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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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
University of Indonesia
Jakarta, DKI Jakarta, Indonesia
RECRUITINGChange from baseline HbA1C at 3 months and 6 months
HbA1C is indicator of glycemic control
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline fasting plasma glucose at 3 and 6 months
Blood glucose monitoring
Time frame: 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
Time frame: 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)
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline body mass index
Body mass index described by kg/m2
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline waist circumference
Waist circumference measured by cm
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline body fat
Body fat measured by body impedance analysis
Time frame: 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
Time frame: 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)
Time frame: Baseline, 6 months after intervention
Change from baseline left atrial volume
Left atrial volume was measured through biplane area calculation in echocardiography procedure
Time frame: Baseline, 6 months after intervention
Change from baseline right ventricular systolic function
Right ventricular systolic function was evaluated using TAPSE
Time frame: 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
Time frame: Baseline, 6 months after intervention
Change from baseline electrocardiography pattern
Electrocardiography pattern was used to analyze cardiac rythm
Time frame: Baseline and 6 months after intervention
Change from baseline heart rate variability
Heart rate variability was measured using ECG Holter examination
Time frame: Baseline and 6 months after intervention
Baseline visual acuity
Visual acuity was measured by Peek acuity chart application using WHO classification
Time frame: Baseline
Baseline lens haziness
Lens haziness was evaluated using shadow test
Time frame: Baseline
Baseline retina examination
Retina was examined using funduscopic photography
Time frame: Baseline
Baseline intraocular pressure
Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline peripheral arterial disease
Peripheral arterial disease was diagnosed through ankle brachial index measurement
Time frame: 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
Time frame: Baseline and 6 months after intervention
Change from baseline albuminuria
Albuminuria was measured by albumin creatinine ratio
Time frame: Baseline and 6 months after intervention
Change from baseline mean calorie intake
Evaluation of mean calorie intake using food record data
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline global physical activity
Global physical activity was evaluated by global physical activity questionnaire
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline medication adherence
Medication adherence was measured by Morisky Medication Adherence Scale (MMAS)
Time frame: 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).
Time frame: Baseline, 3 and 6 months
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