Development of Diabetes Mobile Application

Development of Diabetes Mobile Application "MyD App" To Improve Patient's Knowledge, Compliance and Control: An Interventional Study Among Uncontrolled Type 2 Diabetes Mellitus Patients in Kedah, Malaysia

this study is to measure the effectiveness of a diabetes mobile application for improving patient's knowledge, compliance and diabetes control among uncontrolled Type 2 Diabetes Mellitus mellitus patients in Kedah

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Diabetes Mobile Application

Detailed Description

Specific Objective

1. To develop and validate a diabetes mobile-app (MyD-App) for patients with uncontrolled Type 2 Diabetes Mellitus.
2. To measure the effectiveness of a diabetes mobile application for improving knowledge, compliance and control using the newly developed and validated MyD-App among patients with uncontrolled Type 2 Diabetes Mellitus.

Hypothesis

1. There is an increased in patient's knowledge on diabetes after MyD-App usage.
2. There is an increased in patient's compliance on medication and treatment after MyD-App usage.
3. There is a diabetes control improvement (HbA1C < 6.5% or HbA1C reduction ≥ 1%) among Type 2 Diabetes Mellitus patients in Kedah after MyD-App usage.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Kedah
    • Alor Setar, Kedah, Malaysia, 05400
      • Recruiting
      • Jabatan Kesihatan Negeri Kedah
      • Contact: MOHD NAZRIN JAMHARI, MPH; Phone Number: 0173287707; Email: drmohdnazrin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-80 years old
• Diagnosed with type 2 diabetes mellitus by a registered medical doctor.
• Registered and actively follow up in the health clinics at selected districts. (actively follow up: follow up at the clinic for at least once in a year).
• Own a smartphone with the Android platform.
• HbA1C >7%

Exclusion Criteria:

• GDM
• Illiterate
• Anemia / Thalassemia
• Not agree to be the sample for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: intervention group	Device: Diabetes Mobile Application; incorporating mobile application usage in managing diabetes mellitus patient in health clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application	Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application (assessment using Michigan Diabetes Knowledge Test Questionnaire)	6 months
Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application	Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application (assessment using Malaysia Medication Adherence Assessment Tool (MyMAAT) for diabetic patients)	6 months
Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes after using Diabetes Mobile Application	Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes (HbA1C 7% or more than 1% reduction of HbA1C) after using Diabetes Mobile Application	6 months

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: MOHD ROHAIZAT HASSAN, PhD, Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Diabetes Apps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No