Diabetes Type 2NCT04289818
The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
A study testing Health Coaching in people with Diabetes Type 2, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Health Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2018to 31 Mar 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- T2DM patients
- aged 30-60 years old
- HbA1C > 7.5% within the past 3 months
- able to write and read.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes
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.
Read the 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.
- Conditions
- Diabetes Type 2
- Being tested
- Health Coaching
- Keywords
- Diabetes Mellitus, Health coaching
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingOther
Health Coaching as face to face with a coach
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Conventional Education Class |
| Coaching | Experimental | Health Coaching Receives: Other: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline HbA1c at 3 months
Glycemic Control
Measured: 3 month after intervention
Change from Baseline HbA1c at 6 months
Glycemic Control
Measured: 6 month after intervention
Secondary outcomes (19)
Change from Baseline Fasting Plasma Glucose at 3 months
Glycemic Control
Measured: 3 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 3 months
Glycemic control
Measured: 3 months after intervention
Change from HDL-cholesterol at 3 months
Diabetes mellitus control
Measured: 3 months after intervention
Change from LDL-cholesterol at 3 months
Diabetes mellitus control
Measured: 3 months after intervention
Change from Triglycerides at 3 months
diabetes mellitus control
Measured: 3 months after intervention
Change from Total Cholesterol at 3 months
Diabetes mellitus control
Measured: 3 months after intervention
Change of Body mass index at 3 months
Diabetes mellitus control
Measured: 3 month after intervention
Change calorie intake at 3 months
life style parameter
Measured: 3 month after intervention
International Physical Activity Questionnaire (IPAQ) questionnaire
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
Measured: baseline, 3 month and 6 months after intervention
EQ-5D quality of life questionnaire
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.
Measured: baseline, 3 month and 6 months after intervention
Change from Baseline Fasting Plasma Glucose at 6 months
Glycemic Control
Measured: 6 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 6 months
Glycemic Control
Measured: 6 months after intervention
Change from HDL-cholesterol at 6 months
diabetes mellitus Control
Measured: 6 months after intervention
Change from LDL-cholesterol at 6 months
diabetes mellitus Control
Measured: 6 months after intervention
Change from Triglycerides at 6 months
diabetes mellitus Control
Measured: 6 months after intervention
Change from Total Cholesterol at 6 months
diabetes mellitus Control
Measured: 6 months after intervention
Change from systolic and diastolic blood pressure at 6 months
diabetes mellitus Control
Measured: 6 months after intervention
Change calorie intake at 6 months
life style parameter
Measured: 6 months after intervention
Change of Body mass index at 6 months
diabetes mellitus control
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Feb 2018
- Primary completion31 Aug 2018
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Universitas Indonesia
- Investigators
- Pradana Soewondo, Prof, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289818
- Sponsor's protocol ID
- PS002
- Status last verified
- Nov 2022
- First submitted
- 10 Feb 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes
- ClinicalTrials.gov ID
- NCT04289818
- Acronym / sponsor ID
- PS002
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes Mellitus, Health coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 28 Feb 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Conventional Education Class |
| Coaching | Experimental | Other: Health CoachingHealth Coaching |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- T2DM patients
- aged 30-60 years old
- HbA1C > 7.5% within the past 3 months
- able to write and read.
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Health CoachingHealth Coaching as face to face with a coach | Other | Coaching |
Primary outcome
Change from Baseline HbA1c at 3 months
Time frame: 3 month after intervention
Glycemic Control
Change from Baseline HbA1c at 6 months
Time frame: 6 month after intervention
Glycemic Control
19 secondary outcomes
Change from Baseline Fasting Plasma Glucose at 3 months
Time frame: 3 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 3 months
Time frame: 3 months after intervention
Change from HDL-cholesterol at 3 months
Time frame: 3 months after intervention
Change from LDL-cholesterol at 3 months
Time frame: 3 months after intervention
Change from Triglycerides at 3 months
Time frame: 3 months after intervention
Change from Total Cholesterol at 3 months
Time frame: 3 months after intervention
Change of Body mass index at 3 months
Time frame: 3 month after intervention
Change calorie intake at 3 months
Time frame: 3 month after intervention
International Physical Activity Questionnaire (IPAQ) questionnaire
Time frame: baseline, 3 month and 6 months after intervention
EQ-5D quality of life questionnaire
Time frame: baseline, 3 month and 6 months after intervention
Change from Baseline Fasting Plasma Glucose at 6 months
Time frame: 6 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 6 months
Time frame: 6 months after intervention
Change from HDL-cholesterol at 6 months
Time frame: 6 months after intervention
Change from LDL-cholesterol at 6 months
Time frame: 6 months after intervention
Change from Triglycerides at 6 months
Time frame: 6 months after intervention
Change from Total Cholesterol at 6 months
Time frame: 6 months after intervention
Change from systolic and diastolic blood pressure at 6 months
Time frame: 6 months after intervention
Change calorie intake at 6 months
Time frame: 6 months after intervention
Change of Body mass index at 6 months
Time frame: 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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.
Pradana Soewondo, Prof principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Diabetes 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HbA1c at 3 months (time frame: 3 month after intervention). The study lists 2 primary outcomes in all. 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 2 Nov 2022.