Nurse Parental Support Using a Mobile App in Symptom Management for CMC
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
1 other identifier
interventional
96
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
Typical duration for not_applicable
2 active sites
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
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
August 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 8, 2025
June 1, 2025
1.4 years
February 28, 2023
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of caregiver self-efficacy
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 Outcomes (2)
Change of children health service utilization
0, week 12, week 24
Change of children's symptom burden
0, week 12, week 24
Study Arms (2)
Nurse parental support in symptom management using a mobile health App over 3 months
EXPERIMENTALWait-listed control
NO INTERVENTIONParents in this group can join the usual community social or health care services as usual.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
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 (2)
School of Nursing The Hong Kong Polytechnic University
Kowloon, Kowloon, 852, Hong Kong
School of Nursing
Hong Kong, 852, Hong Kong
Related Publications (1)
Lam W, Zhao Z, Law QP, Ngai VW, Wong FK, Fowler C. Nurse-led proactive mobile application in symptom management for children with medical complexity: Study protocol for a randomized controlled trial. J Adv Nurs. 2024 Sep;80(9):3856-3865. doi: 10.1111/jan.16294.
PMID: 39118424DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lam Winsome, PhD
The Hong Kong Polytechnic University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 13, 2023
Study Start
August 15, 2023
Primary Completion
December 30, 2024
Study Completion
December 31, 2025
Last Updated
August 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share