CClinicalTrials.gg
Status unknownNCT03554512Updated Jun 13, 2018

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

An interventional study of Telehealth virtual appointment in Anxiety and Self Efficacy, sponsored by Horizon Health Network. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2018-06-13.

Sponsored by Horizon Health Network · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety
  • Self Efficacy

Keywords

  • Neonatal Intensive Care
  • Telehealth
  • Anxiety
  • Self Efficacy
  • Parenting/psychology
03

In context

Lead sponsor

Horizon Health Network is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Infant discharged to foster care.
  • Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • No intervention
    Standard of Care

    No Intervention

  • Experimental
    Telehealth

    Telehealth virtual appointment

    Other: Telehealth virtual appointment

Interventions

  • OtherTelehealth virtual appointment

    Appointment with NICU clinician via telehealth equipment.

06

What researchers measure

Primary outcomes

  1. The State-Trait Anxiety Inventory

    Time frame: Change from Baseline State-Trait Anxiety at 3 months

  2. The Maternal Confidence Questionnaire

    Time frame: Change from Baseline self-efficacy at 3 months

07

Study locations

1 site
  • Saint John Regional Hospital
    Saint John, New Brunswick E2L 4L2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03554512
Lead sponsor
Horizon Health Network
Collaborators
Canada Health Infoway
Responsible party
Sponsor
First posted
Jun 13, 2018
Start date
Jul 1, 2017
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Jun 13, 2018

Study contacts

Cecil Ojah, MD
principal investigator · Horizon Health Network

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion