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Children With Medical Complexity (CMC)NCT07652268

Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support

A study testing Nurse-led integrated home service in people with Children With Medical Complexity (CMC) and Symptom Management, run by Dr Winsome Lam at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aims of this study are to test the effectiveness of a nurse-led integrated home health service to enhance parental self-efficacy in symptom management for children requiring respiratory support, and alongside identify factors facilitating or deterring the program implementation. Read more about this study

Who is it for?
Ages 6 months to 22 years
What is being tested?
Nurse-led integrated home service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesin 2 countries
Study dates
2 Jul 2026to 30 Jun 2029
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 6 months to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • parent of a child with respiratory support aged 6-month to 22 years old
  • having a Smartphone
  • able to communicate in Chinese or in English
  • living with his/her child at home.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Winsome Lam, PhD contact

852-2766 ext. 4291

winsome.lam@polyu.edu.hk

2 sites in 2 countries

China1 site, 1 recruiting

  • School of Nursing The Hong Kong Polytechnic University

    Hong Kong, 852

    winsome Lam, PhD, 852-2766 ext. 4291, winsome.lam@polyu.edu.hk

    Not yet recruiting

Other trials in China

Hong Kong1 site, 1 recruiting

  • School of Nursing The Hong Kong Polytechnic University

    Hong Kong, Kowloon, 852

    winsome Lam, PhD, 852-2766 ext. 4291, winsome.lam@polyu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Nurse-led Integrated Home Health Service to Support Parents in Symptom Management for Children With Respiratory Support: an Effectiveness-implementation Hybrid II Study

The aims of this study are to test the effectiveness of a nurse-led integrated home health service to enhance parental self-efficacy in symptom management for children requiring respiratory support, and alongside identify factors facilitating or deterring the program implementation.

A single group pre-post quasi-experimental study on parents of CMC requiring respiratory support.

Parents will be recruited from non-government organizations, with an estimated sample size of 80 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.

Read the detailed description

Parents of children required respiratory support are 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-led integrated home health service in symptom management is an alternative method considered more comprehensive and health-parent interactivity to continue home-based support for these parents and their children.

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.

Being tested
Nurse-led integrated home service
Keywords
Children requiring respiratory support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse-led integrated home serviceOther

    Nurse-led integrated home service to support parents in Symptom Management for Children With Respiratory Support for a 3-month period.

Study groups in NCT07652268
Study groupRoleWhat they receive
Nurse-led integrated home serviceExperimentalNurse-led integrated home service to support parents in Symptom Management for Children With Respiratory Support for a 3-month period.
Receives: Other: Nurse-led integrated home service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Time Frame: Day 0, Month 3, Month 6

  2. 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:

    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-led integrated home service

    Measured: Time Frame: month 6

Secondary outcomes (3)

  1. 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). A higher score on each subscale indicates the child is experiencing more symptom burden.

    Measured: Time Frame: Day 0, Month 3, Month 6

  2. 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. Higher non-scheduled health visit rates mean the child's health condition worsen

    Measured: Time Frame: Day 0, Month 3, Month 6

  3. Depression Anxiety Stress Scale (DASS) (Chinese version)

    DASS is a self-report instrument consisting of 21 items used to assess the states of depression, anxiety and stress in parents. It is rated on a 4-point scale from 0 (does not apply to me at all) to 3 (applies to me very much, or most of the time). A higher score on each subscale indicates more severe symptoms of depression, anxiety and stress.

    Measured: Time Frame: Day 0, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start2 Jul 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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-led integrated home health service to support parents in Symptom Management for Children With Respiratory Support
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07652268
Sponsor's protocol ID
DonationHongKongPolyU
Status last verified
Jun 2026
First submitted
11 Jun 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Privacy

Publications

  • 1. Cohen, E., et al., Children with medical complexity: an emerging population for clinical and research initiatives. Pediatrics, 2011. 127(3): p. 529-538. 2. Chan, K.S., Palliative care: the need of the modern era. Hong Kong Med J, 2018. 24(4): p. 391-399. 3. Chung, W.W., et al., Improving Children's cancer pain management in the home setting: Development and formative evaluation of a web-based program for parents. Comput Biol Med, 2018. 101: p. 146-152. 4. Kun SS, Davidson-Ward SL, Hulse LM, Keens TG. How much do primary care givers know about tracheostomy and home ventilator emergency care? Pediatr Pulmonol. 2010 Mar;45(3):270-4. doi: 10.1002/ppul.21169. PMID: 20146395. 5. Truitt BA, Ghosh RN, Price EW, Du C, Bai S, Greene D, Simon DM, Reeder W, Kasi AS. Family Caregiver Knowledge in the Outpatient Management of Pediatric Tracheostomy-Related Emergencies. Clin Pediatr (Phila). 2025 Jul;64(7):936-943. doi: 10.1177/00099228241304480. Epub 2024 Dec 20. PMID: 39707594. 6. Wang, J., et al., Supporting Caregivers of Children With Acute Lymphoblastic Leukemia via a Smartphone App: A Pilot Study of Usability and Effectiveness. Comput Inform Nurs, 2016. 34(11): p. 520-527. 7. Bandura, A., Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev, 1977. 84(2): p. 191-215. 8. Kwok and Wong, Mental health of parents with young children in Hong Kong: The roles of parenting stress and parenting self-efficacy. Child & Family Social Work, 2000. 5(1): p. 57-65. 9. Streisand, R., et al., Pediatric parenting stress among parents of children with type 1 diabetes: the role of self-efficacy, responsibility, and fear. J Pediatr Psychol, 2005. 30(6): p. 513-21. 10. World Health Organization mHealth: new horizons for health through mobile technologies 2011. 11. Crable, E.L., et al., Standardizing an approach to the evaluation of implementation science proposals. Implement Sci, 2018. 13(1): p. 71. 12. Curran, G.M., et al., Effectiveness-implementation hybrid designs: combi

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-led integrated home service in people with Children With Medical Complexity (CMC) and Symptom Management, run by Dr Winsome Lam at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, 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: Time Frame: Day 0, Month 3, Month 6). 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?

On the ClinicalTrials.gov record for NCT07652268, which also lists 1 linked publication.

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 22 Sep 2026.

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