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

Primary Purpose

Type2 Diabetes, Diabetes Mellitus, Type 2, Endocrine System Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Personal Health Coaching and Diabetes Education in Group

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring Type 2 Diabetes Mellitus, Diabetes Education, Health Coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Received Personal Health Coaching and Diabetes Education in Group

Received Diabetes Education in Group

Arm Description

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

Diabetes education in group, with trained educator team from primary health care

Outcomes

Primary Outcome Measures

Change from baseline HbA1C at 3 months and 6 months

HbA1C is indicator of glycemic control

Secondary Outcome Measures

Change from baseline fasting plasma glucose at 3 and 6 months

Blood glucose monitoring

Change from baseline serum lipid at 3 and 6 months

Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides

Change from baseline inflammatory marker at 3 and 6 months

Inflammatory marker used is hs-CRP (C-reactive protein)

Change from baseline body mass index

Body mass index described by kg/m2

Change from baseline waist circumference

Waist circumference measured by cm

Change from baseline body fat

Body fat measured by body impedance analysis

Change from baseline left ventricular mass index

Left ventricular mass index measured using standard formula and corrected by body surface area

Change from baseline left ventricular systolic function

Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography)

Change from baseline left atrial volume

Left atrial volume was measured through biplane area calculation in echocardiography procedure

Change from baseline right ventricular systolic function

Right ventricular systolic function was evaluated using TAPSE

change from baseline left ventricular diastolic function

LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016

Change from baseline electrocardiography pattern

Electrocardiography pattern was used to analyze cardiac rythm

Change from baseline heart rate variability

Heart rate variability was measured using ECG Holter examination

Baseline visual acuity

Visual acuity was measured by Peek acuity chart application using WHO classification

Baseline lens haziness

Lens haziness was evaluated using shadow test

Baseline retina examination

Retina was examined using funduscopic photography

Baseline intraocular pressure

Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy

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

Change from baseline peripheral autonomic neuropathy

Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin)

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)

Change from baseline peripheral arterial disease

Peripheral arterial disease was diagnosed through ankle brachial index measurement

Change from baseline renal function

Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data

Change from baseline albuminuria

Albuminuria was measured by albumin creatinine ratio

Change from baseline mean calorie intake

Evaluation of mean calorie intake using food record data

Change from baseline global physical activity

Global physical activity was evaluated by global physical activity questionnaire

Change from baseline medication adherence

Medication adherence was measured by Morisky Medication Adherence Scale (MMAS)

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).

Full Information

NCT ID

NCT05090488

First Posted

February 11, 2021

Last Updated

April 18, 2022

Sponsor

Indonesia University

Collaborators

Provincial Health Services Authority

1. Study Identification

Unique Protocol Identification Number

NCT05090488

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2020 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

Collaborators

Provincial Health Services Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Type 2 Diabetes Mellitus, Diabetes Education, Health Coaching

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Received Personal Health Coaching and Diabetes Education in Group

Arm Type

Experimental

Arm Description

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 Title

Received Diabetes Education in Group

Arm Type

Active Comparator

Arm Description

Diabetes education in group, with trained educator team from primary health care

Intervention Type

Behavioral

Intervention Name(s)

Personal Health Coaching and Diabetes Education in Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline HbA1C at 3 months and 6 months

Description

HbA1C is indicator of glycemic control

Time Frame

Baseline, 3 and 6 months after intervention

Secondary Outcome Measure Information:

Title

Change from baseline fasting plasma glucose at 3 and 6 months

Description

Blood glucose monitoring

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline serum lipid at 3 and 6 months

Description

Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline inflammatory marker at 3 and 6 months

Description

Inflammatory marker used is hs-CRP (C-reactive protein)

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline body mass index

Description

Body mass index described by kg/m2

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline waist circumference

Description

Waist circumference measured by cm

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline body fat

Description

Body fat measured by body impedance analysis

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline left ventricular mass index

Description

Left ventricular mass index measured using standard formula and corrected by body surface area

Time Frame

Baseline, 6 months after intervention

Title

Change from baseline left ventricular systolic function

Description

Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography)

Time Frame

Baseline, 6 months after intervention

Title

Change from baseline left atrial volume

Description

Left atrial volume was measured through biplane area calculation in echocardiography procedure

Time Frame

Baseline, 6 months after intervention

Title

Change from baseline right ventricular systolic function

Description

Right ventricular systolic function was evaluated using TAPSE

Time Frame

Baseline, 6 months after intervention

Title

change from baseline left ventricular diastolic function

Description

LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016

Time Frame

Baseline, 6 months after intervention

Title

Change from baseline electrocardiography pattern

Description

Electrocardiography pattern was used to analyze cardiac rythm

Time Frame

Baseline and 6 months after intervention

Title

Change from baseline heart rate variability

Description

Heart rate variability was measured using ECG Holter examination

Time Frame

Baseline and 6 months after intervention

Title

Baseline visual acuity

Description

Visual acuity was measured by Peek acuity chart application using WHO classification

Time Frame

Baseline

Title

Baseline lens haziness

Description

Lens haziness was evaluated using shadow test

Time Frame

Baseline

Title

Baseline retina examination

Description

Retina was examined using funduscopic photography

Time Frame

Baseline

Title

Baseline intraocular pressure

Description

Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy

Time Frame

Baseline

Title

Change from baseline peripheral sensory neuropathy

Description

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

Title

Change from baseline peripheral autonomic neuropathy

Description

Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin)

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline peripheral motor neuropathy

Description

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

Title

Change from baseline peripheral arterial disease

Description

Peripheral arterial disease was diagnosed through ankle brachial index measurement

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline renal function

Description

Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data

Time Frame

Baseline and 6 months after intervention

Title

Change from baseline albuminuria

Description

Albuminuria was measured by albumin creatinine ratio

Time Frame

Baseline and 6 months after intervention

Title

Change from baseline mean calorie intake

Description

Evaluation of mean calorie intake using food record data

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline global physical activity

Description

Global physical activity was evaluated by global physical activity questionnaire

Time Frame

Baseline, 3 and 6 months after intervention

Title

Change from baseline medication adherence

Description

Medication adherence was measured by Morisky Medication Adherence Scale (MMAS)

Time Frame

Baseline, 3 and 6 months

Title

Change from baseline quality of life

Description

Time Frame

Baseline, 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Em Yunir, PhD

Phone

+811161094

e.yunir@ui.ac.id

First Name & Middle Initial & Last Name or Official Title & Degree

Syahidatul Wafa, MD

Phone

+81210809278

Dokter.wafa@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Em Yunir, PhD

Organizational Affiliation

Divisi Metabolik Endokrin IPD FKUI RSCM

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Indonesia

City

Jakarta

State/Province

DKI Jakarta

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Em Yunir, PhD

Phone

+811161094

e.yunir@ui.ac.id

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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