Nurse Parental Support Using a Mobile App to Enhance Parental Self-efficacy in Symptom Management for the Children With Medical Complexity: A Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
Parents of children with medical complexity (CMC) are at risk of high stress levels because these CMC have multisystem diseases, including severe neurologic conditions or cancer, resulting in potential premature death. These children experience one or more physical and psychological symptoms simultaneously that can seriously affect their quality of life and increase use of health services. Parents may feel challenged, lacking 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 the child's health. Home-based nursing services for the CMC and parents are available in Hong Kong, but 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 application is an alternative method considered more accessible and nurse-parent interactivity to continue home-based support for the CMC and parents. This proposed randomized controlled trial will test the effects of a mobile App with nurse support for enhancing parental self-efficacy in symptom management for CMC in communities. 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 parental support in symptom management using a proactive mobile application, and the wait-listed control group receiving usual community care for 120 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 (parental self-efficacy) at three-month after intervention across the two study groups using ANCOVA with control for the pre-test value of parental self-efficacy (primary objective). 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 (parental self-efficacy, children's symptom burden, and health service utilization) 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.

Official Title
-----------------
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 Children With Medical Complexity in Communities: A Randomized Control Trial

Conditions
-----------------
Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy, Child With Medical Complexity

Intervention / Treatment
-----------------
* Other: Nurse parental support in symptom management using a mobile health App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-blinded, randomized controlled trial with two-armed repeated measures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse parental support in symptom management using a mobile health App over 3 months<br> | Other: Nurse parental support in symptom management using a mobile health App<br>* Parents 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<br>|
| No Intervention: Wait-listed control<br>Parents in this group can join the usual community social or health care services as usual. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, week 12, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, week 12, week 24 | 
| 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). | 0, week 12, week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child with medical complexity, Child with cancer, parental self-efficacy, mobile health application, symptom management