The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
- Conditions
- Diabetes Type 2
- Interventions
- Other: Health Coaching
- Registration Number
- NCT04289818
- Lead Sponsor
- Indonesia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- T2DM patients
- aged 30-60 years old
- HbA1C > 7.5% within the past 3 months
- able to write and read.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coaching Health Coaching Health Coaching
- Primary Outcome Measures
Name Time Method Change from Baseline HbA1c at 3 months 3 month after intervention Glycemic Control
Change from Baseline HbA1c at 6 months 6 month after intervention Glycemic Control
- Secondary Outcome Measures
Name Time Method Change of Body mass index at 3 months 3 month after intervention Diabetes mellitus control
Change calorie intake at 3 months 3 month after intervention life style parameter
Change from Baseline 2-hours post prandial plasma glucose at 6 months 6 months after intervention Glycemic Control
Change of Body mass index at 6 months 6 months after intervention diabetes mellitus control
Change from Baseline 2-hours post prandial plasma glucose at 3 months 3 months after intervention Glycemic control
Change from HDL-cholesterol at 3 months 3 months after intervention Diabetes mellitus control
International Physical Activity Questionnaire (IPAQ) questionnaire baseline, 3 month and 6 months after intervention 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
Change from Total Cholesterol at 6 months 6 months after intervention diabetes mellitus Control
Change calorie intake at 6 months 6 months after intervention life style parameter
Change from Total Cholesterol at 3 months 3 months after intervention Diabetes mellitus control
EQ-5D quality of life questionnaire baseline, 3 month and 6 months after intervention 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 HDL-cholesterol at 6 months 6 months after intervention diabetes mellitus Control
Change from Triglycerides at 6 months 6 months after intervention diabetes mellitus Control
Change from Baseline Fasting Plasma Glucose at 3 months 3 month after intervention Glycemic Control
Change from Baseline Fasting Plasma Glucose at 6 months 6 month after intervention Glycemic Control
Change from LDL-cholesterol at 6 months 6 months after intervention diabetes mellitus Control
Change from systolic and diastolic blood pressure at 6 months 6 months after intervention diabetes mellitus Control
Change from LDL-cholesterol at 3 months 3 months after intervention Diabetes mellitus control
Change from Triglycerides at 3 months 3 months after intervention diabetes mellitus control
Trial Locations
- Locations (1)
Faculty of Medicine, Universitas Indonesia
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia