Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05418569 |
Other study ID # |
PR-HKCH-13 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
June 1, 2024 |
Study information
Verified date |
June 2022 |
Source |
Chinese University of Hong Kong |
Contact |
Samathan Lee |
Phone |
+852 5741 3307 |
Email |
llk051a[@]ha.org.hk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Moving into the era of electronic communication, it changes the way we shall engage our
children and adolescents. According to data of the Census and Statistics Department of Hong
Kong releases in 2019, more than 80% and up to 99.4% of those aged 10-14 years, and aged
15-24 years respectively had a mobile phone device. A recent survey carried by Kebede et al.
(2019) had shown that using diabetes apps was positively associated with self-care behavior
in type 1 and type 2 diabetes mellitus (DM). A systematic review carried in Spain by Quevedo
Rodríguez et al. (2018) had found most of the available smartphone apps lacked quality
certification and very few provide scientific references on their content.
In Hong Kong, there is currently no Chinese smartphone application targeting for the
pediatric type 1 population, therefore, most of the education is based on face-to-face or
telephone communication with the diabetic nurse and endocrinologists in limited encounters.
For families or patients with limited command of English language, apart from one adult
oriented DM information smartphone application, the chance of having on-hand mobile device
support is truly limited. In light of this context, we shall first design an evidence-based
locally tailored Chinese smartphone application for pediatric type 1 DM and then evaluate its
effectiveness in improving management of type 1 DM in a robust manner.
The main research question for this project is whether a self-help smartphone application in
local Chinese language, tailored to include local clinical practice, culture and food
spectrum, can improve diabetes control and psychological wellbeing in patients with type 1
diabetes mellitus aged 6-18 years. Eligible participants will be randomized to either using
the smartphone application (on top of standard diabetic care) or continue standard diabetic
care. The study aims to compare the difference between the two groups for their diabetic
control and the psychological wellbeing.
Description:
Objectives To evaluate the impact of a locally designed evidence-based Chinese smartphone
application in improving type 1 diabetes mellitus management for aged 6-18 years in Hong
Kong.
Hypothesis Use of smartphone application can improve diabetes mellitus control and self-care
ability, psychological wellbeing and quality of life.
Design and subjects A single-blinded randomized controlled trial employing block
randomization. Inclusion criteria: (1) Type 1 diabetes mellitus diagnosed for at least 6
months, (2) Aged 6-18 years, (3) HbA1c >/=6.0%, (4) Receiving DM care in Hong Kong. Exclusion
criteria: (1) Lack of the ability to use a smartphone application, (2) Moderate to severe
visual impairment, (3) Cannot read Chinese language. Aim for 57 participants in each of the
control and intervention arms for a statistical power of 80%.
Study instruments
(1) HemoglobinA1c, (2) Time in range and frequency of hypoglycaemia by continuous glucose
monitoring, (3) Chinese versions of PSC-35, PedsQL and DSMQ questionnaires.
Interventions Use of the smartphone application for 6 months.
Main outcome measures Primary outcomes include (1) HbA1c, (2) Time in range, (2) Frequency of
hypoglycaemia. Secondary outcomes are scores of PSC-35, PedsQL and DSMQ.
Data analysis and expected results Data to be analysed with intention-to-treat. A post hoc
analysis is planned to capture data in the reduced application usage group. Generalized
estimating equation will be employed to analyse the data involving within-subject covariance.
Around 10% dropout rate assumed. A statistically significant result is defined by a 2-tailed
alpha level of 0.05.