Clinical trial NCT02581800: Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application
Official title: Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application: A Randomized Intervention Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants, Premature
Breastfeeding
Telecommunication
Patient Discharge
Nursing
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Increases proportion of exclusive breastfeeding.
2. Improves parent/infant interaction (MABISC-mother and baby interaction scale).
3. Enhances the families' feeling of confidence in caring for their infant (KPCS - Karitane parenting confidence scale).
4. Increases parent's knowledge with regarding the premature infant and the care. Parents will be randomized to either intervention or control group via simple randomization procedure.

The intervention group will receive a mobile application and videoconference system. The application contains three parts; 1) knowledge, 2) video contact/participatory guidance and 3) data registration.

Sample Size: Applying a significance level of 5%, a two-sided two-sample proportions test revealed that a sample size of 39 in each group maintains a power of 80% to detect the difference consisting of 55% vs. 40% breastfeeding women in the two groups after 4 weeks conditional on 66% breastfeeding at discharge. This corresponds to a sample size of 65 at randomisation. To compensate for the design effect ICC(0.01) the total sample size needed is thus approximately 160 preterm infants, 80 in each group.

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 patents (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 observations of the parent-infant relationship.

Data analysis; the results of the intervention and control group will be compared and analysed following "intention to treat" principle.

Qualitative evaluation:

Sub study 1: A field observational study: The aim is describe what characterizes nursing practice in PreHomeCare from the parents' angle in home around video consultations. Method will be based on Spradley "participant observation". The focus for the observation is the nurses' communication, how is her act on the screen etc. The field observations are expected to enlighten the characteristics of the nursing practice with a systematic description of PreHomeCare setting using video consultations. The prose text will be analysed following Ricoeur.

Sub study 2: An interview study: The aim is to explore how parents of premature infants experience PreHomeCare with use of video communication and mobile application. The study will be planned and conducted with inspiration from Kvale and Brinkmann´s instructions. The main focus for the interview will be to uncover the main question: "How did you experience PreHomeCare?" with a particular focus on what have been especially meaningful for the parents under PreHomeCare. The verbatim transcribed material will be analysed following Ricoeur interpretations theory.

Perspectives: This study will access new knowledge on the effect and experience with PreHomeCare. It will give insight in what is needed to make clear goals for the quality of the treatment and care for premature infants and parents in the last part of the admission/PreHomeCare. It is expected that this project will be an argument in further development of care for premature infants and telemedicine use in the future. The increased effectiveness can address challenges and help relocate economic and professional health services.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of breastfeeding
timeFrame: one month after discharge
Secondary outcomes:
measure: Parents feeling of confidence
timeFrame: one month after discharge
measure: Parent/child interaction
timeFrame: one month after discharge
measure: Active knowledge concerning the premature infant
timeFrame: one month after discharge
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Herning Neonatal
city: Næstved
country: Denmark
facility: Neonatal
city: Roskilde
country: Denmark
facility: Neonatal
city: Viborg
country: Denmark
facility: Neonatal
Study officials:
References:
citation: Hagi-Pedersen MB, Dessau RB, Norlyk A, Stanchev H, Kronborg H. Comparison of video and in-hospital consultations during early in-home care for premature infants and their families: A randomised trial. J Telemed Telecare. 2022 Jan;28(1):24-36. doi: 10.1177/1357633X20913411. Epub 2020 Mar 30.
citation: Hagi-Pedersen MB, Norlyk A, Dessau R, Stanchev H, Kronborg H. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations: protocol of the PreHomeCare study. BMJ Open. 2017 Mar 9;7(3):e013024. doi: 10.1136/bmjopen-2016-013024.