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

Sponsor
Indonesia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04271631
Collaborator
(none)
105
Enrollment
1
Location
3
Arms
11.6
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Mobile Application-Based Diabetes Education
  • Other: Health Coaching
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Jun 12, 2019
Actual Primary Completion Date :
Jan 31, 2020
Anticipated Study Completion Date :
May 31, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • DM EduCorner Application

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Hb1A1c at 3 months [3 months]

      Glycemic control

    Secondary Outcome Measures

    1. Change from Baseline Fasting plasma glucose at 3 months [3 months after intervention]

      Glycemic control

    2. Change from Baseline 2 hours-post prandial plasma glucose at 3 months [3 months after intervention]

      Glycemic control

    3. Change from Baseline Total cholesterol at 3 months [3 months after intervention]

      Diabetes Mellitus control

    4. Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months [3 months after intervention]

      Diabetes Mellitus control

    5. Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months [3 months after intervention]

      Diabetes Mellitus control

    6. Change from Baseline Triglycerides at 3 months [3 months after intervention]

      Diabetes Mellitus control

    7. Mean of intake calories from food Record [at baseline, 3 months after intervention]

      mean calorief from diet intake in 3 days

    8. Global Physical Activities Questionnaire [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 [through study completion, an average of 3 months]

      Notes of daily blood glucose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Universitas Indonesia Jakarta Pusat DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Indonesia University

    Investigators

    • Principal Investigator: Pradana Soewondo, Prof, Fakultas Kedokteran Universitas Indonesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Professor, Endocrinologist, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT04271631
    Other Study ID Numbers:
    • PS001
    First Posted:
    Feb 17, 2020
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    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, Professor, Endocrinologist, Indonesia University
    Type 2 diabetes mellitus
    Mobile Application-Based Diabetes Education
    Health Coaching
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 17, 2020