cholesterol at or below 3 mmol/L. LDL cholesterol above 3 mmol/L indicates increased risk for developing cardiovascular disease. LDL cholesterol of or above 5 mmol/L indicates most often therapy. |
| Clinical cardiovascular follow-up at recruitment hospital: fTG | 14-18 months postpartum | Normal (or not) level of fasting serum triglycerides at 14-18 months postpartum; defined as fTG at or below 1.7 mmol/L. fTG above 1.7 mmol/L combined with HDL cholesterol below 1.2 mmol/L in women indicates dyslipidemia and increased risk for developing cardiovascular disease. |
| Clinical cardiovascular follow-up at recruitment hospital: ApoB | 14-18 months postpartum | Normal (or not) serum Apolipoptotein B at 14-18 months postpartum; defined as ApoB above 1.4 g/L. The normal reference range for women is 0.5-1.4 g/L. High levels indicate increased risk for developing cardiovascular disease. |
| Clinical cardiovascular follow-up at recruitment hospital: Apo A1 | 14-18 months postpartum | Normal (or not) serum Apolipoptotein A1 at 14-18 months postpartum; defined as Apo A1 within the normal reference range for women: 1.1-2.0 g/L. |
| Clinical cardiovascular follow-up at recruitment hospital: ApoB/Apo A1 ratio | 14-18 months postpartum | Normal (or not) serum Apolipoptotein B/Apolipoprotein A1 ratio at 14-18 months postpartum; defined as ApoB/Apo A1 ratio at or below 0.6. In women, a ratio above 0.6 indicates increased risk of cardiovascular disease. |
| Clinical cardiovascular follow-up at recruitment hospital: waist-hip-ratio | 14-18 months postpartum | Normal (or not) waist to hip ratio (both measured in same unit; in nearest full cm) at 14-18 months postpartum; defined as a ratio below 0.85 in women. |
| Clinical cardiovascular follow-up at recruitment hospital: waist circumference | 14-18 months postpartum | Normal (or not) waist circumference (measured in nearest full cm) at 14-18 months postpartum; defined as a below 88 cm in women. |
| Clinical cardiovascular follow-up at recruitment hospital: serum biomarkers associated to cardiovascular risk | 14-18 months postpartum | Compare serum cardiovascular biomarker levels (between the 2 study groups) at a general cardiovascular health assessment at 14-18 months postpartum. Following (elevated levels) biomarkers have been associated with increased cardiovascular risk, and will be assessed for group comparison following study finalization: hsCRP, high-sensitive C-reactive protein GDF-15, growth differentiation factor 15 sHLA-G, soluble human leukocyte antigen G cTnT, cardiac-specific high sensitive Troponin T NT-proBNP, n-terminal pro-brain natriuretic peptide SAA1, serum amyloid 1 |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORAnne Cathrine Staff, MD, PhD
Oslo University Hospital
Outcome results
None listed