Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT06741735
Status
Recruiting
Apply to this trial

Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INVU fetal monitoring system — DEVICE
    INVU fetal monitoring system allows for at-home non-stress testing as opposed to the typical in-clinic testing

Study Details

The goal of this clinical trial is to evaluate the potential benefit to patients and providers from using the remote fetal-monitoring system NUVO along with its app to allow for pregnant patients requiring weekly non-stress testing to do so from their homes. The main questions the investigators are looking to answer are: What effect does the NUVO remote fetal monitoring system have on patient/provider satisfaction? What is the cost savings (both direct and indirect) from using a remote fetal monitoring system as opposed to in-person testing for both the patient and the provider? Researchers will compare the survey responses by both patients and providers for pre and post implementation of the NUVO fetal monitoring system to the survey responses of patients and providers who used the traditional in-clinic method to evaluate satisfaction and cost savings. Participants will: Answer pre-implementation surveys before undergoing the trial Be randomly assigned to do either fetal testing at-home or in-clinic once or twice weekly as up to the provider Before hospital discharge or within the last office visit participants will be given a post-implementation survey

Key Dates

Start date
Dec 19, 2024
Status verified
Mar 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: At-home fetal monitoring
    Participants in this arm will be prescribed an INVU at-home fetal monitoring system. All training on the device use, troubleshooting, and accessing the cloud platform for telehealth (fetal) visits will be done by INVU through the INVU app. Non-stress testing will be done from home once or twice weekly as determined by provider at scheduled date and times.
  • No Intervention: In-office fetal monitoring
    In this arm, typical standard of care in-office fetal monitoring visits will be done. Participants will have non-stress testing done in clinic once or twice weekly as determined by provider at scheduled date and times.

Primary Outcome Measure

Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest framework [ Time Frame: Participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of MissouriColumbiaMissouri65212
Karen Florio, DO MPH
[email protected]
573-817-3386
Colin Paris, BS
[email protected]
573-817-3386
Karen Florio, DO MPH (PRINCIPAL_INVESTIGATOR)
University of Missouri - Kansas CityKansas CityMissouri64111
Traci Johnson, MD
[email protected]
(816) 287-9902
Anahi Primgaard
[email protected]
Affinia HealthcareSt LouisMissouri63104
Melissa Tepe, MD MPH
[email protected]
(314) 814-8700

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University of Missouri· Columbia, MOUniversity of Missouri - Kansas City· Kansas City, MOAffinia Healthcare· St Louis, MO

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