Clinical trial NCT05090488: Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health Care
Official title: The Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Patients at Jakarta Primary Health Care: Role on Metabolic Control, Diabetes Complications, Inflammatory Marker, Behavior Changes, and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes
Diabetes Mellitus, Type 2
Endocrine System Diseases
Nutritional and Metabolic Diseases
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Diabetes Education
Health Coaching
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
First posted: 2021-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 Diabetes Mellitus is a chronic disease with increasing incidence globally. It needs a comprehensive and continuous management approach that includes five pillars: education, nutritional management, physical activity, pharmacological treatment, and monitoring. To achieve good glycemic control, prevention of complications, and good quality of life as diabetes management goals, patients' capability to properly navigate diabetes management is a key. One evidence-based model to empower patients' self-management abilities is diabetes education and health coaching. Diabetes management at primary health care needs special concern since they play an important role in initial and continuing care for diabetes patients in the community. Therefore, the implementation of diabetes education and health coaching in primary health care is expected to improve the self-management abilities of people with diabetes

Detailed description: A randomized control trial, pre and post study involving 180 subjects randomized into 2 arms:

* Control : received education in group
* Intervention : received education group + personal health coaching Education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.

Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.

Laboratory examination, anthropometric measurement, echocardiography, electrocardiography, Heart Rate Variability measurement, diabetic eye screening, and questionnaire collected at baseline, 3 and 6 months after intervention

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* \>= 18 years old
* Willing to follow the research by signing an informed consent

Exclusion Criteria:

* Patients with cognitive disease (such as dementia)
* Patients with hearing or sight problem
* Unable to live independently on daily basis

Primary outcomes:
measure: Change from baseline HbA1C at 3 months and 6 months
timeFrame: Baseline, 3 and 6 months after intervention
Secondary outcomes:
measure: Change from baseline fasting plasma glucose at 3 and 6 months
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline serum lipid at 3 and 6 months
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline inflammatory marker at 3 and 6 months
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline body mass index
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline waist circumference
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline body fat
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline left ventricular mass index
timeFrame: Baseline, 6 months after intervention
measure: Change from baseline left ventricular systolic function
timeFrame: Baseline, 6 months after intervention
measure: Change from baseline left atrial volume
timeFrame: Baseline, 6 months after intervention
measure: Change from baseline right ventricular systolic function
timeFrame: Baseline, 6 months after intervention
measure: change from baseline left ventricular diastolic function
timeFrame: Baseline, 6 months after intervention
measure: Change from baseline electrocardiography pattern
timeFrame: Baseline and 6 months after intervention
measure: Change from baseline heart rate variability
timeFrame: Baseline and 6 months after intervention
measure: Baseline visual acuity
timeFrame: Baseline
measure: Baseline lens haziness
timeFrame: Baseline
measure: Baseline retina examination
timeFrame: Baseline
measure: Baseline intraocular pressure
timeFrame: Baseline
measure: Change from baseline peripheral sensory neuropathy
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline peripheral autonomic neuropathy
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline peripheral motor neuropathy
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline peripheral arterial disease
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline renal function
timeFrame: Baseline and 6 months after intervention
measure: Change from baseline albuminuria
timeFrame: Baseline and 6 months after intervention
measure: Change from baseline mean calorie intake
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline global physical activity
timeFrame: Baseline, 3 and 6 months after intervention
measure: Change from baseline medication adherence
timeFrame: Baseline, 3 and 6 months
measure: Change from baseline quality of life
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University of Indonesia
state: DKI Jakarta
Study officials:
affiliation: Divisi Metabolik Endokrin IPD FKUI RSCM
name: Em Yunir, PhD
role: PRINCIPAL_INVESTIGATOR
References: