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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090488
• Other study ID #: Health Coaching Jakarta
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Indonesia University
• Contact: Em Yunir, PhD
• Phone: +811161094
• Email: e.yunir[@]ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Personal 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

Locations

Country	Name	City	State
Indonesia	University of Indonesia	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Provincial Health Services Authority

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline HbA1C at 3 months and 6 months	HbA1C is indicator of glycemic control	Baseline, 3 and 6 months after intervention
Secondary	Change from baseline fasting plasma glucose at 3 and 6 months	Blood glucose monitoring	Baseline, 3 and 6 months after intervention
Secondary	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
Secondary	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
Secondary	Change from baseline body mass index	Body mass index described by kg/m2	Baseline, 3 and 6 months after intervention
Secondary	Change from baseline waist circumference	Waist circumference measured by cm	Baseline, 3 and 6 months after intervention
Secondary	Change from baseline body fat	Body fat measured by body impedance analysis	Baseline, 3 and 6 months after intervention
Secondary	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
Secondary	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
Secondary	Change from baseline left atrial volume	Left atrial volume was measured through biplane area calculation in echocardiography procedure	Baseline, 6 months after intervention
Secondary	Change from baseline right ventricular systolic function	Right ventricular systolic function was evaluated using TAPSE	Baseline, 6 months after intervention
Secondary	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
Secondary	Change from baseline electrocardiography pattern	Electrocardiography pattern was used to analyze cardiac rythm	Baseline and 6 months after intervention
Secondary	Change from baseline heart rate variability	Heart rate variability was measured using ECG Holter examination	Baseline and 6 months after intervention
Secondary	Baseline visual acuity	Visual acuity was measured by Peek acuity chart application using WHO classification	Baseline
Secondary	Baseline lens haziness	Lens haziness was evaluated using shadow test	Baseline
Secondary	Baseline retina examination	Retina was examined using funduscopic photography	Baseline
Secondary	Baseline intraocular pressure	Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline peripheral arterial disease	Peripheral arterial disease was diagnosed through ankle brachial index measurement	Baseline, 3 and 6 months after intervention
Secondary	Change from baseline renal function	Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data	Baseline and 6 months after intervention
Secondary	Change from baseline albuminuria	Albuminuria was measured by albumin creatinine ratio	Baseline and 6 months after intervention
Secondary	Change from baseline mean calorie intake	Evaluation of mean calorie intake using food record data	Baseline, 3 and 6 months after intervention
Secondary	Change from baseline global physical activity	Global physical activity was evaluated by global physical activity questionnaire	Baseline, 3 and 6 months after intervention
Secondary	Change from baseline medication adherence	Medication adherence was measured by Morisky Medication Adherence Scale (MMAS)	Baseline, 3 and 6 months
Secondary	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