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Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application

10. Oktober 2018 aktualisiert von: Mai-Britt Hägi-Pedersen

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

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

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

186

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Herning, Dänemark, 7400
        • Herning Neonatal
      • Næstved, Dänemark, 4700
        • Neonatal
      • Roskilde, Dänemark, 4000
        • Neonatal
      • Viborg, Dänemark, 8800
        • Neonatal

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control group
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.
Experimental: App group/intervention group
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Proportion of breastfeeding
Zeitfenster: one month after discharge
one month after discharge

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Parents feeling of confidence
Zeitfenster: one month after discharge
one month after discharge
Parent/child interaction
Zeitfenster: one month after discharge
one month after discharge
Active knowledge concerning the premature infant
Zeitfenster: one month after discharge
one month after discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2015

Primärer Abschluss (Tatsächlich)

1. Oktober 2018

Studienabschluss (Tatsächlich)

1. Oktober 2018

Studienanmeldedaten

Zuerst eingereicht

19. Oktober 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Oktober 2015

Zuerst gepostet (Schätzen)

21. Oktober 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Oktober 2018

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PreHomeCare

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