Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

Pregnancy Related Clinical Trial

Official title:

Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502510
• Other study ID #: 1684
• Status: Completed
• Start date: September 23, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2022
• Source: Naima Health LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12344
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Pregnancy Related
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• MyHealthyPregnancy
MyHealthyPregnancy is a mobile application prescribed to expectant mothers in conjunction with normal prenatal care. The application uses behavioral decision science principles to identify risks of preterm birth and alert the mother and care team of these risks.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Naima Health LLC	Carnegie Mellon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Age at Birth	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.	Baseline to 40 Weeks
Secondary	Prenatal Births	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.	Baseline to 37 Weeks
Secondary	Depression Rates	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.	Baseline to 40 Weeks
Secondary	Anxiety Rates	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.	Baseline to 40 Weeks
Secondary	Referrals to Behavioral Health Specialists	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.	Baseline to 40 Weeks
Secondary	Referrals to Social Workers	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.	Baseline to 40 Weeks
Secondary	Preeclampsia	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.	Baseline to 40 Weeks
Secondary	Gestational Weight Gain	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.	Baseline to 40 Weeks
Secondary	Attendance at Prenatal Appointments	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.	Baseline to 40 Weeks
Secondary	Attendance at Required Prenatal Appointments	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.	Baseline to 40 Weeks