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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Other: Health Coaching


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Conventional Education Class | |
| Experimental: Coaching<br>Health Coaching | Other: Health Coaching<br>* Health Coaching as face to face with a coach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c at 3 months | Glycemic Control | 3 month after intervention | 
| Change from Baseline HbA1c at 6 months | Glycemic Control | 6 month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Fasting Plasma Glucose at 3 months | Glycemic Control | 3 month after intervention | 
| Change from Baseline 2-hours post prandial plasma glucose at 3 months | Glycemic control | 3 months after intervention | 
| Change from HDL-cholesterol at 3 months | Diabetes mellitus control | 3 months after intervention | 
| Change from LDL-cholesterol at 3 months | Diabetes mellitus control | 3 months after intervention | 
| Change from Triglycerides at 3 months | diabetes mellitus control | 3 months after intervention | 
| Change from Total Cholesterol at 3 months | Diabetes mellitus control | 3 months after intervention | 
| Change of Body mass index at 3 months | Diabetes mellitus control | 3 month after intervention | 
| Change calorie intake at 3 months | life style parameter | 3 month after intervention | 
| International Physical Activity Questionnaire (IPAQ) questionnaire | 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 | baseline, 3 month and 6 months after intervention | 
| EQ-5D quality of life questionnaire | 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. | baseline, 3 month and 6 months after intervention | 
| Change from Baseline Fasting Plasma Glucose at 6 months | Glycemic Control | 6 month after intervention | 
| Change from Baseline 2-hours post prandial plasma glucose at 6 months | Glycemic Control | 6 months after intervention | 
| Change from HDL-cholesterol at 6 months | diabetes mellitus Control | 6 months after intervention | 
| Change from LDL-cholesterol at 6 months | diabetes mellitus Control | 6 months after intervention | 
| Change from Triglycerides at 6 months | diabetes mellitus Control | 6 months after intervention | 
| Change from Total Cholesterol at 6 months | diabetes mellitus Control | 6 months after intervention | 
| Change from systolic and diastolic blood pressure at 6 months | diabetes mellitus Control | 6 months after intervention | 
| Change calorie intake at 6 months | life style parameter | 6 months after intervention | 
| Change of Body mass index at 6 months | diabetes mellitus control | 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Health coaching