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Trial Title:
Nurse Parental Support Using a Mobile App in Symptom Management for CMC
NCT ID:
NCT05765643
Condition:
Child With Cancer
Muscular Atrophy
Child With Cerebral Palsy
Child With Medical Complexity
Conditions: Official terms:
Cerebral Palsy
Muscular Atrophy
Conditions: Keywords:
Child with medical complexity
Child with cancer
parental self-efficacy
mobile health application
symptom management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a single-blinded, randomized controlled trial with two-armed repeated measures
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Nurse parental support in symptom management using a mobile health App
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
Arm group label:
Nurse parental support in symptom management using a mobile health App over 3 months
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
2 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
School of Nursing
Address:
City:
Hong Kong
Zip:
852
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Winsome LAM, PhD
Phone:
8522766
Phone ext:
4291
Email:
winsome.lam@polyu.edu.hk
Start date:
August 15, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
The Hong Kong Polytechnic University
Agency class:
Other
Collaborator:
Agency:
Research Grants Council, Hong Kong
Agency class:
Other
Source:
The Hong Kong Polytechnic University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765643
