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Development of Diabetes Mobile Application

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ClinicalTrials.gov Identifier: NCT04686201
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
National University of Malaysia

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Diabetes Mobile Application Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group Device: Diabetes Mobile Application
incorporating mobile application usage in managing diabetes mellitus patient in health clinics

No Intervention: control group



Primary Outcome Measures :
  1. Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application [ Time Frame: 6 months ]
    Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application (assessment using Michigan Diabetes Knowledge Test Questionnaire)

  2. Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application [ Time Frame: 6 months ]
    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)

  3. Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes after using Diabetes Mobile Application [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686201


Contacts
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Contact: MOHD ROHAIZAT HASSAN, PhD +60126343303 rohaizat@ppukm.ukm.edu.my
Contact: MOHD NAZRIN JAMHARI, MPH +60173287707 drmohdnazrin@gmail.com

Locations
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Malaysia
Jabatan Kesihatan Negeri Kedah Recruiting
Alor Setar, Kedah, Malaysia, 05400
Contact: MOHD NAZRIN JAMHARI, MPH    0173287707    drmohdnazrin@gmail.com   
Sponsors and Collaborators
National University of Malaysia
Investigators
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Principal Investigator: MOHD ROHAIZAT HASSAN, PhD Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia
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Responsible Party: National University of Malaysia
ClinicalTrials.gov Identifier: NCT04686201    
Other Study ID Numbers: Diabetes Apps
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases