NCT04686201

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2019

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

December 20, 2020

Last Update Submit

December 24, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

intervention group

EXPERIMENTAL
Device: Diabetes Mobile Application

control group

NO INTERVENTION

Interventions

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

intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jabatan Kesihatan Negeri Kedah

Alor Star, Kedah, 05400, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • MOHD ROHAIZAT HASSAN, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MOHD ROHAIZAT HASSAN, PhD

CONTACT

MOHD NAZRIN JAMHARI, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 28, 2020

Study Start

August 1, 2019

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12

Locations