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

Not Applicable
Recruiting
Conditions
Child With Medical Complexity
Muscular Atrophy
Child With Cancer
Child With Cerebral Palsy
Interventions
Other: Nurse parental support in symptom management using a mobile health App
Registration Number
NCT05765643
Lead Sponsor
The Hong Kong Polytechnic University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Nurse parental support in symptom management using a mobile health App over 3 monthsNurse parental support in symptom management using a mobile health App-
Primary Outcome Measures
NameTimeMethod
Change of caregiver self-efficacy0, 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.

Secondary Outcome Measures
NameTimeMethod
Change of children's symptom burden0, week 12, week 24

This is a modified 40-item Memorial Symptom Assessment Scale (MSAS in Chinese version). The items for measuring the frequency and severity of symptoms are rated on a 4-point Likert scale from one (almost never) to four (always). The items for measuring distress are rated on a 5-point Likert scale from one (not at all) to five (very).

Change of children health service utilization0, week 12, week 24

This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.

Trial Locations

Locations (1)

School of Nursing

🇭🇰

Hong Kong, Hong Kong

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