Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835596
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-21
First Post:
2023-03-08
Brief Title:
MumCare Mums Cardiovascular Health for Life
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
MumCare Mums Cardiovascular Health for Life
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MumCare
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 practitioners 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
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 practitioners 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None