跳至主要内容
临床试验/NCT05765643
NCT05765643招募中不适用

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

The Hong Kong Polytechnic University4 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
4
主要终点
Change of caregiver self-efficacy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change of caregiver self-efficacy

时间窗: 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.

次要结局

  • Change of children's symptom burden(0, week 12, week 24)
  • Change of children health service utilization(0, week 12, week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Winsome Lam

Assistant Professor

The Hong Kong Polytechnic University

研究点 (4)

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