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

NCT03554512 | Unknown

• 1 other identifier: CHSTHCHHN02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Self Efficacy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The State-Trait Anxiety Inventory

  Change from Baseline State-Trait Anxiety at 3 months

• The Maternal Confidence Questionnaire

  Change from Baseline self-efficacy at 3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

No Intervention

Telehealth

EXPERIMENTAL

Telehealth virtual appointment

Other: Telehealth virtual appointment

Interventions

Telehealth virtual appointment OTHER

Appointment with NICU clinician via telehealth equipment.

Telehealth

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Horizon Health Network: lead
• Canada Health Infoway: collaborator

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Cecil Ojah, MD

  Horizon Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 13, 2018
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)