Health TrialsbyHealthPanel

Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus

ConditionsMaternal Health CareHypertensive Disorder of Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorTulane University

About this trial

Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Access to a smartphone

Understanding of English or Spanish in oral and written discourses

Have a participating Ochsner-employed provider

Plan to deliver at a participating Ochsner hospital

Disqualifiers

Provider feels that study participation is not in patient's best interest

Does not understand English or Spanish well enough to follow recommendations

Plans to move from the study area served by the participating clinics

Trial design

Design model

Parallel

Treatments tested in this trial

  • Connected MOM +

    Other intervention

    Navigator support to encourage enrollment, consistent use, and postpartum follow-up in Connected MOM program

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Intervention - CM+Active comparator 1 intervention
Group B: Control - CMNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Successful use of the intervention and control programs measured by enrollment aggregate

Aggregate enrollment in the intervention or control arms by 25 weeks of gestation relative to the total number of eligible participants. This will be measured by the total number of women participating in the Connected MOM or Connected MOM+ divided by the total number of eligible pregnant women presenting to the hospital.

Time frame
6-9 months
2

Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements

This is determined by measuring the systolic and diastolic blood pressure in mmHg at least once per week during pregnancy.

Time frame
6-9 months
3

Successful use of the intervention and control programs as determined by postpartum blood pressure measurement

This is determined by measuring at least one postpartum blood pressure measurement (systolic and diastolic) in mmHg before a postpartum visit.

Time frame
6-9 months
4

Adequacy of prenatal care

Adequacy of prenatal care will be measured using the Kotelchuck index, a score that assesses the adequacy of maternal health care. The score ranges from 0% to above, with higher scores indicating better maternal health care.

Time frame
6-9 months

Secondary outcomes

1

Reach

Number of patients enrolled by 25 weeks' gestation)/# of patients either eligible, order placed, onboarded, or contacted by navigator

Time frame
6-9 months
2

Sustainability

Number of Connected MOM enrolled pregnancies in a given year / # eligible pregnancies by geographic residence

Time frame
6-9 months
3

Engagement

Percent of eligible weeks with a remote BP measurement

Time frame
6-9 months
4

Retention

Percent of people who remain in the program to delivery and to 4-6 weeks postpartum

Time frame
6-9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Ochsner Health System

Collaborator

Source ClinicalTrials.gov
Apply now