Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health Care

Study Overview
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Brief Summary
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Type 2 Diabetes Mellitus is a chronic disease with increasing incidence globally. It needs a comprehensive and continuous management approach that includes five pillars: education, nutritional management, physical activity, pharmacological treatment, and monitoring. To achieve good glycemic control, prevention of complications, and good quality of life as diabetes management goals, patients' capability to properly navigate diabetes management is a key. One evidence-based model to empower patients' self-management abilities is diabetes education and health coaching. Diabetes management at primary health care needs special concern since they play an important role in initial and continuing care for diabetes patients in the community. Therefore, the implementation of diabetes education and health coaching in primary health care is expected to improve the self-management abilities of people with diabetes

Detailed Description
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A randomized control trial, pre and post study involving 180 subjects randomized into 2 arms: Control : received education in group Intervention : received education group + personal health coaching Education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes. 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, anthropometric measurement, echocardiography, electrocardiography, Heart Rate Variability measurement, diabetic eye screening, and questionnaire collected at baseline, 3 and 6 months after intervention

Official Title
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The Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Patients at Jakarta Primary Health Care: Role on Metabolic Control, Diabetes Complications, Inflammatory Marker, Behavior Changes, and Quality of Life

Conditions
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Type2 Diabetes, Diabetes Mellitus, Type 2, Endocrine System Diseases, Nutritional and Metabolic Diseases, Glucose Metabolism Disorders (Including Diabetes Mellitus), Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Personal Health Coaching and Diabetes Education in Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes Mellitus >= 18 years old 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

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Received Personal Health Coaching and Diabetes Education in Group<br>Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care | Behavioral: Personal Health Coaching and Diabetes Education in Group<br>* Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care<br>|
| Active Comparator: Received Diabetes Education in Group<br>Diabetes education in group, with trained educator team from primary health care | Behavioral: Personal Health Coaching and Diabetes Education in Group<br>* Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care<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 and 6 months | HbA1C is indicator of glycemic control | Baseline, 3 and 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline fasting plasma glucose at 3 and 6 months | Blood glucose monitoring | Baseline, 3 and 6 months after intervention | 
| Change from baseline serum lipid at 3 and 6 months | Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides | Baseline, 3 and 6 months after intervention | 
| Change from baseline inflammatory marker at 3 and 6 months | Inflammatory marker used is hs-CRP (C-reactive protein) | Baseline, 3 and 6 months after intervention | 
| Change from baseline body mass index | Body mass index described by kg/m2 | Baseline, 3 and 6 months after intervention | 
| Change from baseline waist circumference | Waist circumference measured by cm | Baseline, 3 and 6 months after intervention | 
| Change from baseline body fat | Body fat measured by body impedance analysis | Baseline, 3 and 6 months after intervention | 
| Change from baseline left ventricular mass index | Left ventricular mass index measured using standard formula and corrected by body surface area | Baseline, 6 months after intervention | 
| Change from baseline left ventricular systolic function | Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography) | Baseline, 6 months after intervention | 
| Change from baseline left atrial volume | Left atrial volume was measured through biplane area calculation in echocardiography procedure | Baseline, 6 months after intervention | 
| Change from baseline right ventricular systolic function | Right ventricular systolic function was evaluated using TAPSE | Baseline, 6 months after intervention | 
| change from baseline left ventricular diastolic function | LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016 | Baseline, 6 months after intervention | 
| Change from baseline electrocardiography pattern | Electrocardiography pattern was used to analyze cardiac rythm | Baseline and 6 months after intervention | 
| Change from baseline heart rate variability | Heart rate variability was measured using ECG Holter examination | Baseline and 6 months after intervention | 
| Baseline visual acuity | Visual acuity was measured by Peek acuity chart application using WHO classification | Baseline | 
| Baseline lens haziness | Lens haziness was evaluated using shadow test | Baseline | 
| Baseline retina examination | Retina was examined using funduscopic photography | Baseline | 
| Baseline intraocular pressure | Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy | Baseline | 
| Change from baseline peripheral sensory neuropathy | Peripheral sensory neuropathy was measured using combination of subjective manifestation, 10 g Simme Weinstein monofilament and 128 Hz tuning fork | Baseline, 3 and 6 months after intervention | 
| Change from baseline peripheral autonomic neuropathy | Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin) | Baseline, 3 and 6 months after intervention | 
| Change from baseline peripheral motor neuropathy | Peripheral motor neuropathy was seen visually by objective examination (changes in the shape of fingers, muscle atrophy, or bone protrusions) | Baseline, 3 and 6 months after intervention | 
| Change from baseline peripheral arterial disease | Peripheral arterial disease was diagnosed through ankle brachial index measurement | Baseline, 3 and 6 months after intervention | 
| Change from baseline renal function | Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data | Baseline and 6 months after intervention | 
| Change from baseline albuminuria | Albuminuria was measured by albumin creatinine ratio | Baseline and 6 months after intervention | 
| Change from baseline mean calorie intake | Evaluation of mean calorie intake using food record data | Baseline, 3 and 6 months after intervention | 
| Change from baseline global physical activity | Global physical activity was evaluated by global physical activity questionnaire | Baseline, 3 and 6 months after intervention | 
| Change from baseline medication adherence | Medication adherence was measured by Morisky Medication Adherence Scale (MMAS) | Baseline, 3 and 6 months | 
| Change from baseline quality of life | Quality of life was evaluated by EuroQol five-dimensional questionnaire. This questionnaire evaluates 5 dimensions of life. Each dimension scores 1-5 (1 means no problem and 5 means extreme problems). | Baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Diabetes Education, Health Coaching