Integration of Education Based-Application and CARE Coaching Model in Management of Type 2 Diabetes Mellitus Patients Using Insulin

Study Overview
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Brief Summary
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Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.

Detailed Description
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A randomized control trial, pre and post study involving 105 subjects randomized into 3 arms: Control : received conventional education group Intervention 1 : received conventional education group + mobile application-based diabetes education Intervention 2 : received mobile application-based diabetes education + health coaching Conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes. Mobile application-based diabetes education is using DM Educorner (Diabetes Mellitus Education Corner) availablle in Google PlayStore. Education contents was delivered in articles, video and infographics. Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach. Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Official Title
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Integrasi Edukasi Berbasis Aplikasi Dan CARE Coaching Model Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Mobile Application-Based Diabetes Education
* Other: Health Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes Mellitus multiple daily insulin injection (basal and rapid, or mixed) 30 - 65 years old HbA1c > 8% Using smartphone in daily lives. Willing to follow the research by signing an informed consent Exclusion Criteria: Patients with cognitive disease (such as dementia) Patients with hearing or sight problem Unable to live independently on daily basis Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Received conventional education group | |
| Experimental: Intervention 1<br>Received conventional education group and Mobile Application-Based Diabetes Education | Other: Mobile Application-Based Diabetes Education<br>* Additional education was given using application, subjects were asked to open the application at least once a day<br>* Other names: DM EduCorner Application;|
| Experimental: Intervention 2<br>Received Mobile Application-Based Diabetes Education and Health Coaching | Other: Mobile Application-Based Diabetes Education<br>* Additional education was given using application, subjects were asked to open the application at least once a day<br>* Other names: DM EduCorner Application;Other: Health Coaching<br>* Health coaching was given as face to face with a coach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Hb1A1c at 3 months | Glycemic control | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Fasting plasma glucose at 3 months | Glycemic control | 3 months after intervention | 
| Change from Baseline 2 hours-post prandial plasma glucose at 3 months | Glycemic control | 3 months after intervention | 
| Change from Baseline Total cholesterol at 3 months | Diabetes Mellitus control | 3 months after intervention | 
| Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months | Diabetes Mellitus control | 3 months after intervention | 
| Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months | Diabetes Mellitus control | 3 months after intervention | 
| Change from Baseline Triglycerides at 3 months | Diabetes Mellitus control | 3 months after intervention | 
| Mean of intake calories from food Record | mean calorief from diet intake in 3 days | at baseline, 3 months after intervention | 
| Global Physical Activities Questionnaire | Questionnaire about physical activities in whole one week. Divided into 3 categories: low, moderate, high. Every categories describe duration and numbers of day being active during 1 weeks and not for judging it is good or worse. | at baseline, 3 and 6 months after intervention | 
| Self-Monitoring Blood Glucose | Notes of daily blood glucose | through study completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Mobile Application-Based Diabetes Education, Health Coaching