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

NCT ID: NCT04271631

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2020-05-31

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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open label

Study Groups

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Control

Received conventional education group

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention 1

Received conventional education group and Mobile Application-Based Diabetes Education

Group Type EXPERIMENTAL

Mobile Application-Based Diabetes Education

Intervention Type OTHER

Additional education was given using application, subjects were asked to open the application at least once a day

Intervention 2

Received Mobile Application-Based Diabetes Education and Health Coaching

Group Type EXPERIMENTAL

Mobile Application-Based Diabetes Education

Intervention Type OTHER

Additional education was given using application, subjects were asked to open the application at least once a day

Health Coaching

Intervention Type OTHER

Health coaching was given as face to face with a coach

Interventions

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Mobile Application-Based Diabetes Education

Additional education was given using application, subjects were asked to open the application at least once a day

Intervention Type OTHER

Health Coaching

Health coaching was given as face to face with a coach

Intervention Type OTHER

Other Intervention Names

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DM EduCorner Application

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD

Professor, Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pradana Soewondo, Prof

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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PS001

Identifier Type: -

Identifier Source: org_study_id

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