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MumCare: Mum's Cardiovascular Health for Life (MumCare)

Primary Purpose

Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Access to MumCare app
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertensive Disorder of Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Access to MumCare app

No access to MumCare app

Arm Description

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 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).

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.

Outcomes

Primary Outcome Measures

General Practitioner attendance 1 year postpartum
Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients)

Secondary Outcome Measures

Patient Reported Outcome Measures (PROM); SF-36
Patient reported (by online questionnaires) health-related quality of life (short-form-health survey 36). The Short-Form Health Survey 36 (SF36) scale consists of 36 items related to health perception, grouped into eight multi-item scales ranging from 0 to 100 (0=worst, 100=best). Differences in SF-36 subscale scores of 5 points have been considered clinically relevant.
Patient Reported Outcome Measures (PROM); heiQ
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
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); SOC-13
Patient reported (by online questionnaires) health-related quality of life: sense of coherence. The Sense of Coherence (SOC-13) scale consists of 13 items measuring the perception of manageability, meaningfulness and comprehensibility. The scale of the items ranges from 1 to 7, while the total sum ranges from 13 to 91, where higher score indicates a higher sense of coherence.
Patient Reported Outcome Measures (PROM); EPDS
Patient reported (by online questionnaires) health-related quality of life: Edinburgh Postnatal Depression Scale. The Edinburgh Postnatal Depression Scale (EPDS) scale consists of 10 items evaluating depression on a total score from 0 to 30. A score of ≥10 indicates depression.
Qualitative interviews of users and their General Practiotioner
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
March 8, 2023
Last Updated
April 18, 2023
Sponsor
Oslo University Hospital
Collaborators
Norwegian SIDS and Stillbirth Society, University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT05835596
Brief Title
MumCare: Mum's Cardiovascular Health for Life
Acronym
MumCare
Official Title
MumCare: Mum's Cardiovascular Health for Life
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2029 (Anticipated)
Study Completion Date
September 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian SIDS and Stillbirth Society, University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension, Gestational Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Women are ranomized to MumCare app access or not for the 18 month intervention time
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Access to MumCare app
Arm Type
Active Comparator
Arm Description
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 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).
Arm Title
No access to MumCare app
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Access to MumCare app
Intervention Description
Education, push warning to book cardiovascular health follow-up at own general practitioner , registration of BP and lipids, HbAc
Primary Outcome Measure Information:
Title
General Practitioner attendance 1 year postpartum
Description
Cardiovascular risk screening at general practitioner attendance (guideline recommeded, but rarely followed-up by patients)
Time Frame
1 year postpartum
Secondary Outcome Measure Information:
Title
Patient Reported Outcome Measures (PROM); SF-36
Description
Patient reported (by online questionnaires) health-related quality of life (short-form-health survey 36). The Short-Form Health Survey 36 (SF36) scale consists of 36 items related to health perception, grouped into eight multi-item scales ranging from 0 to 100 (0=worst, 100=best). Differences in SF-36 subscale scores of 5 points have been considered clinically relevant.
Time Frame
13-14 months postpartum
Title
Patient Reported Outcome Measures (PROM); heiQ
Description
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.
Time Frame
13-14 months postpartum
Title
Patient Reported Outcome Measures (PROM); GSE
Description
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.
Time Frame
13-14 months postpartum
Title
Patient Reported Outcome Measures (PROM); SOC-13
Description
Patient reported (by online questionnaires) health-related quality of life: sense of coherence. The Sense of Coherence (SOC-13) scale consists of 13 items measuring the perception of manageability, meaningfulness and comprehensibility. The scale of the items ranges from 1 to 7, while the total sum ranges from 13 to 91, where higher score indicates a higher sense of coherence.
Time Frame
13-14 months postpartum
Title
Patient Reported Outcome Measures (PROM); EPDS
Description
Patient reported (by online questionnaires) health-related quality of life: Edinburgh Postnatal Depression Scale. The Edinburgh Postnatal Depression Scale (EPDS) scale consists of 10 items evaluating depression on a total score from 0 to 30. A score of ≥10 indicates depression.
Time Frame
13-14 months postpartum
Title
Qualitative interviews of users and their General Practiotioner
Description
Compare user experiences (health perception, empowerment, quality of life) with and without app use (for both woman and her GP)
Time Frame
13-14 montths postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: Blood pressure
Description
Normotension (or not) at 14-18 months postpartum (blood pressure below 140 mmHg systolic AND below 90 mmHg diastolic)
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: BMI
Description
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
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: HbA1c
Description
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)
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: HDL
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: Total cholesterol
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: LDL cholesterol
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: fTG
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: ApoB
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: Apo A1
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: ApoB/Apo A1 ratio
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: waist-hip-ratio
Description
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.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: waist circumference
Description
Normal (or not) waist circumference (measured in nearest full cm) at 14-18 months postpartum; defined as a below 88 cm in women.
Time Frame
14-18 months postpartum
Title
Clinical cardiovascular follow-up at recruitment hospital: serum biomarkers associated to cardiovascular risk
Description
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
Time Frame
14-18 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Cathrine Staff, MD, PhD
Phone
0047 41303081
Email
uxnnaf@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Meryam Sugulle, MD, PhD
Phone
0047 41688655
Email
uxsume@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Cathrine Staff, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Cathrine Staff, MD, PhD
Phone
0047 41303081
Email
uxnnaf@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Meryam Sugulle, MD, PhD
Phone
0047 41688655
Email
uxsume@ous-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only data that alone or in combination cannot identify a unque patient will be shared, that is at group level, in accordance with patient consent and IRB approval in Norway.

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MumCare: Mum's Cardiovascular Health for Life

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