Chinese Smartphone App for 6-18 Years With T1DM - RCT

NCT ID: NCT05418569

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-06-01

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.

Conditions

Type1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention Arm - Use of the new smartphone application for T1DM

The use of the locally designed smartphone application for T1DM for 6 months, which contained the following domains:

• Type 1 DM self-management information and decision-making algorithm
• Carbohydrate counting information on local food in Hong Kong
• DM day-to-day troubleshooting psychosocial scenarios
• Game-based interactive tools for DM knowledge enhancement
• Usage tracking for each domain of the smartphone application
• Individual participant identification and access code (known to research assistant)

Group Type: ACTIVE_COMPARATOR

Intervention arm - A new smartphone application for pediatric type 1 DM

Intervention Type: DEVICE

An evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM

Control Arm - Standard diabetic education

Received standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic information for both adult and pediatric population (that encompasses both information for type 1 and type 2 DM)

Group Type: PLACEBO_COMPARATOR

Standard diabetic eduction

Intervention Type: OTHER

Received standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic

Interventions

Intervention arm - A new smartphone application for pediatric type 1 DM

An evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM

Intervention Type: DEVICE

Standard diabetic eduction

Received standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

LEE LAI KA SAMANTHA

Honorary Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samathan Lee

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Children's Hospital

Locations

Hong Kong Children's Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Samathan Lee

Role: CONTACT

llk051a@ha.org.hk

+852 5741 3307

Facility Contacts

Samantha Lee

Role: primary

llk051a@ha.org.hk

+852 5741 3307

Other Identifiers

PR-HKCH-13

Identifier Type: -

Identifier Source: org_study_id