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Clinical Trials/NCT04271631
NCT04271631
Unknown
Not Applicable

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

Indonesia University1 site in 1 country105 target enrollmentJune 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Indonesia University
Enrollment
105
Locations
1
Primary Endpoint
Change from Baseline Hb1A1c at 3 months
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2019
End Date
May 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Professor, Endocrinologist

Indonesia University

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

Outcomes

Primary Outcomes

Change from Baseline Hb1A1c at 3 months

Time Frame: 3 months

Glycemic control

Secondary Outcomes

  • Change from Baseline Total cholesterol at 3 months(3 months after intervention)
  • Self-Monitoring Blood Glucose(through study completion, an average of 3 months)
  • Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months(3 months after intervention)
  • Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months(3 months after intervention)
  • Change from Baseline Triglycerides at 3 months(3 months after intervention)
  • Change from Baseline Fasting plasma glucose at 3 months(3 months after intervention)
  • Change from Baseline 2 hours-post prandial plasma glucose at 3 months(3 months after intervention)
  • Mean of intake calories from food Record(at baseline, 3 months after intervention)
  • Global Physical Activities Questionnaire(at baseline, 3 and 6 months after intervention)

Study Sites (1)

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