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Not yet recruiting NCT07691541

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

No phase Interventional Maternal Health Care Hypertensive Disorder of Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Connected MOM +.
Who it may be relevant to
Registry conditions: Maternal Health Care, Hypertensive Disorder of Pregnancy. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

Study outcomes include: 1) To determine whether providing enhanced support and coaching to support Connected MOM use increases use among those who stand to benefit; 2) To determine whether Connected MOM and healthcare resources are more appropriately used with provision of additional support; and 3) To determine whether the enhancement of support for the Connected MOM program improves maternal and infant health outcomes.

Interventions

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

Primary outcome measures

  • Successful use of the intervention and control programs measured by enrollment aggregate [Time frame: 6-9 months]
  • Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements [Time frame: 6-9 months]
  • Successful use of the intervention and control programs as determined by postpartum blood pressure measurement [Time frame: 6-9 months]
  • Adequacy of prenatal care [Time frame: 6-9 months]
  • Adverse composite maternal outcome [Time frame: 6-9 months]
Secondary outcome measures (5)
  • Reach [Time frame: 6-9 months]
  • Sustainability [Time frame: 6-9 months]
  • Engagement [Time frame: 6-9 months]
  • Retention [Time frame: 6-9 months]
  • Attendance of a postpartum visit [Time frame: 6-9 months]

Eligibility criteria

Inclusion criteria

  • 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
  • Reside in a zip code served by the participating clinics

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Ochsner Health — New Orleans

Identifiers

NCT: NCT07691541 · U54HD113159 (RP2) · U54HD113159

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗