NCT07652268

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Children requiring respiratory support

Outcome Measures

Primary Outcomes (2)

  • 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.

    Time Frame: Day 0, Month 3, Month 6

  • 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

    Time Frame: month 6

Secondary Outcomes (3)

  • Modified Memorial Symptom Assessment Scale

    Time Frame: Day 0, Month 3, Month 6

  • Children health service utilization

    Time Frame: Day 0, Month 3, Month 6

  • Depression Anxiety Stress Scale (DASS) (Chinese version)

    Time Frame: Day 0, Month 3, Month 6

Study Arms (1)

Nurse-led integrated home service

EXPERIMENTAL

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

Other: Nurse-led integrated home service

Interventions

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

Nurse-led integrated home service

Eligibility Criteria

Age6 Months - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing The Hong Kong Polytechnic University

Hong Kong, 852, China

Location

Related Publications (1)

  • 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

    RESULT

Central Study Contacts

Winsome Lam, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Nurse-led integrated home health service to support parents in Symptom Management for Children With Respiratory Support
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 17, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Privacy

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