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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289818
• Other study ID #: PS002
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2020
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Other:
• Health Coaching
Health Coaching as face to face with a coach

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HbA1c at 3 months	Glycemic Control	3 month after intervention
Primary	Change from Baseline HbA1c at 6 months	Glycemic Control	6 month after intervention
Secondary	Change from Baseline Fasting Plasma Glucose at 3 months	Glycemic Control	3 month after intervention
Secondary	Change from Baseline 2-hours post prandial plasma glucose at 3 months	Glycemic control	3 months after intervention
Secondary	Change from HDL-cholesterol at 3 months	Diabetes mellitus control	3 months after intervention
Secondary	Change from LDL-cholesterol at 3 months	Diabetes mellitus control	3 months after intervention
Secondary	Change from Triglycerides at 3 months	diabetes mellitus control	3 months after intervention
Secondary	Change from Total Cholesterol at 3 months	Diabetes mellitus control	3 months after intervention
Secondary	Change of Body mass index at 3 months	Diabetes mellitus control	3 month after intervention
Secondary	Change calorie intake at 3 months	life style parameter	3 month after intervention
Secondary	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
Secondary	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
Secondary	Change from Baseline Fasting Plasma Glucose at 6 months	Glycemic Control	6 month after intervention
Secondary	Change from Baseline 2-hours post prandial plasma glucose at 6 months	Glycemic Control	6 months after intervention
Secondary	Change from HDL-cholesterol at 6 months	diabetes mellitus Control	6 months after intervention
Secondary	Change from LDL-cholesterol at 6 months	diabetes mellitus Control	6 months after intervention
Secondary	Change from Triglycerides at 6 months	diabetes mellitus Control	6 months after intervention
Secondary	Change from Total Cholesterol at 6 months	diabetes mellitus Control	6 months after intervention
Secondary	Change from systolic and diastolic blood pressure at 6 months	diabetes mellitus Control	6 months after intervention
Secondary	Change calorie intake at 6 months	life style parameter	6 months after intervention
Secondary	Change of Body mass index at 6 months	diabetes mellitus control	6 months after intervention