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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

Primary Purpose

Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nurse parental support in symptom management using a mobile health App
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Child With Cancer focused on measuring Child with medical complexity, Child with cancer, parental self-efficacy, mobile health application, symptom management

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Nurse parental support in symptom management using a mobile health App over 3 months

    Wait-listed control

    Arm Description

    Parents in this group can join the usual community social or health care services as usual.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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).

    Full Information

    First Posted
    February 28, 2023
    Last Updated
    March 9, 2023
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05765643
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy, Child With Medical Complexity
    Keywords
    Child with medical complexity, Child with cancer, parental self-efficacy, mobile health application, symptom management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a single-blinded, randomized controlled trial with two-armed repeated measures
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nurse parental support in symptom management using a mobile health App over 3 months
    Arm Type
    Experimental
    Arm Title
    Wait-listed control
    Arm Type
    No Intervention
    Arm Description
    Parents in this group can join the usual community social or health care services as usual.
    Intervention Type
    Other
    Intervention Name(s)
    Nurse parental support in symptom management using a mobile health App
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change of caregiver self-efficacy
    Description
    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 24
    Secondary Outcome Measure Information:
    Title
    Change of children health service utilization
    Description
    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 24
    Title
    Change of children's symptom burden
    Description
    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 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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