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The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Health Coaching
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Type 2 focused on measuring Diabetes Mellitus, Health coaching

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T2DM patients
  • aged 30-60 years old
  • HbA1C > 7.5% within the past 3 months
  • able to write and read.

Exclusion Criteria:

  • Patients with cognitive disease (such as dementia)
  • having hearing problem or sight problem
  • unable to live independently on daily basis
  • having disease that may affect HbA1c result (eg: hemolytic anemia)

Sites / Locations

  • Faculty of Medicine, Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Coaching

Arm Description

Conventional Education Class

Health Coaching

Outcomes

Primary Outcome Measures

Change from Baseline HbA1c at 3 months
Glycemic Control
Change from Baseline HbA1c at 6 months
Glycemic Control

Secondary Outcome Measures

Change from Baseline Fasting Plasma Glucose at 3 months
Glycemic Control
Change from Baseline 2-hours post prandial plasma glucose at 3 months
Glycemic control
Change from HDL-cholesterol at 3 months
Diabetes mellitus control
Change from LDL-cholesterol at 3 months
Diabetes mellitus control
Change from Triglycerides at 3 months
diabetes mellitus control
Change from Total Cholesterol at 3 months
Diabetes mellitus control
Change of Body mass index at 3 months
Diabetes mellitus control
Change calorie intake at 3 months
life style parameter
International Physical Activity Questionnaire (IPAQ) questionnaire
consist of several question about activities in the whole week. Scoring divided into 3 categories : low, moderate, high. This questionnaire is to describe activities no to divided whether high score means good or bad
EQ-5D quality of life questionnaire
This questionnaire consist of several question with 5 main outcome mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Subjects will answer the question with fully, half or none.
Change from Baseline Fasting Plasma Glucose at 6 months
Glycemic Control
Change from Baseline 2-hours post prandial plasma glucose at 6 months
Glycemic Control
Change from HDL-cholesterol at 6 months
diabetes mellitus Control
Change from LDL-cholesterol at 6 months
diabetes mellitus Control
Change from Triglycerides at 6 months
diabetes mellitus Control
Change from Total Cholesterol at 6 months
diabetes mellitus Control
Change from systolic and diastolic blood pressure at 6 months
diabetes mellitus Control
Change calorie intake at 6 months
life style parameter
Change of Body mass index at 6 months
diabetes mellitus control

Full Information

First Posted
February 10, 2020
Last Updated
November 1, 2022
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04289818
Brief Title
The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
Official Title
Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c <7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.
Detailed Description
Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching. Education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach. Laboratory examination 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
Diabetes Type 2
Keywords
Diabetes Mellitus, Health coaching

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional Education Class
Arm Title
Coaching
Arm Type
Experimental
Arm Description
Health Coaching
Intervention Type
Other
Intervention Name(s)
Health Coaching
Intervention Description
Health Coaching as face to face with a coach
Primary Outcome Measure Information:
Title
Change from Baseline HbA1c at 3 months
Description
Glycemic Control
Time Frame
3 month after intervention
Title
Change from Baseline HbA1c at 6 months
Description
Glycemic Control
Time Frame
6 month after intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Fasting Plasma Glucose at 3 months
Description
Glycemic Control
Time Frame
3 month after intervention
Title
Change from Baseline 2-hours post prandial plasma glucose at 3 months
Description
Glycemic control
Time Frame
3 months after intervention
Title
Change from HDL-cholesterol at 3 months
Description
Diabetes mellitus control
Time Frame
3 months after intervention
Title
Change from LDL-cholesterol at 3 months
Description
Diabetes mellitus control
Time Frame
3 months after intervention
Title
Change from Triglycerides at 3 months
Description
diabetes mellitus control
Time Frame
3 months after intervention
Title
Change from Total Cholesterol at 3 months
Description
Diabetes mellitus control
Time Frame
3 months after intervention
Title
Change of Body mass index at 3 months
Description
Diabetes mellitus control
Time Frame
3 month after intervention
Title
Change calorie intake at 3 months
Description
life style parameter
Time Frame
3 month after intervention
Title
International Physical Activity Questionnaire (IPAQ) questionnaire
Description
consist of several question about activities in the whole week. Scoring divided into 3 categories : low, moderate, high. This questionnaire is to describe activities no to divided whether high score means good or bad
Time Frame
baseline, 3 month and 6 months after intervention
Title
EQ-5D quality of life questionnaire
Description
This questionnaire consist of several question with 5 main outcome mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Subjects will answer the question with fully, half or none.
Time Frame
baseline, 3 month and 6 months after intervention
Title
Change from Baseline Fasting Plasma Glucose at 6 months
Description
Glycemic Control
Time Frame
6 month after intervention
Title
Change from Baseline 2-hours post prandial plasma glucose at 6 months
Description
Glycemic Control
Time Frame
6 months after intervention
Title
Change from HDL-cholesterol at 6 months
Description
diabetes mellitus Control
Time Frame
6 months after intervention
Title
Change from LDL-cholesterol at 6 months
Description
diabetes mellitus Control
Time Frame
6 months after intervention
Title
Change from Triglycerides at 6 months
Description
diabetes mellitus Control
Time Frame
6 months after intervention
Title
Change from Total Cholesterol at 6 months
Description
diabetes mellitus Control
Time Frame
6 months after intervention
Title
Change from systolic and diastolic blood pressure at 6 months
Description
diabetes mellitus Control
Time Frame
6 months after intervention
Title
Change calorie intake at 6 months
Description
life style parameter
Time Frame
6 months after intervention
Title
Change of Body mass index at 6 months
Description
diabetes mellitus control
Time Frame
6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: T2DM patients aged 30-60 years old HbA1C > 7.5% within the past 3 months able to write and read. Exclusion Criteria: Patients with cognitive disease (such as dementia) having hearing problem or sight problem unable to live independently on daily basis having disease that may affect HbA1c result (eg: hemolytic anemia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradana Soewondo, Prof
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Universitas Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients

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