Personalized Mobile App for Parents of Infants With Cardiac Disease

NCT04315610 | Completed

• 1 other identifier: 19/23041
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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 pragmatic controlled trial. 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.

Conditions

Congenital Heart Disease in Children; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Pediatric Inventory for Parents (PIP)

  The PIP measures parental stress related to children with chronic disease and is the primary endpoint regarding psychological adaption. It contains 42 items that are answered on a 5-point Likert scale within four domains: 1) communication, 2) emotional distance, 3) medical care and 4) role function. All items are answered twice, one for frequency and one for difficulty. Higher score reflects more disease-related stress. The instrument has shown good reliability and content validity. The instrument can provide answers about the causes and degree of stress and anxiety. The instrument has been translated into Norwegian using acknowledged methods.

  Baseline, 1 and 4 months

Secondary Outcomes (6)

• Health literacy Questionnaire (HLQ)

  4 months

• Post Discharge Coping Difficulty Scale (PDCDS)

  1 month

• Edinburgh postnatal depression scale (EPDS)

  Baseline, 1 and 4 months

• Quality of discharge teaching scale (QDTS)

  At discharge from local hospital (up to 5 days)

• Readiness for hospital discharge (RHDS)

  At discharge from local hospital (up to 5 days)

Study Arms (2)

Access to mobile application

EXPERIMENTAL

This application will help parents to recognize symptoms of reduced health status in their infant, provide decision-making support, increase their communication skills with health professionals, and provide easier access to quality assured information. At first login, the diagnosis, treatment, and contacts in the health service are registered to provide parents with personalized information that is adapted to their infant's needs. Under the guidance of healthcare personnel at the Neonatal Intensive Care Department (NICD) at Oslo University Hospital (OUH), parents are trained to assess their infant's condition, regarding circulation, breathing, eating habits, well-being, and more. In addition, before discharge, a baseline assessment of the infant's condition is stored in the application.

Other: Access to mobile phone application

Treatment as usual

ACTIVE COMPARATOR

This group receives traditional oral and written information about their child's heart defect and further follow-up.

Other: Treatment as usual

Interventions

Access to mobile phone application OTHER

Under the guidance of healthcare personnel at the Neonatal Intensive Care Department (NICD) at Oslo University Hospital (OUH), parents are trained to assess their infant's condition, regarding circulation, breathing, eating habits, well-being, and more. In addition, before discharge, a baseline assessment of the infant's condition is stored in the application. After discharge, assessments using the application are performed if necessary.

Access to mobile application

Treatment as usual OTHER

Active comparator group, based on traditional information and follow-up.

Treatment as usual

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants below 3 months age diagnosed with severe heart disease at NICD at OUH

You may not qualify if:

• a) Gestational age below 34 weeks b) Isolated arrhythmic disorders c) Language barriers d) Need of advanced home care with professional assistance

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Association for Children with Congenital Heart Disease (FFHB): collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (3)

• Hjorth-Johansen E, Borosund E, Martinsen Osten I, Holmstrom H, Moen A. Acceptability and Initial Adoption of the Heart Observation App for Infants With Congenital Heart Disease: Qualitative Study. JMIR Form Res. 2023 Apr 5;7:e45920. doi: 10.2196/45920.

  PMID: 37018028 BACKGROUND

• Hjorth-Johansen E, Borosund E, Moen A, Harmens A, Martinsen I, Wik G, Fredriksen BE, Eger SHW, Holmstrom H. Heart OBServation app: development of a decision support tool for parents of infants with severe cardiac disease. Cardiol Young. 2023 Aug;33(8):1350-1358. doi: 10.1017/S1047951122002438. Epub 2022 Aug 8.

  PMID: 35938297 BACKGROUND

• Hjorth-Johansen E, Borosund E, Moen A, Osten IM, Wik G, Solevag AL, Eger SHW, Holmstrom H. An individualised mobile app was beneficial for the mothers of infants with severe congenital heart defects. Acta Paediatr. 2025 Jun;114(6):1238-1248. doi: 10.1111/apa.17556. Epub 2024 Dec 21.

  PMID: 39707745 RESULT

MeSH Terms

Conditions

Stress, Psychological

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: March 19, 2020
• Study Start: June 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)