Diabetes Mellitus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders (Including Diabetes Mellitus), Nutritional and Metabolic Diseases, Type2 Diabetes
Conditions
Keywords
Type 2 Diabetes Mellitus, Diabetes Education, Health Coaching
Brief summary
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
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
Interventions
BEHAVIORALPersonal Health Coaching and Diabetes Education in Group
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
Sponsors
Provincial Health Services Authority British Columbia
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline HbA1C at 3 months and 6 months | Baseline, 3 and 6 months after intervention | HbA1C is indicator of glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline serum lipid at 3 and 6 months | Baseline, 3 and 6 months after intervention | Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides |
| Change from baseline inflammatory marker at 3 and 6 months | Baseline, 3 and 6 months after intervention | Inflammatory marker used is hs-CRP (C-reactive protein) |
| Change from baseline body mass index | Baseline, 3 and 6 months after intervention | Body mass index described by kg/m2 |
| Change from baseline waist circumference | Baseline, 3 and 6 months after intervention | Waist circumference measured by cm |
| Change from baseline body fat | Baseline, 3 and 6 months after intervention | Body fat measured by body impedance analysis |
| Change from baseline left ventricular mass index | Baseline, 6 months after intervention | Left ventricular mass index measured using standard formula and corrected by body surface area |
| Change from baseline left ventricular systolic function | Baseline, 6 months after intervention | Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography) |
| Change from baseline left atrial volume | Baseline, 6 months after intervention | Left atrial volume was measured through biplane area calculation in echocardiography procedure |
| Change from baseline right ventricular systolic function | Baseline, 6 months after intervention | Right ventricular systolic function was evaluated using TAPSE |
| change from baseline left ventricular diastolic function | Baseline, 6 months after intervention | LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016 |
| Change from baseline electrocardiography pattern | Baseline and 6 months after intervention | Electrocardiography pattern was used to analyze cardiac rythm |
| Change from baseline heart rate variability | Baseline and 6 months after intervention | Heart rate variability was measured using ECG Holter examination |
| Baseline visual acuity | Baseline | Visual acuity was measured by Peek acuity chart application using WHO classification |
| Change from baseline fasting plasma glucose at 3 and 6 months | Baseline, 3 and 6 months after intervention | Blood glucose monitoring |
| Baseline retina examination | Baseline | Retina was examined using funduscopic photography |
| Baseline intraocular pressure | Baseline | Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy |
| Change from baseline peripheral sensory neuropathy | Baseline, 3 and 6 months after intervention | Peripheral sensory neuropathy was measured using combination of subjective manifestation, 10 g Simme Weinstein monofilament and 128 Hz tuning fork |
| Change from baseline peripheral autonomic neuropathy | Baseline, 3 and 6 months after intervention | Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin) |
| Change from baseline peripheral motor neuropathy | Baseline, 3 and 6 months after intervention | Peripheral motor neuropathy was seen visually by objective examination (changes in the shape of fingers, muscle atrophy, or bone protrusions) |
| Change from baseline peripheral arterial disease | Baseline, 3 and 6 months after intervention | Peripheral arterial disease was diagnosed through ankle brachial index measurement |
| Change from baseline renal function | Baseline and 6 months after intervention | Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data |
| Change from baseline albuminuria | Baseline and 6 months after intervention | Albuminuria was measured by albumin creatinine ratio |
| Change from baseline mean calorie intake | Baseline, 3 and 6 months after intervention | Evaluation of mean calorie intake using food record data |
| Change from baseline global physical activity | Baseline, 3 and 6 months after intervention | Global physical activity was evaluated by global physical activity questionnaire |
| Change from baseline medication adherence | Baseline, 3 and 6 months | Medication adherence was measured by Morisky Medication Adherence Scale (MMAS) |
| Change from baseline quality of life | Baseline, 3 and 6 months | 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 lens haziness | Baseline | Lens haziness was evaluated using shadow test |
Countries
Indonesia
Contacts
Primary ContactEm Yunir, PhD
Backup ContactSyahidatul Wafa, MD
Outcome results
None listed