Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

Completed

• Conditions: Pregnancy Related; Preterm Birth
• Interventions: Behavioral: MyHealthyPregnancy

• Registration Number: NCT05502510
• Lead Sponsor: Naima Health LLC

Brief Summary

One in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. Solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. This study will evaluate MyHealthyPregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.

Detailed Description

MyHealthyPregnancy (MHP) is an application that was developed using behavioral decision science principles. This study seeks to evaluate the effectiveness and efficacy of the application. MyHealthyPregnancy was offered to expectant mothers at the University of Pittsburgh Medical Center in conjunction with usual prenatal care. The primary objective is to compare the reduction in gestational age at birth between MHP and usual care cohorts. Secondary objectives include comparing births occurring prior to 37 weeks of gestation, depression rates, anxiety rates, referrals to behavioral health, referrals to social workers, preeclampsia rates, gestational weight gain, number of prenatal appointments attended, and percent of required prenatal appointments attended between the MHP and usual care cohorts.

Study Timeline

• Study Start: 2019-09-23
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-08
• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12344

Inclusion Criteria

• Offered a prescription for MyHealthyPregnancy
• 18+ years of age
• Pregnant
• Seeking care at a UPMC hospital
• Delivered at a UPMC hospital

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MyHealthyPregnancy (MHP)	MyHealthyPregnancy	Use of the MyHealthyPregnancy application in conjunction with usual care.

Primary Outcome Measures

Name	Time	Method
Gestational Age at Birth	Baseline to 40 Weeks	Gestational age at birth will be measured using each patients electronic health record. The average treatment effect will be calculated using linear regression comparing MHP and usual care cohorts.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects gestational age at birth.

Secondary Outcome Measures

Name	Time	Method
Referrals to Behavioral Health Specialists	Baseline to 40 Weeks	Rates of referrals to behavioral health specialists will be measured using each patient's electronic health record. Rates in referrals between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects rates of referrals.
Attendance at Required Prenatal Appointments	Baseline to 40 Weeks	The percent of required prenatal appointments attended will be measured using each patient's electronic health record. The percent of visits attended between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects attendance at prenatal visits.
Prenatal Births	Baseline to 37 Weeks	Occurrence of preterm birth will be measured using each patient's electronic health record. The likelihood of preterm birth between the MHP and usual care cohorts will be compared using logistic regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects preterm birth.
Attendance at Prenatal Appointments	Baseline to 40 Weeks	Number of prenatal visits attended will be measured using each patient's electronic health record. The number of visits attended between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects attendance at prenatal visits.
Referrals to Social Workers	Baseline to 40 Weeks	Rates of referrals to social workers will be measured using each patient's electronic health record. Rates in referrals between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects rates of referrals.
Gestational Weight Gain	Baseline to 40 Weeks	Gestational weight gain will be measured by calculating the difference between each patient's initial weight and delivery weight recorded in their electronic health record. Gestational weight gain will be categorized as sufficient or insufficient according to 2009 Institute of Medicine guidelines. The likelihood of achieving sufficient gestational weight gain between the MHP and usual care cohorts will be compared using ordinal regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects the likelihood of achieving sufficient gestational weight gain.
Depression Rates	Baseline to 40 Weeks	Depression rates will be measured using diagnoses of depression in each patient's electronic health record. Depression rates between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects depression rates.
Anxiety Rates	Baseline to 40 Weeks	Anxiety rates will be measured using diagnoses of anxiety in each patient's electronic health record. Anxiety rates between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects anxiety rates.
Preeclampsia	Baseline to 40 Weeks	Preeclampsia will be measured using each patient's electronic health record. Rates of preeclampsia between the MHP and usual care cohorts will be compared using linear regression.; Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects preeclampsia.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States