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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03554512
• Other study ID #: CHSTHCHHN02
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 2018

Study information

• Verified date: May 2018
• Source: Horizon Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Self Efficacy

Intervention

Other:
• Telehealth virtual appointment
Appointment with NICU clinician via telehealth equipment.

Locations

Country	Name	City	State
Canada	Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (2)

Lead Sponsor	Collaborator
Horizon Health Network	Canada Health Infoway

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The State-Trait Anxiety Inventory		Change from Baseline State-Trait Anxiety at 3 months
Primary	The Maternal Confidence Questionnaire		Change from Baseline self-efficacy at 3 months