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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04271631
Enrollment
105
Registered
2020-02-17
Start date
2019-06-12
Completion date
2020-05-31
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus, Mobile Application-Based Diabetes Education, Health Coaching

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.

Interventions

OTHERMobile Application-Based Diabetes Education

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

OTHERHealth Coaching

Health coaching was given as face to face with a coach

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

Open label

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Hb1A1c at 3 months3 monthsGlycemic control

Secondary

MeasureTime frameDescription
Change from Baseline 2 hours-post prandial plasma glucose at 3 months3 months after interventionGlycemic control
Change from Baseline Total cholesterol at 3 months3 months after interventionDiabetes Mellitus control
Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months3 months after interventionDiabetes Mellitus control
Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months3 months after interventionDiabetes Mellitus control
Change from Baseline Fasting plasma glucose at 3 months3 months after interventionGlycemic control
Mean of intake calories from food Recordat baseline, 3 months after interventionmean calorief from diet intake in 3 days
Global Physical Activities Questionnaireat baseline, 3 and 6 months after interventionQuestionnaire 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 Glucosethrough study completion, an average of 3 monthsNotes of daily blood glucose
Change from Baseline Triglycerides at 3 months3 months after interventionDiabetes Mellitus control

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026