Child With Medical ComplexityNCT06903052
Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children With Mechanical Ventilation
A study testing Nurse parental support using a proactive mobile App in people with Child With Medical Complexity and Symptom Management, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Child With Medical Complexity, Symptom Management, Self Efficacy
- What is being tested?
- Nurse parental support using a proactive mobile App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 May 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing The Hong Kong Polytechnic University
Kowloon, Kowloon, 852
Winsome YY LAM, PhD, 852-2766-4291, winsome.lam@polyu.edu.hk
About this study
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
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.
Read the 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.
- Conditions
- Child With Medical Complexity, Symptom Management, Self Efficacy, Mobile Application, Nurse-led Supportive Care
- Being tested
- Nurse parental support using a proactive mobile App
- Keywords
- parental self-efficacy, children requiring mechanical ventilation, symptom management, mobile application, nurse-led parental support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse parental support using a proactive mobile AppDevice
Nurse parental support using a proactive mobile App in symptom management for child with mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Nurse parental support using a proactive mobile App | Experimental | Nurse parental support using a proactive mobile App in symptom management for children with mechanical ventilation for a 3-month period. Receives: Device: Nurse parental support using a proactive mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: month 9
Secondary outcomes (2)
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).
Measured: 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.
Measured: Day 0, Month 3, Month 6, Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start6 May 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child With Medical ComplexityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nurse parental support using a proactive mobile App in symptom management for children requiring mechanical ventilation
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Winsome Lam, The Hong Kong Polytechnic University
- Investigators
- Winsome LAM, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903052
- Sponsor's protocol ID
- SNHongkongPOLYU
- Other IDs
- Ref: 22231361
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD collected throughout the study, only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06903052
- Acronym / sponsor ID
- SNHongkongPOLYU
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nurse parental support using a proactive mobile App in symptom management for children requiring mechanical ventilation
| Arm | Type | Receives |
|---|---|---|
| Nurse parental support using a proactive mobile App | Experimental | Device: Nurse parental support using a proactive mobile AppNurse parental support using a proactive mobile App in symptom management for children with mechanical ventilation for a 3-month period. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse parental support using a proactive mobile AppNurse parental support using a proactive mobile App in symptom management for child with mechanical ventilation | Device | Nurse parental support using a proactive mobile App |
Primary outcome
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.
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: 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
2 secondary outcomes
Modified Memorial Symptom Assessment Scale
Time frame: Day 0, Month 3, Month 6, Month 9
Children health service utilization
Time frame: Day 0, Month 3, Month 6, Month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. IPD collected throughout the study, only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winsome LAM, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse parental support using a proactive mobile App in people with Child With Medical Complexity and Symptom Management, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winsome Lam, PhD (852-2766 ext. 4291, winsome.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiving Self-efficacy (time frame: Day 0, Month 3, Month 6, Month 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.