NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Patient Engagement with the VoiceLove App
研究概览
简要总结
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.
详细描述
This study is a randomized control trial that will test VoiceLove, a secure mobile app designed to help families communicate with their infants in the Neonatal Intensive Care Unit (NICU).
Postpartum depression (PPD) is a major depressive disorder and is one of the most frequent childbirth complications. Mother-infant separation during the initial postpartum period, such as infant admission to the neonatal intensive care unit (NICU), impacts mother-infant bonding and increases PPD risk, which is 40% higher in mothers with children admitted to the NICU. The impact of PPD is substantial: reported poor quality of life, high-risk behaviors such as substance abuse or self-harm, and long-term impairments in child cognitive and emotional development. PPD impact on child development has potential to be magnified in the already vulnerable preterm infant population. Care in the NICU is, by design, focused on the health of the infant and ill-equipped to address parental mental health. High stress and burnout among NICU staff combined with limited resources for development of psychosocial programs targeting the parents of NICU patients underscore the need for simple, low-cost, and easily implemented interventions aimed at improving parental connectedness and reducing postpartum mental health disorders.
Lack of parental connectedness to their neonate during a NICU stay and low social support are two of the most powerful risk factors for developing PPD. Risk of PPD is decreased when parents have more contact, either physical or verbal, with their infant and a higher perceived social support system. When physical contact is not possible, voice contact may help foster feelings of connectedness to both the infant in the NICU, and to the parents' social circle. The medical team is another critical source of support poised to increase parental mental health. Mothers of infants in the NICU report increased depressive symptoms when their perception of nurse support is low, while increased communication between parents and the medical team improves parental well-being. Increased social support from loved ones and the medical care team is well positioned to significantly reduce PPD severity in parents of NICU infants. Thus, facilitation of communication between parents and healthcare providers, as well as between their friends and family, presents a low-cost, low effort means to dramatically impact parental mental health and well-being during a NICU admission.
VoiceLove Inc has developed a novel HIPAA-compliant mobile application that offers programmatic support and curated digital content (e.g., lullabies, music, environmental sounds) for infant-family interactions and enables expanded family engagement in hospital settings. VoiceLove mobile app circumvents barriers to communication through an electronic venue for direct patient-family-clinician interaction. Specifically for clinicians, VoiceLove is a safe and time-efficient tool for direct communication with absent family members, allowing more time for direct patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •Singleton gestation
- •Age ≥ 18 years old
- •English speaking
- •Mother is the biological mother of the infant admitted to the NICU
- •Postpartum day 4 or less
- •Partner (NOTE: Partner enrollment is not required)
- •Mother agrees to partner's participation
- •Designated by mother as support person with infant access
排除标准
- •a. Re-admission to NICU
- •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
- •No personal email address
- •Incarcerated at time of delivery or postpartum
- •Inability to obtain informed consent
- •i. Patient's clinician refuses enrollment of the patient ii. Patient is either mentally (acute psychosis) or physically (intubated or critically ill in the ICU) unable to provide informed consent f. Unable to approach the patient (staffing, patient unavailable) g. Mother is not the intended parent (plans adoption, is a surrogate, will not have custody of the infant)
- •Partner (NOTE: Partner enrollment is not required)
- •Age < 18 years old
- •Not English speaking
- •Inability to obtain informed consent
- •No access to an Android or iOS smartphone that is different from the mother's smartphone
- •No access to an email address that is different from the mother's email address
- •Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
研究组 & 干预措施
Intervention Arm
Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care and surveys.
干预措施: VoiceLove mobile phone application (Device)
Control Arm
Participants in this arm will be randomized to standard of care only and will not have access to the VoiceLove app. They will also complete surveys.
结局指标
主要结局
Patient Engagement with the VoiceLove App
时间窗: 2-weeks post randomization.
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.
时间窗: 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.
次要结局
- Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks.(2- and 6-weeks post randomization)
- PROMIS Informational Support at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- PROMIS Self-Efficacy at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- Generalized Anxiety Disorder 7-item (GAD 7) at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- Post Traumatic Stress Disorder Checklist (PCL-5) at NICU discharge(at infant's NICU discharge, up to six (6) months.)
- NICU length of stay(from NICU admission to NICU discharge, up to six (6) months.)
- Infant birth weight at NICU discharge(from NICU admission to NICU discharge, up to six (6) months.)
- App Usability and Satisfaction Scale at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- EPDS Score at 6-weeks post randomization(6-weeks post randomization.)
- Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks.(2- and 6-weeks post randomization)
- PROMIS Informational Support at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- PROMIS Self-Efficacy at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- Generalized Anxiety Disorder 7-item (GAD 7) at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
- Post Traumatic Stress Disorder Checklist (PCL-5) at NICU discharge(at infant's NICU discharge, up to six (6) months.)
- NICU length of stay(from NICU admission to NICU discharge, up to six (6) months.)
- Infant birth weight at NICU discharge(from NICU admission to NICU discharge, up to six (6) months.)
- App Usability and Satisfaction Scale at 2- and 6-weeks post randomization(2- and 6-weeks post randomization)
研究者
Sarah Osmundson
Associate Professor in Obstetrics and Gynecology
Vanderbilt University Medical Center