Nurse Parental Support Using a Mobile App in Symptom Management for CMC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse parental support in symptom management using a mobile health App.
- Who it may be relevant to
- Registry conditions: Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy, Child With Medical Complexity. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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
Primary outcome measures
- Change of caregiver self-efficacy [Time frame: 0, week 12, week 24]
Secondary outcome measures (2)
- Change of children health service utilization [Time frame: 0, week 12, week 24]
- Change of children's symptom burden [Time frame: 0, week 12, week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Hong Kong · 2 centers
- School of Nursing The Hong Kong Polytechnic University — Kowloon
- School of Nursing — Hong Kong
Publications
- 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 39118424
Identifiers
NCT: NCT05765643 · HSEARS20220721005