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NCT Number: NCT05853666

Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU

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 600 parents and their babies, who are expected to stay at least 14 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.

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Key information

Conditions

Self Efficacy Infant Development Mental Health Wellness 1 eHealth

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health

Halifax, Nova Scotia, B3K 6R8, Canada

Location status: Recruiting

Location contact

Amouchu Soraisham, MD

SUB_INVESTIGATOR

Cameron J Bruce, MSc

CONTACT

[email protected]

9024970898

Karel O'Brien, MD

SUB_INVESTIGATOR

Michael Narvey, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 14-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

Treatment and study plan

CNH+

Behavioral

CNH+ is a bundled intervention targeting all four of Bandura's factors associated with improved self-efficacy (i.e., Mastery [evidence-based parent targeted education platform]; Vicarious Experience [observing other families similar to them succeeding in a task i.e., videos and photos]; Verbal Persuasion [in-person/virtual medical rounds and provision of social support]; and Physiological States [notifications and encouragement through mHealth text messaging, parent feedback, and tailored clinical care pathway]).

Primary outcomes

  1. 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)

    Time frame: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy at their infant's discharge from the NICU? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).

  2. 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)

    Time frame: At baseline, discharge to another unit (if eligible), and 21 days after the infant is born

    In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment (baseline) and 21 days after the infant admitted to the NICU is born. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).

  3. 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)

    Time frame: At baseline and 6 months after the infant is discharged from the NICU

    In parents of NICU infants, does CNH+, when compared to standard care, change parental self-efficacy 6 months after the infant is discharged from the NICU? Measured using the Perceived Maternal Parenting Self-Efficacy (PMPS-E) tool at enrollment, and 6 months after the infant is discharged from the NICU. All primary parent/caregiver(s) (up to 3) will be asked to complete this measure. The PMPS-E has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of parental self-efficacy).

Secondary outcomes

  1. 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)

    Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level of stress at their infant's discharge from the NICU? Measured using the State Trait Anxiety Inventory (STAI) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The STAI has a minimum score of 20 and a maximum score of 80. A higher score indicates a worse outcome (higher levels of parental anxiety).

  2. Change from baseline parental level of stress (as measured using the State Trait Anxiety Inventory tool) at 21 days (after the infant is born)

    Time frame: At baseline and at 21 days (after the infant is born)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level of stress at 21 days after the infant is born? Measured using the State Trait Anxiety Inventory (STAI) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The STAI has a minimum score of 20 and a maximum score of 80. A higher score indicates a worse outcome (higher levels of parental anxiety).

  3. 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)

    Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level of NICU-specific stressors at their infant's discharge from the NICU? Measured using the Parental Stressor Scale (PSS NICU) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The PSS NICU has a minimum score of 18 and a maximum score of 90. A lower score indicates a better outcome (lower levels of parental NICU-specific stress).

  4. 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)

    Time frame: At baseline and at 21 days (after the infant is born)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level of NICU-specific stressors at 21 days after the infant is born? Measured using the Parental Stressor Scale (PSS NICU) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PSS NICU has a minimum score of 18 and a maximum score of 90. A lower score indicates a better outcome (lower levels of parental NICU-specific stress).

  5. 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)

    Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level of depression at their infant's discharge from the NICU? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).

  6. Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 14 days (after the infant is born)

    Time frame: At baseline and at 14 days (after the infant is born)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level depression at 14 days after the infant is born? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and at 14 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).

  7. Change from baseline parental level of depression (as measured using the Postpartum Depression Screening Scale tool) at 21 days (after the infant is born)

    Time frame: At baseline and at 21 days (after the infant is born)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental level depression at 21 days after the infant is born? Measured using the Postpartum Depression Screening Scale (PDSS) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The PDSS has a minimum score of 35 and a maximum score of 175. A higher score indicates a worse outcome (higher levels of postpartum depression).

  8. 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)

    Time frame: At baseline and at infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental quality of life at their infant's discharge from the NICU? Measured using the Quality of Life (EQ-5D-5L) tool at enrollment (baseline) and immediately after the discharge from the NICU of the infant admitted to the NICU, which marks the end of the in-hospital phase. The primary parent/caregiver(s) will be asked to complete this measure. The Quality of Life (EQ-5D-5L) has a descriptive score and a visual analog scale. The descriptive score has a minimum score of 5 and a maximum score of 25. A higher score indicates a worse outcome (lower levels of quality of life). The visual analog score has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of quality of life).

  9. 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)

    Time frame: At baseline and at 21 days (after the infant is born)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental quality of life at 21 days after the infant is born? Measured using the Quality of Life (EQ-5D-5L) tool at enrollment (baseline) and at 21 days after the infant admitted to the NICU is born. The primary parent/caregiver(s) will be asked to complete this measure. The Quality of Life (EQ-5D-5L) has a descriptive score and a visual analog scale. The descriptive score has a minimum score of 5 and a maximum score of 25. A higher score indicates a worse outcome (lower levels of quality of life). The visual analog score has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of quality of life).

  10. 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)

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental perceived amount of family-centred care in the NICU at their infant's discharge from the NICU? Measured using the Family Centred Care Scale tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The Family Centred Care Scale has a minimum score of 20 and a maximum score of 80. A higher score indicates a better outcome (higher levels of perceived amount of family-centred care in the NICU).

  11. 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)

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental perceived amount of family engagement in care in the NICU at their infant's discharge from the NICU? Measured using the CO-PARTNER Tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The CO-PARTNER Tool has a minimum score of 0 and a maximum score of 62. A higher score indicates a better outcome (higher levels of positive inherent relationship between participation and collaboration).

  12. 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)

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change parental perceived readiness to have their infant discharged from the NICU and sent home, at the time of their infant's discharge from the NICU? Measured using the Readiness for Hospital Discharge tool immediately after the discharge from the NICU of the infant admitted to the NICU. The primary parent/caregiver(s) will be asked to complete this measure. The Readiness for Hospital Discharge tool has a minimum average score of 0 and a maximum score of 10. A higher score indicates a better outcome (higher levels of readiness for hospital discharge).

  13. Infant weight growth (change in weight since birth) at infant discharge date (immediately after the infant is discharged from the NICU).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change infant weight growth (change in weight since birth) at the infant's discharge from the NICU? Data collected by chart review.

  14. Infant head growth (change in head circumference since birth) at infant discharge date (immediately after the infant is discharged from the NICU).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change infant head growth (change in head circumference since birth) at the infant's discharge from the NICU? Data collected by chart review.

  15. Infant length of stay in the NICU (in days) at infant discharge date (immediately after the infant is discharged from the NICU).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change infant length of stay in the NICU (in days) at the infant's discharge from the NICU? Data collected by chart review.

  16. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change the amount of provision of mothers' own breast milk for their infant during their infant's stay in the NICU? Data collected by chart review.

  17. Infant receipt of breast milk at infant discharge date (immediately after the infant is discharged from the NICU).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In parents of NICU infants, does CNH+, when compared to standard care, change the receipt of breast milk for their infant at the infant's discharge from the NICU? Data collected by chart review.

  18. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the amount of time for the infant to reach full enteral feeds during their stay in the NICU? Data collected by chart review.

  19. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of mortality during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  20. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of necrotizing enterocolitis (Stage >II) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  21. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of late-onset sepsis during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  22. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of chronic lung disease during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  23. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of retinopathy of prematurity (Stage ≥3) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  24. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of severe brain injury during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  25. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of treated Patent Ductus Arteriosus (PDA) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  26. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the incidence of air leak during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  27. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the duration of respiratory support (invasive and non-invasive) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  28. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the duration of oxygen supplementation during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  29. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the duration of total parenteral nutrition (TPN) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  30. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the duration of hypoxic ischemic encephalopathy (HIE) during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  31. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the number of infant's days with a central venous line in situ during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  32. 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).

    Time frame: At infant discharge date (immediately after the infant is discharged from the NICU)

    In NICU infants, does CNH+, when compared to standard care, change the number of infant central line-associated bloodstream infections during their stay in the NICU? Data are collected routinely via the Canadian Neonatal Network and abstracted for study use.

  33. Infant neurological examination score at 18 months corrected gestational age

    Time frame: At 18 months of the infants corrected gestational age

    In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a neurological examination? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.

  34. Infant hearing assessment score at 18 months corrected gestational age

    Time frame: At 18 months of the infants corrected gestational age

    In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a hearing assessment? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.

  35. Infant vision assessment score at 18 months corrected gestational age

    Time frame: At 18 months of the infants corrected gestational age

    In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through a vision assessment? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.

  36. Infant development score at 18 months corrected gestational age

    Time frame: At 18 months of the infants corrected gestational age

    In NICU infants, does CNH+, when compared to standard care, improve infant neurodevelopment as measured through the Bayley Scales of Infant and Toddler Development? Data are measured and collected at routine follow-up in NICUs at 18 months corrected gestational age.

  37. Number of Chez NICU Home educational modules completed at 6 months after the discharge of the infant from the NICU.

    Time frame: At 6 months after the discharge of the infant from the NICU

    What number of Chez NICU Home educational modules are completed by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.

  38. Number of Chez NICU Home educational modules viewed at 6 months after the discharge of the infant from the NICU.

    Time frame: At 6 months after the discharge of the infant from the NICU

    What number of Chez NICU Home educational modules are viewed by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.

  39. Amount of time spent on the Chez NICU Home platform at 6 months after the discharge of the infant from the NICU.

    Time frame: At 6 months after the discharge of the infant from the NICU

    What amount of time do parents of infants in the NICU spend on the Chez NICU Home platform, at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by the CNH platform.

  40. 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.

    Time frame: At 6 months after the discharge of the infant from the NICU

    What number of text messages are received by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by TextIt application.

  41. 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.

    Time frame: At 6 months after the discharge of the infant from the NICU

    What number of virtual communication tools are used by parents of infants in the NICU at 6 months after the discharge of the infant from the NICU? Metrics data will be captured by CNH+.

  42. Number of parents of infants in the NICU who enroll in CNH+ when offered?

    Time frame: At baseline (upon enrollment to the study)

    What number of parents of infants in the NICU who enroll in CNH+ when offered at the beginning of the study?

  43. 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)

    Time frame: At 6 months after the discharge of the infant from the NICU

    In parents of NICU infants, what are parents' perceived ease of use of the CNH+ intervention at 6 months after the discharge of the infant from the NICU)? Measured using the e-Health impact questionnaire tool 6 months after the discharge of the infant from the NICU. The primary parent/caregiver(s) will be asked to complete this measure. When scored, the e-Health impact questionnaire tool has a minimum score of 0 and a maximum score of 100. A higher score indicates a better outcome (higher levels of perceived ease of use).

Study contacts

Contact information is provided by the study sponsor or research team.

Cameron J Bruce, MSc

CONTACT

[email protected]

902 470 2640

Marsha Campbell-Yeo, RN NNP PhD

CONTACT

[email protected]

902 430 6447

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 11, 2023
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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