Brief Summary

The overall aim is twofold: 1) to stretch the borderline regarding the present knowledge of clinical and economic cost-effectiveness of eHealth as an aid for facilitating and supporting self-management in families with long-term childhood illness, and 2) to develop a sustainable multidisciplinary research environment for advancing, evaluating, and implementing models of eHealth to promote self-management for children and their families. A number of clinical studies are planned for, covering different parts of paediatric healthcare. The concept of child-centred care is essential. Experienced researchers from care science, medicine, economics, technology, and social science will collaborate around common issues. Expertise on IT technology will analyse the preconditions for using IT; economic evaluations will be performed alongside clinical studies; and cultural and implementation perspectives will be used to analyse the challenges that arise from the changes in relations among children, family and professionals, which may occur as a result of the introduction of eHealth. Child health is not only important in itself. Investments in child health may also generate significant future gains, such as improved educational and labour market performance. Six complex, long-term and costly challenges in paediatric healthcare are planned for, involving eHealth technology such as interactive video consultation, pictures, on-line monitoring, and textual communication. The research follows an international framework for developing and evaluating complex interventions in healthcare. End-users (families) and relevant care providers (professionals in health and social care) will participate throughout the research process. The overall aim is certainly to analyse eHealth as an aid for facilitating and supporting self-management. However, the plan also includes the research issue whether eHealth at the same time improves the allocation of scarce health care- and societal resources.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

420

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach

2 countries

6 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

Study Start

First participant enrolled

October 15, 2019

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed

14 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

October 21, 2019

Last Update Submit

December 7, 2022

Conditions

Preterm Birth Pediatric Cancer Hirschsprung Disease Congenital Malformation Congenital Heart Disease Nutrition Disorder, Child

Keywords

e-healthchildrenculturehealth economyquality of lifehome care

Outcome Measures

Primary Outcomes (2)

The PedsQL Healthcare Satisfaction Generic Module
The PedsQL Healthcare Satisfaction Generic Module is composed of 24 items comprising 6 dimensions. Item scaling: 5-point Likert scale: 0 (Never) to 4 (Always) and Not Applicable. Higher scores indicate higher satisfaction. The scale includes the variables: information, family inclusion, communication, technical skills, emotional needs, and overall satisfaction.
After their participation in the study has ended, on average after 2-4 weeks.
Cost-utility ratios
Health economic variables
After their participation in the study has ended, on average after 2-4 weeks.

Secondary Outcomes (15)

The child's general and specific health status
Before the study begins and after their participation in the study has ended, on average after 2-4 weeks.
The PedsQL 2.0 Family Impact Module
After their participation in the study has ended, on average after 2-4 weeks.
The Parental Stress (Parental - Persistent Role Problems)
After their participation in the study has ended, on average after 2-4 weeks.
Adverse events that occurs during the study period
After their participation in the study has ended, on average after 2-4 weeks.
The Clavien-Dindo Classification
After their participation in the study has ended, on average after 2-4 weeks.
+10 more secondary outcomes

Study Arms (6)

Reconstructive paediatric surgery (Area I)

ACTIVE COMPARATOR

The overall incidence of congenital malformations in the gastrointestinal and urinary tract needing surgical interventions is about 1:1000 (Swedish national malformation registers) with a morbidity during childhood about 20-60%. Advanced paediatric surgery for the diagnosis Hirschsprung's disease, anorectal malformations, bladder extrophy, congenital diaphragmal hernia, and esophageal atresia is from July 2018 only performed at two NCSM in Sweden. The NCSM at Skåne University Hospital (SUS) in Lund forms one context. The quality of postoperative care is of immense importance both for short and long-term outcome. Legal guardians describe their situation after leaving the hospital as extremely stressful as they have not only to take responsibility for their new-born child but also of surgical wounds, medications, treatments, and special nutritional needs.