Clinical trial NCT05418569: Chinese Smartphone App for 6-18 Years With T1DM - RCT
Official title: The Impact of a Locally Tailored Evidence-based Chinese Smartphone Application in Management of Type 1 Diabetes Mellitus Aged 6-18 Years in Hong Kong - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 114
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Known type 1 DM diagnosed for at least 6 months
2. Aged 6-18 years
3. HbA1c \>/= 6.0% in the preceding 6 months prior to recruitment
4. Receiving DM care in Hong Kong

Exclusion Criteria:

1. Lack of the ability to use a smartphone application despite an introduction session the smartphone application intended for this study
2. Moderate to severe visual impairment that may affect the smartphone application usage
3. Cannot read Chinese language.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months (Assessed at 3 months and 6 months from start of intervention)
measure: CGM data
timeFrame: 6 months
measure: Self/Parent-reported questionnaires on hypoglycemia frequency
timeFrame: 6 months
Secondary outcomes:
measure: The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires
timeFrame: 6 months
measure: The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ)
timeFrame: 6 months
measure: The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module
timeFrame: 6 months
measure: Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study
timeFrame: 6 months
measure: Self-reported smartphone application usage satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Children's Hospital
Study officials:
affiliation: Hong Kong Children's Hospital
name: Samathan Lee
role: PRINCIPAL_INVESTIGATOR
References: