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

February 12, 2020 updated by: Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Indonesia University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Pradana Soewondo, Prof, Fakultas Kedokteran Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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