- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02379351
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase I of this study enrolls pregnant women with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at the University of Utah Hospital. Participants receive an in-clinic NST with the Airstrip® Sense4Baby™ device, are taught how to use the device, and asked to demonstrate their ability to use the device. Once the participant successfully demonstrates use of the monitor the device is given to the participant to use at the scheduled time each week. Patients receive educational materials, including a visuals-enhanced, short quick start guide.
For her remote NST monitoring, the patient will receive a virtual NST appointment. At the time of the scheduled appointment, the patient will apply the monitor and the NST will be read by the mid-level provider staffing the testing center after a thirty-minute strip has been recorded and transmitted to the database. The NST will also be interpreted by the maternal-fetal medicine physician, according to the established workflow. The patient will be notified of the result by a telephone call from the mid-level provider and appropriate follow-up arranged according to the NST management algorithm developed for this study. If the patient has trouble with using the device at home, the patient will be able to talk with the mid-level provider via telephone to troubleshoot issues.
The patient will also continue to receive an NST in clinic weekly. These NST schedules will be repeated on a weekly basis until delivery or until the provider discontinues the NST order.
Patients will be contacted after delivery to assess overall satisfaction with the NST at home versus in clinic.
Phase II of this study will enroll the same patient population (pregnant women with physician-ordered twice-weekly NSTs scheduled). Participants in Phase II may receive NSTs up to twice weekly at home. During regularly scheduled obstetric visits (every 1 to 2 weeks depending on gestational age and circumstances), NSTs will be performed on site. However, we will remove the requirement for once weekly on-site testing at the University of Utah Hospital.
The requirement to be within a 60-mile radius of University Hospital will be removed for Phase II participants. Instead, the requirement will be to be within a 60-mile radius of a hospital with an obstetric unit.
Patients will be contacted after delivery to assess overall satisfaction with the NST at home versus in clinic.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84132
- University Of Utah
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Target population: The target population is high-risk pregnant women.
Accessible population: The accessible population is high-risk obstetric patients receiving care throughout the University of Utah Healthcare system and who receive their NSTs at MFDC.
Inclusion Criteria (Phase I):
- Singleton gestation
- Estimated gestational age of 32 0/7 -37 6/7 weeks
- Physician order for twice weekly NSTs
- Live within 60-mile radius of the University of Utah University Hospital
- Reliable access to and connectivity with wireless Internet
- Reliable for communication and follow-up
Exclusion Criteria (Phase I:
- Multifetal gestation
- Maternal age less than 18
- Plans to move prior to end of pregnancy
- No or limited access to internet and/or phone
Inclusion Criteria (Phase II):
- Singleton gestation
- Estimated gestational age of 32 0/7 -37 6/7 weeks
- Physician order for twice weekly NSTs
- Live within 60-mile radius of the University of Utah University Hospital or a hospital with an obstetric inpatient unit
- Reliable access to and connectivity with wireless Internet
- Reliable for communication and follow-up
Exclusion Criteria (Phase II):
- Multifetal gestation
- Maternal age less than 18
- Plans to move prior to end of pregnancy
- No or limited access to internet and/or phone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: In-Home Non-Stress Test Device
Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital will be eligible for enrollment.
After being taught how to use the Airstrip® Sense4Baby™ system machine, participants will use the device on a weekly basis (at home) until the time of delivery.
Participants will also receive an in clinic NST once a week.
|
Airstrip® Sense4Baby™
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Integration of Airstrip ® Sense4Baby™ remote non-stress test monitoring into health care system
Time Frame: 2 Years
|
Successful 'integration' will be defined by the ability to schedule remote non-stress tests, mid-level provider visualization and interpretation, communication of conclusion and recommendations to patients, physician visualization and interpretation, and clinical billing.
|
2 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of uninterpretable and/or abnormal NSTs requiring on-site follow-up
Time Frame: 2 Years
|
2 Years
|
Patient and provider satisfaction with remote NST compared to on-site NST (questionnaire)
Time Frame: 2 Years
|
2 Years
|
Cost-effectiveness analysis for the health system and for patients
Time Frame: 2 Years
|
2 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin AS Clark, M.D., University Of Utah
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 77591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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