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临床试验/NCT04686201
NCT04686201Unknown3 期

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

National University of Malaysia2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
80
试验地点
2
主要终点
Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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%

排除标准

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

结局指标

主要结局

Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application

时间窗: 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)

Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application

时间窗: 6 months

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 control diabetes after using Diabetes Mobile Application

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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