Development of Diabetes Mobile Application

NCT ID: NCT04686201

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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intervention group

Group Type EXPERIMENTAL

Diabetes Mobile Application

Intervention Type DEVICE

incorporating mobile application usage in managing diabetes mellitus patient in health clinics

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diabetes Mobile Application

incorporating mobile application usage in managing diabetes mellitus patient in health clinics

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MOHD ROHAIZAT HASSAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia

Locations

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Jabatan Kesihatan Negeri Kedah

Alor Star, Kedah, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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MOHD ROHAIZAT HASSAN, PhD

Role: CONTACT

Phone: +60126343303

Email: [email protected]

MOHD NAZRIN JAMHARI, MPH

Role: CONTACT

Phone: +60173287707

Email: [email protected]

Facility Contacts

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MOHD NAZRIN JAMHARI, MPH

Role: primary

Other Identifiers

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Diabetes Apps

Identifier Type: -

Identifier Source: org_study_id