NCT06903052

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress34%
May 2025Apr 2028

First Submitted

Initial submission to the registry

March 14, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

June 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

March 14, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

parental self-efficacychildren requiring mechanical ventilationsymptom managementmobile applicationnurse-led parental 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.

    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: 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

    month 9

Secondary Outcomes (2)

  • Modified Memorial Symptom Assessment Scale

    Day 0, Month 3, Month 6, Month 9

  • Children health service utilization

    Day 0, Month 3, Month 6, Month 9

Study Arms (1)

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.

Device: Nurse parental support using a proactive mobile App

Interventions

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

Nurse parental support using a proactive mobile App

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • a reported mental health disorder
  • engaging in other structured programs related to symptom management 3) 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

Kowloon, Kowloon, 852, Hong Kong

RECRUITING

Study Officials

  • Winsome LAM, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Winsome Lam, PhD

CONTACT

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 parental support using a proactive mobile App in symptom management for children requiring mechanical ventilation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 30, 2025

Study Start

May 6, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

June 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

IPD collected throughout the study, only IPD used in the results publication

Locations