Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study

NCT02914301 | Completed Results

• 1 other identifier: BABYSCRIPTS 1B
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Total Visit Number

  In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.

  From first trimester up to postpartum, between 6 and 9 months

Secondary Outcomes (1)

• Gestational Weight Gain

  From first trimester up to postpartum, between 6 and 9 months

Study Arms (2)

Babyscripts Prenatal App

ACTIVE COMPARATOR

For patients allocated to the experimental group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients allocated to this study arm, the clinician will be informed and therefore, will be receiving regular app-based education while the clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care.

Device: Babyscripts Prenatal App

Placebo

PLACEBO COMPARATOR

For patients cared for by clinicians allocated to the control (usual care) arm, the clinician will discuss the management options and scheduling procedures with the patient in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians.

Device: Placebo

Interventions

Babyscripts Prenatal App DEVICE

The use of a mobile digital app to facilitate certain aspects of standard prenatal care.

Babyscripts Prenatal App

Placebo DEVICE

No Mobile App, Usual care

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible participants will be women who are between 18 than 40-years-old, who are visiting the OB for a first-trimester verification of pregnancy visit, new OB visit or follow-up OB visit, who are low-risk per treating OB, who regularly use a smart-phone, who can understand and consent to English-written consent form.
• Eligible clinicians will be attending obstetric physicians who refer the patient to the research assistant for informed consent and full eligibility assessment.

You may not qualify if:

• High-risk obstetrical condition\*
• Intends midwifery care
• Intends to terminate
• Not Local resident
• Non--English speaker

Sponsors & Collaborators

• Andrew Meltzer: lead
• 1EQ, Inc.: collaborator

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, Oh J, Richards LM, Meltzer AC. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019 May 1;7(5):e10520. doi: 10.2196/10520.

  PMID: 31042154 DERIVED

Related Links

• site for mobile app

Results Point of Contact

• Title: Dr. Andrew C. Meltzer
• Organization: George Washington University School of Medicine & Health Sciences- Department of Emergency Medicine

ameltzer@mfa.gwu.edu

202-741-2952

Study Officials

• Andrew C Meltzer, MD, MS

  The George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 26, 2016
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 16, 2022
• Results First Posted: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)