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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Dec 31, 2025 to May 31, 2025
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date changed from estimate of Jun 30, 2025 to Dec 30, 2024
    • Site details revised at 1 of 2 sites
    v6
  3. Enrollment target: 120 to 96
    • Study sites: 1 to 2
    v5
  4. Primary completion date: Sep 30, 2024 to Jun 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v4
  5. Study title shortened, about 2 wordsv3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jun 30, 2023 to Sep 30, 2024
    • Start date changed from estimate of Mar 15, 2023 to Aug 15, 2023
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Study title shortened, about 10 words
    • Collaborators expanded, about 5 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05765643
Lead Sponsor The Hong Kong Polytechnic University
Collaborators: Research Grants Council, Hong Kong
Conditions
(from sponsor)		 Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy, Child With Medical Complexity
Related terms Muscular Atrophy
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov