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Clinical Trial Summary

This project implements an eHealth intervention targeted at vulnerable infants with cardiac disease and specifically study how this intervention impact their parents coping, stress levels and personal wellbeing. The intervention will be evaluated through a randomized controlled trial (RCT). The aim of this project is therefore to measure if the features of this mobile application are useful for parents' assessment of deterioration, decision-making and communication with health care providers.


Clinical Trial Description

This project is a service innovation project where the overall aim is to stimulate service innovation that ensures patient safety to vulnerable infants with severe cardiac disease. We plan to implement and evaluate an eHealth intervention, called HOBS (the Heart OBServation-app), that systemizes and personalizes information and teaching from nurses and other health personnel in order to support parents as caregivers after discharge from hospital. The service innovation will be studied in two consecutive studies; 1) a feasibility study to examine health personnel and parents in-depth perception of relevance, benefit and user friendliness of the application and its features, and 2) a controlled trial to measure the applications impact on parents stress, anxiety, coping and health literacy after discharge, including reasons and outcomes of contact with health services. In addition, we evaluate if nurses' quality of discharge teaching is affected by the application. In Norway, 500-600 children are born with congenital heart defects (CHD) every year. About 25% of these children present severe problems and symptoms in need of early treatment (1), and 15 % of them die during the first year of life (2). Parents of infants with cardiac disease assume significant, comprehensive caregiving responsibilities, and have shown higher levels of anxiety, depression, and stress. Many parents find it difficult to recognize the symptoms if their child's health and wellbeing deteriorates(3). New, mobile technology applications and services come with novel opportunities to support these parents with personalized, contextual information at the point of need. For example, interactive functions and presentation of selected information can enable personalized decision-making and communication support. This can improve relevance and quality of discharge teaching from nurses at Neonatal Intensive Care Department (NICD) at Oslo University Hospital (OUH), but more importantly also support local services where CHD seldom occur and knowledge may be sparse. To date, the value added, appropriateness and importance of such opportunities for mental stress and health competence among parents of children with CHD has not been systematically reported. Moreover, if our study goals are achieved, the intervention can empower parents to recognize the early signs before deterioration in their infant manifests, prevent acute episodes at home after discharge, and improve rehabilitation. For the parents this service innovation may reduce psychological strain during a challenging period of life. Method and data collection A controlled trial with consecutive groups has been chosen to avoid contamination of health personnel's way of guiding and parents interaction at common rooms at the NICD. Even though the access to or use of the application are controlled by the project using a login code we accept that guidance will be affected and more systematic during the implementation of the application and this may affect the results. Hence, a two months break between the last family receiving app in the quality study at OUH and inclusion of the control group is planned. Inclusion of the control group will then be conducted before inclusion of the app group. The control group receives written information in a binder while the intervention group will receive the information through links in the mobile application. A guideline including a checklist of topics to support parents before discharge is similar to both groups. The intervention HOBS-app is developed by a project group at OUH together with parents and local health personnel for parents with infants with cardiac disease. It is presented in detail at the web-page www.hobs.no. Congenital heart disease is a complicated and individual diagnosis with varied consequences (15). Therefore, at first login, the diagnosis and treatments are registered. Then an algorithm in the application provides parents with a personalized set of observations and a list of adapted information to their infant's needs. Under the guidance of nurses at the NICD at OUH, parents are trained using the app to assess their infant's condition, regarding circulation, breathing, eating habits, well-being, wound healing and more. These observations are stored in the application. In this way parents become better aware of their infant's condition and may help parents to detect signs of deterioration at home. Contact information to local health services is stored before discharge. After discharge, assessments using the application are performed before consultations to health services or if parents are uncertain about deterioration in their infant. After assessments the applications' function for communication support can guide parents in describing a possible deterioration and communication with health personnel may be facilitated. To reach health professionals with information about HOBS a website will be established with guidance and tips on using the app. An e-learning course is developed and will be distributed nationally through similar educative portals. A link to the website and the e-learning courses are added to the discharge summary that follows the infant to a local hospital. The purpose of the controlled trial is to answer research question 3: In what ways do the application's content and functionality influence the parents' coping with stress, anxiety, distress of caring for a sick child and health literacy and contact with health services? ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04315610
Study type Interventional
Source Oslo University Hospital
Contact Elin Hjorth-Johansen, Master
Phone +4798676884
Email ehjorth@ous-hf.no
Status Recruiting
Phase N/A
Start date June 1, 2021
Completion date December 31, 2024

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