The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.
Admitted to the neonatal intensive care unit (NICU)
Not readmitted after discharge from the NICU
Expected to survive at least 2 weeks
Expected to be admitted to the NICU for at least 2 weeks
Infant
Mother
No access to an Android or iOS smartphone
Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
Parallel
VoiceLove mobile phone application
DeviceAccess to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.
Patient Engagement with the VoiceLove App
To assess the feasibility of using the VoiceLove app, we will measure how much patients in the intervention group engage with the app using metrics such as average app use per day at 2-weeks post randomization.
Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization.
The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
EPDS Score at 6-weeks post randomization
The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks.
Edinburgh Postnatal Depression Score (EPDS) ≥ 13. The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
PROMIS Informational Support at 2- and 6-weeks post randomization
Patient-Reported Outcomes Measurement Information System (PROMIS). According to HealthMeasures, the following describes the PROMIS Informational Support: "Quality of social support refers to functional aspects of supportive relationships, i.e., interpersonal relationships that serve particular functions. This includes the interactive process by which emotional, instrumental or informational support is obtained from one's social network. It also includes companionship, feeling cared for and valued as a person, communication with others, and feelings of belonging and trust. Measures of social support generally seek information about a person's perception of the availability or adequacy of resources provided by others. The bank assesses perceived availability of helpful information or advice. The item bank does not use a time frame (e.g. over the past seven days) when assessing informational support. Informational Support instruments are available for adults (ages 18+)."
PROMIS Self-Efficacy at 2- and 6-weeks post randomization
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy is described as the following according to HealthMeasures: "an individual's confidence in his/her ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The PROMIS adult Self-Efficacy item banks assess self-reported current level of confidence in managing chronic conditions, including confidence in managing daily activities, managing emotions, managing medications and treatments, managing social interactions and managing symptoms. The self-efficacy item banks are universal rather than disease-specific. The respondent should be an adult (age 18+) and have at least one chronic health condition."
Clinically meaningful infant outcomes
Intraventricular hemorrhage (IVH), patent ductus arteriosus (PDA), sepsis, necrotizing enterocolitis (NEC), chronic lung disease (CLD)
Infant short-term outcomes
hearing test results
Infant short-term outcomes
length of stay
NICU Discharge Survey Results
Results of the NICU Discharge Survey that were submitted by maternal participants. The survey contains questions about mode of infant feeding, and scaled and open-ended questions about their perception of communication and engagement with their health care team.
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Vanderbilt University Medical Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
