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

NCT05418569 | Unknown

• 1 other identifier: PR-HKCH-13
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• HbA1c

  A decrease of 0.5% is considered significant

  6 months (Assessed at 3 months and 6 months from start of intervention)

• CGM data

  Time in range, glycemic variability and percentage of hypoglycemia as documented by continuous glucose monitoring (for a period of 2 weeks) at baseline and at the end of study.

  6 months

• Self/Parent-reported questionnaires on hypoglycemia frequency

  Self/Parent-reported questionnaires on hypoglycemia frequency, the lowest glucose reading during hypoglycemia and number of severe hypoglycemia requiring glucagon use - to be performed at baseline and at the end of study.

  6 months

Secondary Outcomes (5)

• The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires

  6 months

• The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ)

  6 months

• The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module

  6 months

• Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study

  6 months

• Self-reported smartphone application usage satisfaction

  6 months

Study Arms (2)

Intervention Arm - Use of the new smartphone application for T1DM

ACTIVE COMPARATOR

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)

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

Control Arm - Standard diabetic education

PLACEBO COMPARATOR

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)

Other: Standard diabetic eduction

Interventions

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

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

Intervention Arm - Use of the new smartphone application for T1DM

Standard diabetic eduction OTHER

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

Control Arm - Standard diabetic education

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Samathan Lee

  Hong Kong Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samathan Lee

CONTACT

+852 5741 3307; llk051a@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Assistant Professor

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 14, 2022
• Study Start: July 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

HK (1)