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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05090488
Other study ID # Health Coaching Jakarta
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2020
Est. completion date June 2023

Study information

Verified date April 2022
Source Indonesia University
Contact Em Yunir, PhD
Phone +811161094
Email e.yunir@ui.ac.id
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Personal Health Coaching and Diabetes Education in Group
Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care

Locations

Country Name City State
Indonesia University of Indonesia Jakarta DKI Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Indonesia University Provincial Health Services Authority

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline HbA1C at 3 months and 6 months HbA1C is indicator of glycemic control Baseline, 3 and 6 months after intervention
Secondary Change from baseline fasting plasma glucose at 3 and 6 months Blood glucose monitoring Baseline, 3 and 6 months after intervention
Secondary Change from baseline serum lipid at 3 and 6 months Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides Baseline, 3 and 6 months after intervention
Secondary Change from baseline inflammatory marker at 3 and 6 months Inflammatory marker used is hs-CRP (C-reactive protein) Baseline, 3 and 6 months after intervention
Secondary Change from baseline body mass index Body mass index described by kg/m2 Baseline, 3 and 6 months after intervention
Secondary Change from baseline waist circumference Waist circumference measured by cm Baseline, 3 and 6 months after intervention
Secondary Change from baseline body fat Body fat measured by body impedance analysis Baseline, 3 and 6 months after intervention
Secondary Change from baseline left ventricular mass index Left ventricular mass index measured using standard formula and corrected by body surface area Baseline, 6 months after intervention
Secondary Change from baseline left ventricular systolic function Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography) Baseline, 6 months after intervention
Secondary Change from baseline left atrial volume Left atrial volume was measured through biplane area calculation in echocardiography procedure Baseline, 6 months after intervention
Secondary Change from baseline right ventricular systolic function Right ventricular systolic function was evaluated using TAPSE Baseline, 6 months after intervention
Secondary change from baseline left ventricular diastolic function LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016 Baseline, 6 months after intervention
Secondary Change from baseline electrocardiography pattern Electrocardiography pattern was used to analyze cardiac rythm Baseline and 6 months after intervention
Secondary Change from baseline heart rate variability Heart rate variability was measured using ECG Holter examination Baseline and 6 months after intervention
Secondary Baseline visual acuity Visual acuity was measured by Peek acuity chart application using WHO classification Baseline
Secondary Baseline lens haziness Lens haziness was evaluated using shadow test Baseline
Secondary Baseline retina examination Retina was examined using funduscopic photography Baseline
Secondary Baseline intraocular pressure Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy Baseline
Secondary Change from baseline peripheral sensory neuropathy Peripheral sensory neuropathy was measured using combination of subjective manifestation, 10 g Simme Weinstein monofilament and 128 Hz tuning fork Baseline, 3 and 6 months after intervention
Secondary Change from baseline peripheral autonomic neuropathy Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin) Baseline, 3 and 6 months after intervention
Secondary Change from baseline peripheral motor neuropathy Peripheral motor neuropathy was seen visually by objective examination (changes in the shape of fingers, muscle atrophy, or bone protrusions) Baseline, 3 and 6 months after intervention
Secondary Change from baseline peripheral arterial disease Peripheral arterial disease was diagnosed through ankle brachial index measurement Baseline, 3 and 6 months after intervention
Secondary Change from baseline renal function Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data Baseline and 6 months after intervention
Secondary Change from baseline albuminuria Albuminuria was measured by albumin creatinine ratio Baseline and 6 months after intervention
Secondary Change from baseline mean calorie intake Evaluation of mean calorie intake using food record data Baseline, 3 and 6 months after intervention
Secondary Change from baseline global physical activity Global physical activity was evaluated by global physical activity questionnaire Baseline, 3 and 6 months after intervention
Secondary Change from baseline medication adherence Medication adherence was measured by Morisky Medication Adherence Scale (MMAS) Baseline, 3 and 6 months
Secondary Change from baseline quality of life Quality of life was evaluated by EuroQol five-dimensional questionnaire. This questionnaire evaluates 5 dimensions of life. Each dimension scores 1-5 (1 means no problem and 5 means extreme problems). Baseline, 3 and 6 months
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