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Completed

NCT Number: NCT04289818

The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients

In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c <7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching.

Education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach.

Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • T2DM patients
  • aged 30-60 years old
  • HbA1C > 7.5% within the past 3 months
  • able to write and read.

Exclusion criteria

  • Patients with cognitive disease (such as dementia)
  • having hearing problem or sight problem
  • unable to live independently on daily basis
  • having disease that may affect HbA1c result (eg: hemolytic anemia)

Treatment and study plan

Health Coaching

Other

Health Coaching as face to face with a coach

Primary outcomes

  1. Change from Baseline HbA1c at 3 months

    Time frame: 3 month after intervention

    Glycemic Control

  2. Change from Baseline HbA1c at 6 months

    Time frame: 6 month after intervention

    Glycemic Control

Secondary outcomes

  1. Change from Baseline Fasting Plasma Glucose at 3 months

    Time frame: 3 month 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 HDL-cholesterol at 3 months

    Time frame: 3 months after intervention

    Diabetes mellitus control

  4. Change from LDL-cholesterol at 3 months

    Time frame: 3 months after intervention

    Diabetes mellitus control

  5. Change from Triglycerides at 3 months

    Time frame: 3 months after intervention

    diabetes mellitus control

  6. Change from Total Cholesterol at 3 months

    Time frame: 3 months after intervention

    Diabetes mellitus control

  7. Change of Body mass index at 3 months

    Time frame: 3 month after intervention

    Diabetes mellitus control

  8. Change calorie intake at 3 months

    Time frame: 3 month after intervention

    life style parameter

  9. International Physical Activity Questionnaire (IPAQ) questionnaire

    Time frame: baseline, 3 month and 6 months after intervention

    consist of several question about activities in the whole week. Scoring divided into 3 categories : low, moderate, high. This questionnaire is to describe activities no to divided whether high score means good or bad

  10. EQ-5D quality of life questionnaire

    Time frame: baseline, 3 month and 6 months after intervention

    This questionnaire consist of several question with 5 main outcome mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Subjects will answer the question with fully, half or none.

  11. Change from Baseline Fasting Plasma Glucose at 6 months

    Time frame: 6 month after intervention

    Glycemic Control

  12. Change from Baseline 2-hours post prandial plasma glucose at 6 months

    Time frame: 6 months after intervention

    Glycemic Control

  13. Change from HDL-cholesterol at 6 months

    Time frame: 6 months after intervention

    diabetes mellitus Control

  14. Change from LDL-cholesterol at 6 months

    Time frame: 6 months after intervention

    diabetes mellitus Control

  15. Change from Triglycerides at 6 months

    Time frame: 6 months after intervention

    diabetes mellitus Control

  16. Change from Total Cholesterol at 6 months

    Time frame: 6 months after intervention

    diabetes mellitus Control

  17. Change from systolic and diastolic blood pressure at 6 months

    Time frame: 6 months after intervention

    diabetes mellitus Control

  18. Change calorie intake at 6 months

    Time frame: 6 months after intervention

    life style parameter

  19. Change of Body mass index at 6 months

    Time frame: 6 months after intervention

    diabetes mellitus control

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Feb 28, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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