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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05765643
Collaborator
(none)
120
2
9.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nurse parental support in symptom management using a mobile health App
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a single-blinded, randomized controlled trial with two-armed repeated measuresThis is a single-blinded, randomized controlled trial with two-armed repeated measures
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nurse parental support in symptom management using a mobile health App over 3 months

Other: Nurse parental support in symptom management using a mobile health App
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

No Intervention: Wait-listed control

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

Outcome Measures

Primary Outcome Measures

  1. Change of caregiver self-efficacy [0, 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

  1. Change of children health service utilization [0, 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.

  2. Change of children's symptom burden [0, 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Winsome Lam, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05765643
Other Study ID Numbers:
  • HSEARS20220721005
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Winsome Lam, Assistant Professor, The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2023