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NCT Number: NCT06903052

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

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.

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Key information

Conditions

Child With Medical Complexity Mobile Application Nurse-led Supportive Care Self Efficacy Symptom Management

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing The Hong Kong Polytechnic University

Kowloon, 852, Hong Kong

Location status: Recruiting

Location contact

Winsome YY LAM, PhD

CONTACT

[email protected]

852-2766-4291

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria for parents are:

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

The exclusion criteria for parents are:

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

Treatment and study plan

Nurse parental support using a proactive mobile App

Device

Nurse parental support using a proactive mobile App in symptom management for child with mechanical ventilation

Primary outcomes

  1. Caregiving Self-efficacy

    Time frame: 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.

  2. Implementation evaluation

    Time frame: 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:

    • 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

Secondary outcomes

  1. Modified Memorial Symptom Assessment Scale

    Time frame: 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).

  2. Children health service utilization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Winsome Lam, PhD

CONTACT

[email protected]

852-2766 ext. 4291

Winsome Lam, PhD

CONTACT

[email protected]

(852)2766 ext. 4291

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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