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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Mobile Application-Based Diabetes Education
Health Coaching
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes mellitus, Mobile Application-Based Diabetes Education, Health Coaching

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Intervention 1

Intervention 2

Arm Description

Received conventional education group

Received conventional education group and Mobile Application-Based Diabetes Education

Received Mobile Application-Based Diabetes Education and Health Coaching

Outcomes

Primary Outcome Measures

Change from Baseline Hb1A1c at 3 months
Glycemic control

Secondary Outcome Measures

Change from Baseline Fasting plasma glucose at 3 months
Glycemic control
Change from Baseline 2 hours-post prandial plasma glucose at 3 months
Glycemic control
Change from Baseline Total cholesterol at 3 months
Diabetes Mellitus control
Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months
Diabetes Mellitus control
Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months
Diabetes Mellitus control
Change from Baseline Triglycerides at 3 months
Diabetes Mellitus control
Mean of intake calories from food Record
mean calorief from diet intake in 3 days
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.
Self-Monitoring Blood Glucose
Notes of daily blood glucose

Full Information

First Posted
February 7, 2020
Last Updated
February 12, 2020
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04271631
Brief Title
Integration of Education Based-Application and "CARE Coaching Model" in Management of Type 2 Diabetes Mellitus Patients Using Insulin
Official Title
Integrasi Edukasi Berbasis Aplikasi Dan "CARE Coaching Model" Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes mellitus, Mobile Application-Based Diabetes Education, Health Coaching

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Received conventional education group
Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
Received conventional education group and Mobile Application-Based Diabetes Education
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
Received Mobile Application-Based Diabetes Education and Health Coaching
Intervention Type
Other
Intervention Name(s)
Mobile Application-Based Diabetes Education
Other Intervention Name(s)
DM EduCorner Application
Intervention Description
Additional education was given using application, subjects were asked to open the application at least once a day
Intervention Type
Other
Intervention Name(s)
Health Coaching
Intervention Description
Health coaching was given as face to face with a coach
Primary Outcome Measure Information:
Title
Change from Baseline Hb1A1c at 3 months
Description
Glycemic control
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from Baseline Fasting plasma glucose at 3 months
Description
Glycemic control
Time Frame
3 months after intervention
Title
Change from Baseline 2 hours-post prandial plasma glucose at 3 months
Description
Glycemic control
Time Frame
3 months after intervention
Title
Change from Baseline Total cholesterol at 3 months
Description
Diabetes Mellitus control
Time Frame
3 months after intervention
Title
Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months
Description
Diabetes Mellitus control
Time Frame
3 months after intervention
Title
Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months
Description
Diabetes Mellitus control
Time Frame
3 months after intervention
Title
Change from Baseline Triglycerides at 3 months
Description
Diabetes Mellitus control
Time Frame
3 months after intervention
Title
Mean of intake calories from food Record
Description
mean calorief from diet intake in 3 days
Time Frame
at baseline, 3 months after intervention
Title
Global Physical Activities Questionnaire
Description
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.
Time Frame
at baseline, 3 and 6 months after intervention
Title
Self-Monitoring Blood Glucose
Description
Notes of daily blood glucose
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradana Soewondo, Prof
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Universitas Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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

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