Clinical trial NCT04271631: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus
Mobile Application-Based Diabetes Education
Health Coaching
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change from Baseline Hb1A1c at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from Baseline Fasting plasma glucose at 3 months
timeFrame: 3 months after intervention
measure: Change from Baseline 2 hours-post prandial plasma glucose at 3 months
timeFrame: 3 months after intervention
measure: Change from Baseline Total cholesterol at 3 months
timeFrame: 3 months after intervention
measure: Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months
timeFrame: 3 months after intervention
measure: Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months
timeFrame: 3 months after intervention
measure: Change from Baseline Triglycerides at 3 months
timeFrame: 3 months after intervention
measure: Mean of intake calories from food Record
timeFrame: at baseline, 3 months after intervention
measure: Global Physical Activities Questionnaire
timeFrame: at baseline, 3 and 6 months after intervention
measure: Self-Monitoring Blood Glucose
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Pradana Soewondo, Prof
role: PRINCIPAL_INVESTIGATOR
References: