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NCT Number: NCT07652268

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

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.

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Key information

Age range

6 month–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing The Hong Kong Polytechnic University

Hong Kong, 852, China

Location contact

winsome Yorke, PhD

CONTACT

[email protected]

852-2766 ext. 4291

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Nurse-led integrated home service

Other

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

Primary outcomes

  1. Caregiving Self-efficacy

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

    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: Time Frame: month 6

    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-led integrated home service

Secondary outcomes

  1. Modified Memorial Symptom Assessment Scale

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

    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.

  2. Children health service utilization

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

    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

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

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

    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.

Study contacts

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

Winsome Lam, PhD

CONTACT

[email protected]

852-2766 ext. 4291

Sponsors and collaborators

Lead sponsor

Dr Winsome Lam

Other

Registry information

Official study title

Nurse-led Integrated Home Health Service to Support Parents in Symptom Management for Children With Respiratory Support: an Effectiveness-implementation Hybrid 2 Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2026
Registry last updated
Jun 18, 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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