Clinical trial NCT04289818: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes Mellitus
Health coaching
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change from Baseline HbA1c at 3 months
timeFrame: 3 month after intervention
measure: Change from Baseline HbA1c at 6 months
timeFrame: 6 month after intervention
Secondary outcomes:
measure: Change from Baseline Fasting Plasma Glucose at 3 months
timeFrame: 3 month after intervention
measure: Change from Baseline 2-hours post prandial plasma glucose at 3 months
timeFrame: 3 months after intervention
measure: Change from HDL-cholesterol at 3 months
timeFrame: 3 months after intervention
measure: Change from LDL-cholesterol at 3 months
timeFrame: 3 months after intervention
measure: Change from Triglycerides at 3 months
timeFrame: 3 months after intervention
measure: Change from Total Cholesterol at 3 months
timeFrame: 3 months after intervention
measure: Change of Body mass index at 3 months
timeFrame: 3 month after intervention
measure: Change calorie intake at 3 months
timeFrame: 3 month after intervention
measure: International Physical Activity Questionnaire (IPAQ) questionnaire
timeFrame: baseline, 3 month and 6 months after intervention
measure: EQ-5D quality of life questionnaire
timeFrame: baseline, 3 month and 6 months after intervention
measure: Change from Baseline Fasting Plasma Glucose at 6 months
timeFrame: 6 month after intervention
measure: Change from Baseline 2-hours post prandial plasma glucose at 6 months
timeFrame: 6 months after intervention
measure: Change from HDL-cholesterol at 6 months
timeFrame: 6 months after intervention
measure: Change from LDL-cholesterol at 6 months
timeFrame: 6 months after intervention
measure: Change from Triglycerides at 6 months
timeFrame: 6 months after intervention
measure: Change from Total Cholesterol at 6 months
timeFrame: 6 months after intervention
measure: Change from systolic and diastolic blood pressure at 6 months
timeFrame: 6 months after intervention
measure: Change calorie intake at 6 months
timeFrame: 6 months after intervention
measure: Change of Body mass index at 6 months
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Pradana Soewondo, Prof
role: PRINCIPAL_INVESTIGATOR
References: