IDI-1 Study

Version 3.2
August 2013

Protocol

Improving Diabetes in Indonesia (IDI-1) study:

Evaluation of the status of diabetes care before and after a physician training
programe in public health centers in Indonesia

Observational study

A Project by PERKENI and Steno

IDI-1 Study
Version 3.2
August 2013

Introduction

Diabetes is becoming a disease with large number of patient nowadays and still increasing. A comprehensive approach is needed to prevent the
disease, as well as giving proper diagnosis and treatment to the patient. Therefore, PERKENI in collaborations with Steno Diabetes Center has
developed educational material to be used by PERKENI in a workshop program to increase knowledge and skill of physicians in identifying and
treating patient with diabetes. This project is intended to evaluate the outcomes of an educational intervention aimed at training internists and
primary health care physicians across Indonesia. With this evaluation project, the objective behaviour result can be measured and verify, as well
as the needs of program improvement, if any, in the future.
2

2.1

Objectives and endpoints

Objectives
1
2
3

2.2

To assess gain in knowledge and change in attitude in the short term, before and after a physician training programme in public
health centers in Indonesia.
To assess change in working processes in the medium term through a self-assessment form on Diabetes Practice Competence.
To evaluate the status of diabetes care using patient data to analyse the primary and secondary endpoints shown below in the long
term, before and after a physician training programme in public health centers in Indonesia.

Endpoints

The difference in below indicators between the two time points of data collection
Primary Endpoints
1. Change in KA (knowledge and attitude ) Evaluation of Diabetes training in clinic/hospital (before and after training test)
2. Change in number of HbA1c examinations performed in the clinic(before and after 1 year of training) per number of patients or change in
number of FBG/PPBG performed in the clinic per number of patients
3. Fulfilling criteria for more than 2 out 6 indicators (would be considered positive change)
3.1. Performing LDL cholesterol examination or performing Total cholesterol examination
3.2. Annual screening for albuminuria (once a year examination of urine albumin)
3.3. BP measurementat patient visit
3.4. Feet examination (once a year examination of feet)
3.5. Consult referal for eye examination and complications(once a year examination of eye)
3.6. Consult inquiry for cardiac examination and complications
Secondary endpoints
1. Proportion of patients with recorded numbers/examination findings available for bodyweight
2. Proportion of patients who are overweight (BMI 23) or obese (BMI 25) or normal
3. Proportion of patients with hypertension
4. Proportion of patients with dyslipidemia
5. Proportion of patients with albuminuria
6. Proportion of patients with retinopathy
7. Proportion of patients with foot symptoms and/or ulcer
8. Proportion of patients with peripheral neuropathy
9. Proportion of patients stroke
10. Proportion of patients with cardiovascular disease
Indicators of treatment practice
1. Proportion of patient on LSM (lifestyle modification)
2. Proportion of patients on OADs
3. Proportion of patients on Insulin with or without OADs
4. Proportion of patients on antihypertensive drugs
5. Proportion of patients on lipid lowering drugs
6. Proportion of patients on aspirin or blood thinner agents

Study design

The study is a observational, multi-centre, open-label, non-randomised prospective study. Patients with diabetes diagnosed for a minimun of one
year,engaged in routine diabetes care in internist- and primary care physician-run government health clinics in Indonesia are eligible. Each
participant physician will collect data from 20 consecutive patients of type 2 diabetes from the out-patient clinic before the training programme.
The patients will be selected within four weeks before the training program, selecting 5 patients per week, either the first patient per day, or if
diabetes patients are only seen once a week, the first five consecutive diabetes patients of the day. The participating physician will be 60 GPs and
35 Internist. A similar exercise is repeated 52-weeks after completion of the training program.

IDI-1 Study
Version 3.2
August 2013

To evaluate the impact of the course data collection would be both quantitative and qualitative. It would follow levels 1-5 of Belfields
adaptation of the Kirkpatricks evaluation program. (2001)
Level 1 examines the outcome of the course by studying the endpoints mentioned above using patient data records.
Level 2 the self-assessment on Diabetes Practice Competence form collected at the beginning of the program and then again after 6 months.
Level 3 examines the participants true gain in Knowledge, attitudes and skills (KAS) using a validated pre and post-test identical questionnaires
conducted at the beginning and the end of the training program.
Level 4 captures anonymously participants reactions on how they liked the course using a likert scale and open ended questions at the end of the
training program.
Level 5 captures the number of participants attending the training program using a response rate
All the instruments to be used for this evaluation have been specially designed, piloted and validated for feasibility before being introduced.
All subjects are to be includedafter taking informed consent as per the local regulations.
4
Study population
Participant physicians are engaged in routine diabetes care in internist- and primary care physician-run government health clinics in Indonesia
Planned number of patients to be included: 20 patients during each time point of data collection separated by 52weeks
Planned study period: The study will be done following all training programmes over a 1-year period from Q3-2013 to Q1-2015
Planned first subject complete first evaluation form : Q3-2013
Planned last subject complete second evaluation form: Q1-201
5
Safety reporting
Participant physicians will report on adverse drug reactions reported by patients according to local health regulations
6

Statistics

Sample size calculation is done. To study the different levels and primary and secondary endpoints appropriate inferential statistical tests will be
used. Studies analysing level 2-4 uses paired data while level 1 uses unpaired data.
Endpoint 1:
Assuming a mean evaluation of 3.0 before changed to 3.5 i.e. change of 0.5 (SD: 1.0) a significant change will be detected if N=74 clinics.
Significance level: 5% and power: 85%.
Taking an expected dropout rate of 15% into account 85 clinics are needed.
Endpoint 2:
Assuming a mean HbA1c in the patients of 7.9 % (SD: 2.0) (Ref: DiabCare Indonesia) reduced to 7.4% (SD: 2.0) i.e. Change -0.5%. Assuming
significance level of 5% and Power of 85%. 900 evaluable (incl. HbA1c measures) patients are needed in total 450 at each timepoint (before
and after). Assuming only 50% have an HbA1c measurement or not applicable for the analyses 900 patients must be enrolled at each timepoint.
Thus 20 patients per clinic from the 85 clinics enrolled for level 1.
7
Ethics
This study will be conducted with Ethical Clearance from Health Research Ethics Committee Faculty of Medicine University of Indonesia Cipto
Mangunkusumo Hospital. The study will be conducted in accordance with the Declaration of Helsinki, Ethical Principles for Medical Research
Involving Human Patients and the Guidelines for GoodPharmacoepidemiological Practice (GPP).
Informed consent will be taken before the subject is recruited in this study.
8

Clinical study report

PERKENIand Steno will develop joint reports. Steno would be responsible for preparing the report on levels 2-5 of the Belfields adaptation of
the Kirkpatrick method, while PERKENI would be responsible for reporting the Level 1 endpoint of the study.
9

Publications

The publications will be prepared by both PERKENI and Steno.

The information obtained during the conduct of this study is considered confidential and will be used by PERKENI and Steno for suggesting
improvements in educational interventions aimed at internists and primary care physicians engaged in diabetes care in Indonesia.

IDI-1 Study
Version 3.2
August 2013

Timeline for IDI -1 Study

10

Time table
Activities
Workshop
Prior to the training
program
(Level 1)
At start of training
(Level 2)
At the end of training
program
(level 3,4,5)
After 6 months of
training
(level 2)
After 1 year of training
(level 1)

Sept

Okt

Nov

Dec

Activities
June
Workshop
Prior to the training
program
(Level 1)
At start of training
(Level 2)
At the end of training
program
(level 3,4,5)
After 6 months of
training
(level 2)
After 1 year of training
(level 1)

July

Aug

2013/2014
Jan

Feb

Mar

Apr

Mei

2014
Sept

Oct

Nov

Dec

Appendix 1
Study budget
Items

Unit

Total cost

IDI-1 Study
Version 3.2
August 2013

Principle Investigator fee

Staff
Participant fee
Printing materials
(questionairre, photocopies,
stationary)
Postage/courrier
Ethical committee fee
Total

1
1
95
1

IDR 3,000,000
IDR 1,000,000
IDR 95,000,000
IDR 5,000,000

1
1

IDR 1,000,000
IDR 3,000,000
IDR 108,000,000