Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04315610
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2019-10-16
Brief Title:
Personalized Mobile App for Parents of Infants With Cardiac Disease
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Personalized Mobile App for Parents of Infants With Cardiac Disease
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOBS
Brief 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
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
Detailed 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 childs health and wellbeing deteriorates3
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 personnels 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 wwwhobsno 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 infants needs Under the guidance of nurses at the NICD at OUH parents are trained using the app to assess their infants 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 infants 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 applications 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
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 childs health and wellbeing deteriorates3
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 personnels 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 wwwhobsno 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 infants needs Under the guidance of nurses at the NICD at OUH parents are trained using the app to assess their infants 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 infants 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 applications 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None