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

August 7, 2025 updated by: Dr Winsome Lam, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
      • Kowloon, Hong Kong, 852
        • Completed
        • School of Nursing The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The eligible criteria for parents are:

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

Exclusion Criteria:

The exclusion criteria for parents are

  1. a reported mental health disorder
  2. engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse parental support in symptom management using a mobile health App over 3 months
Other: Nurse parental support in symptom management using a mobile health App
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
No Intervention: Wait-listed control
Parents in this group can join the usual community social or health care services as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, week 12, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, week 12, week 24
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).
0, week 12, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Research Grants Council, Hong Kong

Investigators

  • Principal Investigator: Lam Winsome, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Actual)

December 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20220721005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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