NCT05765643 Nurse Parental Support Using a Mobile App in Symptom Management for CMC
| NCT ID | NCT05765643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Child With Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2023-08-15 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Lam Winsome, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT05765643 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Child With Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05765643 currently recruiting?
Yes, NCT05765643 is actively recruiting participants. Contact the research team at winsome.lam@polyu.edu.hk for enrollment information.
Where is the NCT05765643 trial being conducted?
This trial is being conducted at Kowloon, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT05765643 clinical trial?
NCT05765643 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Lam Winsome, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 96 participants.
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