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

Not Applicable

Not yet recruiting

• Conditions: Child with Medical Complexity; Symptom Management; Self Efficacy; Mobile Application; Nurse-led Supportive Care

• Registration Number: NCT06903052
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-05-06
• Primary Completion: 2027-12-31
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Implementation evaluation	month 9	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: 1. reach: document the number of participants, and retention in the intervention; 2. adoption: seek to find out if the intervention is appropriate and in action; 3. implementation: understand stakeholders' perception if the intervention is acceptable and implemented as planned; 4. maintenance: explore the facilitators and barriers in the sustainability of the nurse parental support using a proactive mobile app
Caregiving Self-efficacy	Day 0, Month 3, Month 6, Month 9	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.

Secondary Outcome Measures

Name	Time	Method
Modified Memorial Symptom Assessment Scale	Day 0, Month 3, Month 6, Month 9	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).
Children health service utilization	Day 0, Month 3, Month 6, Month 9	This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.