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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271631
Recruitment Status : Active, not recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Mobile Application-Based Diabetes Education Other: Health Coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Other
Official Title: Integrasi Edukasi Berbasis Aplikasi Dan "CARE Coaching Model" Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin
Actual Study Start Date : June 12, 2019
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Received conventional education group
Experimental: Intervention 1
Received conventional education group and Mobile Application-Based Diabetes Education
Other: Mobile Application-Based Diabetes Education
Additional education was given using application, subjects were asked to open the application at least once a day
Other Name: DM EduCorner Application

Experimental: Intervention 2
Received Mobile Application-Based Diabetes Education and Health Coaching
Other: Mobile Application-Based Diabetes Education
Additional education was given using application, subjects were asked to open the application at least once a day
Other Name: DM EduCorner Application

Other: Health Coaching
Health coaching was given as face to face with a coach




Primary Outcome Measures :
  1. Change from Baseline Hb1A1c at 3 months [ Time Frame: 3 months ]
    Glycemic control


Secondary Outcome Measures :
  1. Change from Baseline Fasting plasma glucose at 3 months [ Time Frame: 3 months after intervention ]
    Glycemic control

  2. Change from Baseline 2 hours-post prandial plasma glucose at 3 months [ Time Frame: 3 months after intervention ]
    Glycemic control

  3. Change from Baseline Total cholesterol at 3 months [ Time Frame: 3 months after intervention ]
    Diabetes Mellitus control

  4. Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months [ Time Frame: 3 months after intervention ]
    Diabetes Mellitus control

  5. Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months [ Time Frame: 3 months after intervention ]
    Diabetes Mellitus control

  6. Change from Baseline Triglycerides at 3 months [ Time Frame: 3 months after intervention ]
    Diabetes Mellitus control

  7. Mean of intake calories from food Record [ Time Frame: at baseline, 3 months after intervention ]
    mean calorief from diet intake in 3 days

  8. Global Physical Activities Questionnaire [ Time Frame: at baseline, 3 and 6 months after intervention ]
    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.

  9. Self-Monitoring Blood Glucose [ Time Frame: through study completion, an average of 3 months ]
    Notes of daily blood glucose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271631


Locations
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Indonesia
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Pradana Soewondo, Prof Fakultas Kedokteran Universitas Indonesia

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Responsible Party: Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Professor, Endocrinologist, Indonesia University
ClinicalTrials.gov Identifier: NCT04271631    
Other Study ID Numbers: PS001
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Indonesia University:
Type 2 diabetes mellitus
Mobile Application-Based Diabetes Education
Health Coaching
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases