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NCT Number: NCT05765643

Nurse Parental Support Using a Mobile App in Symptom Management for CMC

Parents of children with medical complexity (CMC) are suffering from high level of stress. These CMC get multisystem diseases, including severe neurologic conditions or cancer, resulting in potential premature death. They experience one or more physical and psychological symptoms at one time, which seriously affect their quality of life and increase their health services utilization. Parents may lack confidence in their abilities when managing their child's symptoms. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve child's health status. Home-based nursing services for the CMC and parents are available in Hong Kong. However, the service faces challenges because of serious nursing workforce shortage and the recent coronavirus pandemic. Nurse parental support in symptom management using a proactive mobile health App is an alternative method considered more feasible to continue home-based support for the CMC and parents.

This proposed RCT will test the effects of a nurse-led mobile App for enhancing parental self-efficacy in symptom management for CMC. A repeated-measures, two-group design will be used to evaluate the effects between intervention and wait-listed control groups by comparing the study group receiving nurse support using a mobile App, and the wait-listed control group receiving usual community care for 96 randomly selected parents over a three-month follow-up. Primary outcome is parental self-efficacy. Secondary outcomes include children's symptom burden and health services utilization. These factors will be measured before intervention, immediately after intervention and three-month after intervention. The effectiveness of the intervention will be evaluated by comparing the primary outcome at three-month after intervention across the two study groups using ANCOVA with control for the pre-test value of parental self-efficacy. Generalized estimating equation will be used to address secondary objectives regarding the effectiveness of the mobile App as compared to the control on secondary outcomes from T1 to T3 with appropriate link function. It is hypothesized that nurse support using the mobile App is more effective than usual community care in enhancing parental self-efficacy in symptom management for their CMC at three-month after intervention.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing The Hong Kong Polytechnic University, Kowloon, Hong Kong

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The eligible criteria for parents are:

  • parent of a child with medical complexity aged 2-18
  • having a Smartphone
  • able to communicate in Chinese and read Chinese
  • living with his/her child at home.

Exclusion criteria

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.

Treatment and study plan

Nurse parental support in symptom management using a mobile health App

Other

Parents in this group will receive a mobile App that includes health assessment, monitoring, health education and nurse support using phone calls over a 3-month period

Primary outcomes

  1. Change of caregiver self-efficacy

    Time frame: 0, week 12, week 24

    The CaSES (Chinese version) is a 18-item scale. It is rated on a 9-point scale, with 1= no confidence, to 9 =full confidence.

Secondary outcomes

  1. Change of children health service utilization

    Time frame: 0, week 12, week 24

    This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.

  2. Change of children's symptom burden

    Time frame: 0, week 12, week 24

    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).

Study contacts

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

Lam Winsome, PhD

CONTACT

[email protected]

27664291

Sze Wan Man

CONTACT

[email protected]

27664291

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Research Grants Council, Hong Kong

Registry information

Official study title

Is Nurse Parental Support Using a Proactive Mobile Health Application More Effective Than Usual Community Care in Enhancing Parental Self-efficacy in Symptom Management for the CMC in Communities: A RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 13, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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