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

NCT ID: NCT02914301

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-05-31

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.

Detailed Description

This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on:

1. the number of in-person OB visits during pregnancy;

2. patient satisfaction with prenatal care;

3. gestational weight gain;

4. maternal and fetal outcomes; and

5. clinician satisfaction.

To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.

Conditions

Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Babyscripts Prenatal App

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.

Group Type: ACTIVE_COMPARATOR

Babyscripts Prenatal App

Intervention Type: DEVICE

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

No Mobile App, Usual care

Interventions

Babyscripts Prenatal App

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

Intervention Type: DEVICE

Placebo

No Mobile App, Usual care

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

1EQ, Inc.

INDUSTRY

Sponsor Role: collaborator

Andrew Meltzer

OTHER

Sponsor Role: lead

Responsible Party

Andrew Meltzer

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew C Meltzer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Locations

George Washington University Hospital

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31042154 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

https://getbabyscripts.com/

site for mobile app

Other Identifiers

BABYSCRIPTS 1B

Identifier Type: -

Identifier Source: org_study_id