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

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Type2 Diabetes; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Intervention / Treatment: Behavioral: Personal Health Coaching and Diabetes Education in Group

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Em Yunir, PhD; Phone Number: +811161094; Email: e.yunir@ui.ac.id
• Study Contact Backup: Name: Syahidatul Wafa, MD; Phone Number: +81210809278; Email: Dokter.wafa@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Recruiting
      • University of Indonesia
      • Contact: Em Yunir, PhD; Phone Number: +811161094; Email: e.yunir@ui.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Received 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	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
Active Comparator: Received Diabetes Education in Group; Diabetes education in group, with trained educator team from primary health care	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Provincial Health Services Authority
• Investigators: Principal Investigator: Em Yunir, PhD, Divisi Metabolik Endokrin IPD FKUI RSCM

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Health Coaching; Type 2 Diabetes Mellitus; Diabetes Education
• Additional Relevant MeSH Terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: Health Coaching Jakarta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No