Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02581800
Other study ID # PreHomeCare
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date October 2018

Study information

Verified date October 2018
Source Naestved Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 BrinkmannĀ“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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Other:
App group


Locations

Country Name City State
Denmark Herning Neonatal Herning
Denmark Neonatal Næstved
Denmark Neonatal Roskilde
Denmark Neonatal Viborg

Sponsors (1)

Lead Sponsor Collaborator
Mai-Britt Hägi-Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of breastfeeding one month after discharge
Secondary Parents feeling of confidence one month after discharge
Secondary Parent/child interaction one month after discharge
Secondary Active knowledge concerning the premature infant one month after discharge
See also
  Status Clinical Trial Phase
Completed NCT00579605 - Motivational Interviewing to Promote Sustained Breastfeeding N/A
Completed NCT05655364 - Development of a Breastfeeding Supportive Mobile Application N/A
Completed NCT03853850 - Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island N/A
Completed NCT03957941 - FamilyLink and Breastfeeding N/A
Withdrawn NCT03709004 - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression N/A
Completed NCT02958475 - Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers N/A
Active, not recruiting NCT05503069 - Community Interventions to Improve Breastfeeding N/A
Not yet recruiting NCT02233439 - Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues N/A
Completed NCT01893736 - Professional Breastfeeding Support Intervention N/A
Completed NCT02738957 - Effect of Prenatal Counseling on Breastfeeding Rates in Twins N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Completed NCT03655314 - Using the Electronic Health Record to Guide Management of Newborn Weight Loss N/A
Completed NCT05562245 - Motivational Interviewing-Based Breastfeeding Education N/A
Completed NCT05106634 - Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Recruiting NCT05213975 - Kinesio Taping Application After Cesarean Section N/A
Recruiting NCT05250219 - Microchimeric Cell Tranfer From Mother to Child - Pilo Study
Recruiting NCT05371106 - Mycotoxins in Mothers Milk in Israel
Completed NCT03332108 - Novel Approach To Improving Lactation Support With Mobile Health Technology N/A
Completed NCT02901665 - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes N/A