跳至主要内容
临床试验/NCT03554512
NCT03554512Unknown不适用

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

Horizon Health Network2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
37
试验地点
2
主要终点
The State-Trait Anxiety Inventory

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Standard of Care

No Intervention

No Intervention

Telehealth

Experimental

Telehealth virtual appointment

干预措施: Telehealth virtual appointment (Other)

结局指标

主要结局

The State-Trait Anxiety Inventory

时间窗: Change from Baseline State-Trait Anxiety at 3 months

The Maternal Confidence Questionnaire

时间窗: Change from Baseline self-efficacy at 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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