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

Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Other: Health Coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Conventional Education Class
Experimental: Coaching; Health Coaching	Other: Health Coaching; Health Coaching as face to face with a coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline HbA1c at 3 months	Glycemic Control	3 month after intervention
Change from Baseline HbA1c at 6 months	Glycemic Control	6 month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Fasting Plasma Glucose at 3 months	Glycemic Control	3 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 3 months	Glycemic control	3 months after intervention
Change from HDL-cholesterol at 3 months	Diabetes mellitus control	3 months after intervention
Change from LDL-cholesterol at 3 months	Diabetes mellitus control	3 months after intervention
Change from Triglycerides at 3 months	diabetes mellitus control	3 months after intervention
Change from Total Cholesterol at 3 months	Diabetes mellitus control	3 months after intervention
Change of Body mass index at 3 months	Diabetes mellitus control	3 month after intervention
Change calorie intake at 3 months	life style parameter	3 month after intervention
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	baseline, 3 month and 6 months after intervention
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.	baseline, 3 month and 6 months after intervention
Change from Baseline Fasting Plasma Glucose at 6 months	Glycemic Control	6 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 6 months	Glycemic Control	6 months after intervention
Change from HDL-cholesterol at 6 months	diabetes mellitus Control	6 months after intervention
Change from LDL-cholesterol at 6 months	diabetes mellitus Control	6 months after intervention
Change from Triglycerides at 6 months	diabetes mellitus Control	6 months after intervention
Change from Total Cholesterol at 6 months	diabetes mellitus Control	6 months after intervention
Change from systolic and diastolic blood pressure at 6 months	diabetes mellitus Control	6 months after intervention
Change calorie intake at 6 months	life style parameter	6 months after intervention
Change of Body mass index at 6 months	diabetes mellitus control	6 months after intervention

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Pradana Soewondo, Prof, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Health coaching
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PS002

Drug and device information, study documents

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