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Development of Diabetes Mobile Application

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Diabetes Mobile Application
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jabatan Kesihatan Negeri KedahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2020
Last Updated
December 24, 2020
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04686201
Brief Title
Development of Diabetes Mobile Application
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
Specific Objective To develop and validate a diabetes mobile-app (MyD-App) for patients with uncontrolled Type 2 Diabetes Mellitus. 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 There is an increased in patient's knowledge on diabetes after MyD-App usage. There is an increased in patient's compliance on medication and treatment after MyD-App usage. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Diabetes Mobile Application
Intervention Description
incorporating mobile application usage in managing diabetes mellitus patient in health clinics
Primary Outcome Measure Information:
Title
Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application
Description
Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application (assessment using Michigan Diabetes Knowledge Test Questionnaire)
Time Frame
6 months
Title
Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application
Description
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)
Time Frame
6 months
Title
Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes after using Diabetes Mobile Application
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOHD ROHAIZAT HASSAN, PhD
Phone
+60126343303
Email
rohaizat@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
MOHD NAZRIN JAMHARI, MPH
Phone
+60173287707
Email
drmohdnazrin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOHD ROHAIZAT HASSAN, PhD
Organizational Affiliation
Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jabatan Kesihatan Negeri Kedah
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOHD NAZRIN JAMHARI, MPH
Phone
0173287707
Email
drmohdnazrin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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