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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Mobile Application-Based Diabetes Education; Other: Health Coaching

• Registration Number: NCT04271631
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-06-12
• Primary Completion: 2020-01-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 1	Mobile Application-Based Diabetes Education	Received conventional education group and Mobile Application-Based Diabetes Education
Intervention 2	Mobile Application-Based Diabetes Education	Received Mobile Application-Based Diabetes Education and Health Coaching
Intervention 2	Health Coaching	Received Mobile Application-Based Diabetes Education and Health Coaching

Primary Outcome Measures

Name	Time	Method
Change from Baseline Hb1A1c at 3 months	3 months	Glycemic control

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Total cholesterol at 3 months	3 months after intervention	Diabetes Mellitus control
Self-Monitoring Blood Glucose	through study completion, an average of 3 months	Notes of daily blood glucose
Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months	3 months after intervention	Diabetes Mellitus control
Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months	3 months after intervention	Diabetes Mellitus control
Change from Baseline Triglycerides at 3 months	3 months after intervention	Diabetes Mellitus control
Change from Baseline Fasting plasma glucose at 3 months	3 months after intervention	Glycemic control
Change from Baseline 2 hours-post prandial plasma glucose at 3 months	3 months after intervention	Glycemic control
Mean of intake calories from food Record	at baseline, 3 months after intervention	mean calorief from diet intake in 3 days
Global Physical Activities Questionnaire	at baseline, 3 and 6 months after intervention	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.

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia