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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05090488

Collaborator

Provincial Health Services Authority (Other)

200

Enrollment

Location

Arms

29.5

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Diabetes Mellitus, Type 2 Endocrine System Diseases Nutritional and Metabolic Diseases Glucose Metabolism Disorders (Including Diabetes Mellitus) Diabetes Mellitus	Behavioral: Personal Health Coaching and Diabetes Education in Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 14, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline HbA1C at 3 months and 6 months [Baseline, 3 and 6 months after intervention]
HbA1C is indicator of glycemic control

Secondary Outcome Measures

Change from baseline fasting plasma glucose at 3 and 6 months [Baseline, 3 and 6 months after intervention]
Blood glucose monitoring
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
Baseline lens haziness [Baseline]
Lens haziness was evaluated using shadow test
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).