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Clinical Trials/NCT02581800
NCT02581800CompletedNot Applicable

Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application: A Randomized Intervention Study.

Mai-Britt Hägi-Pedersen4 sites in 1 country186 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
186
Locations
4
Primary Endpoint
Proportion of breastfeeding

Study Overview

Brief Summary

Background: Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs. Research regarding the use of health IT is needed to say, whether the use of videoconference and Smartphone application is a viable option to address the parents need for support in relations to early discharge.

Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile application versus hospital consultations.

Method: Main study; a randomized controlled intervention study with the hypothesis; parent of premature infants who have access to electronic knowledge and participatory guidance 24-7: increases proportion of exclusive breastfeeding, Improves parent/infant interaction, enhances confidence and increases knowledge.

Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected that this project will be an argument in development of care for premature infants and telemedicine use in the future

Detailed Description

Effect and experience of PreHomeCare of preterm infants using telecommunication and Smartphone application: A randomized intervention study.

Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs.

Effect studies of early in-homecare point towards that premature infants have lower risk of infections under the period of tube feeding, higher parental satisfaction and indicate that early in-homecare of premature infants benefit of home visits with fewer readmissions and less unscheduled support, shorter length of hospital stay and longer provision of breast milk. Standard procedure in early in-homecare is home visits but in regions of Denmark with large distances to the parent/infant this is not possible. No studies have until now offered 24-7 hours home visit support. Further research regarding the use of health IT is needed to say, whether the use of videoconference (participatory guidance) and Smartphone application (knowledge and data registration) is a viable option to address the parents need for support in relations to early discharge.

Main Study: A randomized controlled intervention study. The aim is to test the effect of the use of video communication and mobile application on exclusive breastfeeding, parent/infant interaction and parental confidence with the premature infants after PreHomeCare.

Hypothesis; Compared to parents of premature infants who receive hospital consultations, the parents of premature infants who have access to electronic knowledge and participatory guidance 24-7:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Infants who fulfil criteria for early in-home care. GA > 34+0, No need for monitoring, tube feeding and started breastfeeding/bottle feeding, Danish speaking or English speaking patients (but understand the Danish text in the application).

Exclusion Criteria

  • •Infants who do not fulfil criteria for early in-home care and parents, who require extra observation of the par-ent-infant relationship.

Arms & Interventions

Control group

No Intervention

The control group includes hospital consultations (usual care) on the hospital 2-3 times a week (1-2 hours) and the possibility to call the neonatal ward 24 hours a day all week until the infant gets full nutrition from the breast or bottle and gains weight. The parents register nutrition on a paper between the visits to the hospital.

App group/intervention group

Experimental

The intervention group will receive the Smartphone application at inclusion time and learn to use it in the hos-pital. When the families go home they will use the application and receive planned video consultations 2-3 times a week and the possibility to call the neonatal ward 24 hours a day all week whenever needed, until the infant gets full nutrition from the breast or bottle and gains weight. Parents will borrow a baby weight to weigh the baby at home.

Intervention: App group (Other)

Outcomes

Primary Outcomes

Proportion of breastfeeding

Time Frame: one month after discharge

Secondary Outcomes

  • Active knowledge concerning the premature infant(one month after discharge)
  • Parents feeling of confidence(one month after discharge)
  • Parent/child interaction(one month after discharge)

Investigators

Sponsor
Mai-Britt Hägi-Pedersen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mai-Britt Hägi-Pedersen

MSN, ICU nurse, phd student

Naestved Hospital

Study Sites (4)

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