Clinical trial NCT06903052: Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children With Mechanical Ventilation
Official title: Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children With Medical Complexity Requiring Mechanical Ventilation: an Effectiveness-implementation Hybrid 2 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child With Medical Complexity
Symptom Management
Self Efficacy
Mobile Application
Nurse-led Supportive Care
Keywords: parental self-efficacy
children requiring mechanical ventilation
symptom management
mobile application
nurse-led parental support
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nurse parental support using a proactive mobile App in symptom management for children requiring mechanical ventilation
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this study are to test the effectiveness of a nurse support using a proactive mobile app to enhance parental self-efficacy in symptom management for children using mechanical ventilations, and alongside identify factors facilitating or deterring the program implementation.

A single group pre-post quasi-experimental study on parents of CMC requiring mechanical ventilation.

Parents will be recruited from a non-government office, with an estimated sample size of 52 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.

Detailed description: Parents of children required mechanical ventilations at risk of high stress levels because these children have multisystem diseases, including severe neurologic conditions, resulting in potential premature death. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve the child's health.

Nurse parental support in symptom management using a proactive mobile health application is an alternative method considered more accessible and nurse-parent interactivity to continue home-based support for the CMC and parents.

Self-administrated questionnaire, and semi-structured interview guide will be used for data collection. Descriptive statistics, including proportions for categorical variables, mean, and SD for normally distributed continuous variables, and median and inter-quartile range for non-normally distributed variables, will be reported. Generalized estimating equation will be used to address the objectives with appropriate link function. Qualitative data will be analyzed using thematic analysis to identify the facilitator, and barriers of program implementation.

Eligibility criteria: The inclusion criteria for parents are:

1. parent of a child with mechanical ventilation aged 2-18
2. having a Smartphone
3. able to communicate in Chinese and read Chinese
4. living with his/her child at home.

The exclusion criteria for parents are:

1. a reported mental health disorder
2. engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.

Primary outcomes:
measure: Caregiving Self-efficacy
timeFrame: Day 0, Month 3, Month 6, Month 9
measure: Implementation evaluation
timeFrame: month 9
Secondary outcomes:
measure: Modified Memorial Symptom Assessment Scale
timeFrame: Day 0, Month 3, Month 6, Month 9
measure: Children health service utilization
timeFrame: Day 0, Month 3, Month 6, Month 9
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: School of Nursing The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Winsome LAM, PhD
role: PRINCIPAL_INVESTIGATOR
References: