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TelePremie: Telehomecare for Step-down Care Post-NICU Discharge

TelePremie: Telehomecare for Step-down Care Post-NICU Discharge

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03554512
Enrollment
37
Registered
2018-06-13
Start date
2017-07-01
Completion date
2018-07-31
Last updated
2018-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Self Efficacy

Keywords

Neonatal Intensive Care, Telehealth, Anxiety, Self Efficacy, Parenting/psychology

Brief summary

Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge. Participants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant. The study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge. A subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention. The cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.

Interventions

OTHERTelehealth virtual appointment

Appointment with NICU clinician via telehealth equipment.

Sponsors

Canada Health Infoway
CollaboratorOTHER
Horizon Health Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Parent-infant pairs admitted to neonatal intensive care unit where study is conducted. * Parent has internet access. * Parent has literacy level such that they are comfortable reading and filling out surveys. * Infant is likely to survive.

Exclusion criteria

* Infant discharged to foster care. * Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.

Design outcomes

Primary

MeasureTime frame
The State-Trait Anxiety InventoryChange from Baseline State-Trait Anxiety at 3 months
The Maternal Confidence QuestionnaireChange from Baseline self-efficacy at 3 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026