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Clinical Trials/NCT03554512
NCT03554512
Unknown
N/A

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

Horizon Health Network1 site in 1 country37 target enrollmentJuly 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Horizon Health Network
Enrollment
37
Locations
1
Primary Endpoint
The State-Trait Anxiety Inventory
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The State-Trait Anxiety Inventory

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

The Maternal Confidence Questionnaire

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

Study Sites (1)

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