Nurse Parental Support Using a Mobile App in Symptom Management for CMC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorThe Hong Kong Polytechnic University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
a reported mental health disorder
engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse parental support in symptom management using a mobile health App
Other interventionParents 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
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Nurse parental support in symptom management using a mobile health App over 3 monthsExperimental treatment 1 intervention
Group B: Wait-listed controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change of caregiver self-efficacy
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.
Time frame
0, week 12, week 24Secondary outcomes
1
Change of children health service utilization
This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.
Time frame
0, week 12, week 242
Change of children's symptom burden
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).
Time frame
0, week 12, week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
Research Grants Council, Hong Kong
Collaborator
Source ClinicalTrials.gov