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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04289818
Enrollment
60
Registered
2020-02-28
Start date
2018-02-01
Completion date
2020-03-31
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

Keywords

Diabetes Mellitus, Health coaching

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.

Interventions

OTHERHealth Coaching

Health Coaching as face to face with a coach

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline HbA1c at 3 months3 month after interventionGlycemic Control
Change from Baseline HbA1c at 6 months6 month after interventionGlycemic Control

Secondary

MeasureTime frameDescription
Change from Baseline 2-hours post prandial plasma glucose at 3 months3 months after interventionGlycemic control
Change from HDL-cholesterol at 3 months3 months after interventionDiabetes mellitus control
Change from LDL-cholesterol at 3 months3 months after interventionDiabetes mellitus control
Change from Triglycerides at 3 months3 months after interventiondiabetes mellitus control
Change from Total Cholesterol at 3 months3 months after interventionDiabetes mellitus control
Change of Body mass index at 3 months3 month after interventionDiabetes mellitus control
Change calorie intake at 3 months3 month after interventionlife style parameter
International Physical Activity Questionnaire (IPAQ) questionnairebaseline, 3 month and 6 months after interventionconsist 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
Change of Body mass index at 6 months6 months after interventiondiabetes mellitus control
Change from Baseline Fasting Plasma Glucose at 6 months6 month after interventionGlycemic Control
Change from Baseline 2-hours post prandial plasma glucose at 6 months6 months after interventionGlycemic Control
Change from HDL-cholesterol at 6 months6 months after interventiondiabetes mellitus Control
Change from LDL-cholesterol at 6 months6 months after interventiondiabetes mellitus Control
Change from Triglycerides at 6 months6 months after interventiondiabetes mellitus Control
Change from Total Cholesterol at 6 months6 months after interventiondiabetes mellitus Control
Change from systolic and diastolic blood pressure at 6 months6 months after interventiondiabetes mellitus Control
Change calorie intake at 6 months6 months after interventionlife style parameter
EQ-5D quality of life questionnairebaseline, 3 month and 6 months after interventionThis 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 3 months3 month after interventionGlycemic Control

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026