Type2 DiabetesNCT05090488
Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health Care
A study testing Personal Health Coaching and Diabetes Education in Group in people with Type2 Diabetes and Diabetes Mellitus, Type 2, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes, Diabetes Mellitus, Type 2, Endocrine System Diseases
- What is being tested?
- Personal Health Coaching and Diabetes Education in Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Dec 2020to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- >= 18 years old
- Willing to follow the research by signing an informed consent
Who cannot join
- Patients with cognitive disease (such as dementia)
- Patients with hearing or sight problem
- Unable to live independently on daily basis
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
University of Indonesia
Jakarta, DKI Jakarta
Em Yunir, PhD, +811161094, e.yunir@ui.ac.id
About this study
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
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
Read the 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
- Conditions
- Type2 Diabetes, Diabetes Mellitus, Type 2, Endocrine System Diseases, Nutritional and Metabolic Diseases, Glucose Metabolism Disorders (Including Diabetes Mellitus), Diabetes Mellitus
- Being tested
- Personal Health Coaching and Diabetes Education in Group
- Keywords
- Type 2 Diabetes Mellitus, Diabetes Education, Health Coaching
- Medical subject headings
- Diabetes Mellitus, Type 2, Endocrine System Diseases, Nutritional and Metabolic Diseases, Glucose Metabolism Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Health Coaching and Diabetes Education in GroupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Received Personal Health Coaching and Diabetes Education in Group | Experimental | 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 Receives: Behavioral: Personal Health Coaching and Diabetes Education in Group |
| Received Diabetes Education in Group | Active comparator | Diabetes education in group, with trained educator team from primary health care Receives: Behavioral: Personal Health Coaching and Diabetes Education in Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1C at 3 months and 6 months
HbA1C is indicator of glycemic control
Measured: Baseline, 3 and 6 months after intervention
Secondary outcomes (27)
Change from baseline fasting plasma glucose at 3 and 6 months
Blood glucose monitoring
Measured: Baseline, 3 and 6 months after intervention
Change from baseline serum lipid at 3 and 6 months
Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides
Measured: Baseline, 3 and 6 months after intervention
Change from baseline inflammatory marker at 3 and 6 months
Inflammatory marker used is hs-CRP (C-reactive protein)
Measured: Baseline, 3 and 6 months after intervention
Change from baseline body mass index
Body mass index described by kg/m2
Measured: Baseline, 3 and 6 months after intervention
Change from baseline waist circumference
Waist circumference measured by cm
Measured: Baseline, 3 and 6 months after intervention
Change from baseline body fat
Body fat measured by body impedance analysis
Measured: Baseline, 3 and 6 months after intervention
Change from baseline left ventricular mass index
Left ventricular mass index measured using standard formula and corrected by body surface area
Measured: Baseline, 6 months after intervention
Change from baseline left ventricular systolic function
Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography)
Measured: Baseline, 6 months after intervention
Change from baseline left atrial volume
Left atrial volume was measured through biplane area calculation in echocardiography procedure
Measured: Baseline, 6 months after intervention
Change from baseline right ventricular systolic function
Right ventricular systolic function was evaluated using TAPSE
Measured: Baseline, 6 months after intervention
change from baseline left ventricular diastolic function
LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016
Measured: Baseline, 6 months after intervention
Change from baseline electrocardiography pattern
Electrocardiography pattern was used to analyze cardiac rythm
Measured: Baseline and 6 months after intervention
Change from baseline heart rate variability
Heart rate variability was measured using ECG Holter examination
Measured: Baseline and 6 months after intervention
Baseline visual acuity
Visual acuity was measured by Peek acuity chart application using WHO classification
Measured: Baseline
Baseline lens haziness
Lens haziness was evaluated using shadow test
Measured: Baseline
Baseline retina examination
Retina was examined using funduscopic photography
Measured: Baseline
Baseline intraocular pressure
Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy
Measured: Baseline
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
Measured: Baseline, 3 and 6 months after intervention
Change from baseline peripheral autonomic neuropathy
Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin)
Measured: Baseline, 3 and 6 months after intervention
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)
Measured: Baseline, 3 and 6 months after intervention
Change from baseline peripheral arterial disease
Peripheral arterial disease was diagnosed through ankle brachial index measurement
Measured: Baseline, 3 and 6 months after intervention
Change from baseline renal function
Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data
Measured: Baseline and 6 months after intervention
Change from baseline albuminuria
Albuminuria was measured by albumin creatinine ratio
Measured: Baseline and 6 months after intervention
Change from baseline mean calorie intake
Evaluation of mean calorie intake using food record data
Measured: Baseline, 3 and 6 months after intervention
Change from baseline global physical activity
Global physical activity was evaluated by global physical activity questionnaire
Measured: Baseline, 3 and 6 months after intervention
Change from baseline medication adherence
Medication adherence was measured by Morisky Medication Adherence Scale (MMAS)
Measured: Baseline, 3 and 6 months
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).
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start14 Dec 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia
- Responsible party
- Principal investigator, Em Yunir, Universitas Indonesia
- Investigators
- Em Yunir, PhD, Principal investigator, Divisi Metabolik Endokrin IPD FKUI RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090488
- Sponsor's protocol ID
- Health Coaching Jakarta
- Status last verified
- Apr 2022
- First submitted
- 11 Feb 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05090488
- Acronym / sponsor ID
- Health Coaching Jakarta
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received Personal Health Coaching and Diabetes Education in Group | Experimental | Behavioral: Personal Health Coaching and Diabetes Education in GroupHealth 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 |
| Received Diabetes Education in Group | Active comparator | Behavioral: Personal Health Coaching and Diabetes Education in GroupDiabetes education in group, with trained educator team from primary health care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes Mellitus
- >= 18 years old
- Willing to follow the research by signing an informed consent
Key exclusion criteria (3 listed)
- Patients with cognitive disease (such as dementia)
- Patients with hearing or sight problem
- Unable to live independently on daily basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Health Coaching and Diabetes Education in GroupHealth 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 | Behavioural | Received Diabetes Education in Group, Received Personal Health Coaching and Diabetes Education in Group |
Primary outcome
Change from baseline HbA1C at 3 months and 6 months
Time frame: Baseline, 3 and 6 months after intervention
HbA1C is indicator of glycemic control
27 secondary outcomes
Change from baseline fasting plasma glucose at 3 and 6 months
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline serum lipid at 3 and 6 months
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline inflammatory marker at 3 and 6 months
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline body mass index
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline waist circumference
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline body fat
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline left ventricular mass index
Time frame: Baseline, 6 months after intervention
Change from baseline left ventricular systolic function
Time frame: Baseline, 6 months after intervention
Change from baseline left atrial volume
Time frame: Baseline, 6 months after intervention
Change from baseline right ventricular systolic function
Time frame: Baseline, 6 months after intervention
change from baseline left ventricular diastolic function
Time frame: Baseline, 6 months after intervention
Change from baseline electrocardiography pattern
Time frame: Baseline and 6 months after intervention
Change from baseline heart rate variability
Time frame: Baseline and 6 months after intervention
Baseline visual acuity
Time frame: Baseline
Baseline lens haziness
Time frame: Baseline
Baseline retina examination
Time frame: Baseline
Baseline intraocular pressure
Time frame: Baseline
Change from baseline peripheral sensory neuropathy
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline peripheral autonomic neuropathy
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline peripheral motor neuropathy
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline peripheral arterial disease
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline renal function
Time frame: Baseline and 6 months after intervention
Change from baseline albuminuria
Time frame: Baseline and 6 months after intervention
Change from baseline mean calorie intake
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline global physical activity
Time frame: Baseline, 3 and 6 months after intervention
Change from baseline medication adherence
Time frame: Baseline, 3 and 6 months
Change from baseline quality of life
Time frame: Baseline, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Em Yunir, PhD principal investigator
Divisi Metabolik Endokrin IPD FKUI RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Health Coaching and Diabetes Education in Group in people with Type2 Diabetes and Diabetes Mellitus, Type 2, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Em Yunir, PhD (+811161094, e.yunir@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline HbA1C at 3 months and 6 months (time frame: Baseline, 3 and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.