Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children With Mechanical Ventilation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Self Efficacy; Mobile Application; Symptom Management; Nurse-led Supportive Care; Child With Medical Complexity
• Intervention / Treatment: Device: Nurse parental support using a proactive mobile App

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winsome Lam, PhD; Phone Number: 4291 852-2766; Email: winsome.lam@polyu.edu.hk
• Study Contact Backup: Name: Winsome Lam, PhD; Phone Number: 4291 (852)2766; Email: winsome.lam@polyu.edu.hk

Study Locations

• Hong Kong
  • Kowloon, Hong Kong, 852
    • Recruiting
    • School of Nursing The Hong Kong Polytechnic University
    • Contact: Winsome YY LAM, PhD; Phone Number: 852-2766-4291; Email: winsome.lam@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse parental support using a proactive mobile App; Nurse parental support using a proactive mobile App in symptom management for children with mechanical ventilation for a 3-month period.	Device: Nurse parental support using a proactive mobile App; Nurse parental support using a proactive mobile App in symptom management for child with mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiving Self-efficacy	The scale consists of 18 items to measure the self-efficacy of Chinese caregivers. It is rated on a 9-point scale, with 1= no confidence, to 9 =full confidence.	Day 0, Month 3, Month 6, Month 9
Implementation evaluation	Semi-structured interviews will be conducted to the related community stakeholders to evaluate the quality of service provided. Semi-structured interview guide will be used to collect qualitative data in four perspectives including: reach: document the number of participants, and retention in the intervention; adoption: seek to find out if the intervention is appropriate and in action; implementation: understand stakeholders' perception if the intervention is acceptable and implemented as planned; maintenance: explore the facilitators and barriers in the sustainability of the nurse parental support using a proactive mobile app	month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Memorial Symptom Assessment Scale	This is a modified 40-item Memorial Symptom Assessment Scale (MSAS in Chinese version). The items for measuring the frequency and severity of symptoms are rated on a 4-point Likert scale from one (almost never) to four (always). The items for measuring distress are rated on a 5-point Likert scale from one (not at all) to five (very).	Day 0, Month 3, Month 6, Month 9
Children health service utilization	This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.	Day 0, Month 3, Month 6, Month 9

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Winsome LAM, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: symptom management; mobile application; parental self-efficacy; children requiring mechanical ventilation; nurse-led parental support
• Other Study ID Numbers: SNHongkongPOLYU; Ref: 22231361 (Other Grant/Funding Number: Health and Medical Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD collected throughout the study, only IPD used in the results publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No