Clinical trial NCT05853666: Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU
Official title: Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU Using an eHealth Solution (The CONNECT Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Self Efficacy
Infant Development
eHealth
Mental Health Wellness 1
Keywords: Neonatal
Parents
Families
eHealth
Implementation
Parent mental health
Infant outcomes
Parent presence
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-05-11
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The CONNECT study is an unblinded multicentre stepped wedge cluster randomized controlled trial guided by a Hybrid-1 design examining the effectiveness and implementation of CNH+ compared to usual care (control) across four Canadian NICUs. All sites will begin in the control period (baseline). Every 5 months, one site will be randomized to CNH+ using a stepped wedge design allowing for 4 sites with 5 measurement steps.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 800 parents and their babies, who are expected to stay at least 5 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.


Eligibility criteria: Inclusion Criteria:

* Parents who have an infant admitted to the NICU
* Parents who provide consent to participate within 7 days following birth
* Infant (regardless of gestational age or diagnosis) is anticipated to have at least a 5-day NICU stay

Exclusion Criteria:

* Parents who are unable to read or write English
* Parents whose infant is not anticipated to survive within the 7-day enrollment period after birth based on attending physician assessment

Primary outcomes:
measure: Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)
measure: Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 21 days (after the infant is born)
timeFrame: At baseline and 21 days after the infant is born
measure: Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 6 months (after the infant is discharged from the NICU)
timeFrame: At baseline and 6 months after the infant is discharged from the NICU
Secondary outcomes:
measure: Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
measure: Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at 21 days (after the infant is born)
timeFrame: At baseline and at 21 days (after the infant is born)
measure: Change from baseline parental level of NICU-specific stressors (as measured using the Parental Stressor Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
measure: Change from baseline parental level of NICU-specific stressors (as measured using the Parental Stressor Scale tool) at 21 days (after the infant is born)
timeFrame: At baseline and at 21 days (after the infant is born)
measure: Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
measure: Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 14 days (after the infant is born)
timeFrame: At baseline and at 14 days (after the infant is born)
measure: Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 21 days (after the infant is born)
timeFrame: At baseline and at 21 days (after the infant is born)
measure: Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)
measure: Change from baseline parental quality of life (as measured using the Quality of Life (EQ-5D-5L) tool) at 21 days (after the infant is born)
timeFrame: At baseline and at 21 days (after the infant is born)
measure: Perceived amount of family-centred care in the NICU (as measured using the Family Centred Care Scale tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Perceived amount of family engagement in care in the NICU (as measured using the CO-PARTNER Tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Perceived parental readiness to have their infant discharged from the NICU and sent home (as measured using the Readiness for Hospital Discharge tool) at infant discharge date (immediately after the infant is discharged from the NICU)
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Infant weight growth (change in weight since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Infant head growth (change in head circumference since birth) at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Infant length of stay in the NICU (in days) at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU, totalled at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Infant receipt of breast milk at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Amount of time for the infant to reach full enteral feeds during their stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of mortality during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of necrotizing enterocolitis (Stage >II) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of late-onset sepsis during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of chronic lung disease during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of retinopathy of prematurity (Stage ≥3) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of severe brain injury during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of treated Patent Ductus Arteriosus (PDA) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Incidence of air leak during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Duration of respiratory support (invasive and non-invasive) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Duration of oxygen supplementation during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Duration of total parenteral nutrition (TPN) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Duration of hypoxic ischemic encephalopathy (HIE) during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Number of infant's days with a central venous line in situ during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Number of infant central line-associated bloodstream infections during the infant's stay in the NICU, recorded at infant discharge date (immediately after the infant is discharged from the NICU).
timeFrame: At infant discharge date (immediately after the infant is discharged from the NICU)
measure: Infant neurological examination score at 18 months corrected gestational age
timeFrame: At 18 months of the infants corrected gestational age
measure: Infant hearing assessment score at 18 months corrected gestational age
timeFrame: At 18 months of the infants corrected gestational age
measure: Infant vision assessment score at 18 months corrected gestational age
timeFrame: At 18 months of the infants corrected gestational age
measure: Infant development score at 18 months corrected gestational age
timeFrame: At 18 months of the infants corrected gestational age
measure: Number of Chez NICU Home educational modules completed at 6 months after the discharge of the infant from the NICU.
timeFrame: At 6 months after the discharge of the infant from the NICU
measure: Number of Chez NICU Home educational modules viewed at 6 months after the discharge of the infant from the NICU.
timeFrame: At 6 months after the discharge of the infant from the NICU
measure: Amount of time spent on the Chez NICU Home platform at 6 months after the discharge of the infant from the NICU.
timeFrame: At 6 months after the discharge of the infant from the NICU
measure: Number of text messages received by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
timeFrame: At 6 months after the discharge of the infant from the NICU
measure: Number of virtual communication tools used by parents of infants in the NICU, completed at 6 months after the discharge of the infant from the NICU.
timeFrame: At 6 months after the discharge of the infant from the NICU
measure: Number of parents of infants in the NICU who enroll in CNH+ when offered?
timeFrame: At baseline (upon enrollment to the study)
measure: Parents' perceived ease of use of the CNH+ intervention (as measured using the e-Health impact questionnaire) at 6 months after the discharge of the infant from the NICU)
timeFrame: At 6 months after the discharge of the infant from the NICU
Other outcomes:
Locations:
Study officials:
affiliation: Dalhousie University
name: Marsha Campbell-Yeo, RN NNP PhD
role: PRINCIPAL_INVESTIGATOR
References: