This research was done at the primary care centre, Klinik Kesihatan Jenjarom which is located within the district of Kuala Langat. The samples chosen are adult age 30 and above and are receiving treatment from the clinic.
2.2 STUDY DESIGN
This study was a randomized prospective controlled study. The patients were randomly divided into two groups, the odd number group and the even number group. Both groups were assessed on their knowledge and adherence using the Modified Morisky scale and DFIT form. Then, one group (odd number group) was assigned to usual care without any intervention or counseling and the other group (even number group) was assigned for intervention or counseling. After an interval time of 30 days where the patients came back to refill their medication or for follow up, the patients were contacted and re-assessed again using the Modified Morisky scale and DFIT form. By using both methods, the combined results would then provide more information regarding the patients' medications adherence and knowledge. The fasting blood glucose (FBS) of the patients were taken in both interview session and were used to compare and tally with the medication adherence score obtained through Modified Morisky scale and DFIT form.
Using Morisky Scale & DFIT to assess the patient's adherence, knowledge.
Pharmacist's Intervention & Counseling
Using Morisky Scale & DFIT to assess the patient's adherence, knowledge.
Figure 2.1 Study Profile 1
2.3 MATERIAL PREPARATION
The materials needed for this research include the Modified Morisky form (Appendix I) the Dose, Frequency, Indication and Time (DFIT) Form English version (Appendix II) and Malay version (Appendix III).
2.4 SAMPLE SIZE CALCULATION
Calculation:
ss = Z 2 * (p) * (1-p)
c 2
= 1.962*(0.5)*(0.5)
0.052
= 384.16
Where:
Z = Z value (e.g. 1.96 for 95% confidence level)
p = percentage picking a choice, expressed as decimal (0.5 used for sample size needed)
c = confidence interval, expressed as decimal (e.g., .05 = ±5)
Correction to finite population
New Sample Size = ss
1 + (ss - 1)
Population
= 384.16
1 + (384.16 - 1)
1145
= 288 subjects
Number of sample size calculated = 288 subjects
2.5 DATA SOURCE
The studied samples were taken from the patients receiving treatments at the primary health care centre, Klinik Kesihatan Jenjarom.
2.6 DATA COLLECTION
2.6.1 Blood Glucose Level
The blood glucose level collected in this study was the fasting blood glucose (FBS). The categorization of the FBS was based on the standard that was used in the primary care centre which was according to the 2nd Asian-Pacific Type 2 Diabetes Policy Group. The FBS level was categorized into 3 groups, low (4.4 - 6.1 mmol/L), medium (6.2 - 7.0 mmol/L) and high (> 7.1 mmol/L).
2.6.2 Modified Morisky scale
The Morisky scale is a brief questionnaire in order to aid the practitioners in prospectively predicting patient's adherence to their medications. There are total of 6 questions to assess the adherence of the patient. Question 1, 2 and 6 which measure forgetfulness and carelessness are considered to be indicative of motivation and consequently impact the motivation aspects of adherence intention. Question 3, 4, and 5 which measure if patients stop medications and understand the long-term benefits of continued therapy, were considered to be indicative of knowledge and consequently impact the knowledge aspects of adherence intention.
2.6.3 DFIT form
The DFIT form was used to assess patients' compliance and also knowledge as well. The patients were asked on the dose, frequency, indication and time for each individual drug. Drug and frequency are to assess patients' compliance towards their medications where indication and time is to assess patients' knowledge on their drugs. A score of 0 was given if patients were unable to answer correctly and a score of 1 is given for every correct answer. The DFIT form was divided into DF, DFI and DFIT. During the first interview, the scores were recorded and this would be use to compare with the scores obtained during the follow up interview. If the scores shifted from DF to DFI and finally to DFIT, this indicates that there was an improvement in patient's adherence and knowledge.
2.6.4 Patient Interview
Patients were identified and selected according to the odd and even number division. Patients with the age more than 30 years old and with diabetes were selected to be interviewed. The Fasting Blood Glucose (FBS), gender, and race were recorded. Their medication lists were also recorded according to the patient's medical records. After that, patients were interviewed by following the steps:
Introduction and explanation on the purpose of the interview was done by providing the Patient Information Sheet (Appendix V) in both English and Malay version.
Patient's consent were obtained in both English and Malay version (Appendix VI)
Patients were interviewed using questions based on Morisky scale and DFIT form.
For the selected patients for pharmacist's intervention, a drug identification chart (DIC) (Appendix IV) was given to them.
End the interview by thanking the patient.
The interview was done in a suitable language such as Bahasa Melayu, Mandarin and English, based on patient's preference. The patients were interviewed in a comfortable area before being attended by the medical officers or medical assistants. The expected time for every interview was about 10 to 15 minutes. The involvement of patients in this research was voluntary. Patients were ensured of confidentiality regarding their information.
2.7 RESEARCH REGISTRATION
Research registration form (Appendix VII) was completed prior to data collection process. It was filled via online using the web link (www.nmrr.gov.my). The signatures of the Director of the institution (Dr. Nor Izzah Bt. Hj Ahmad Shauki) and Head of Department (Dr. Shuaita Bt. Mohd Nor @ Emran) were obtained in order to seek approval from the Clinical Research Centre (CRC). Then, the secretariat issued the NMRR ID as for the reference. The NMRR Registration ID for this study was NMRR-10-368-5652. Once the application was approved, it was automatically authorized by the Clinical Research Centre (CRC) and then certified to conduct the study at the institution. A computer-generated document issued by the Director of Clinical Research Centre, Dr. Lim Teck Onn (Appendix VIII).
2.7.1 Ethics Approval
The application form was sent to the Ethics Committee Bureau (JEPP) via online and revised for the proposal. With the permission from the Committee, the approval was obtained to conduct this study. The letter of approval (Appendix IX) was issued by the Ethics Committee Bureau as for the clearance of this study.
2.8 PATIENT SELECTION
Inclusion Criteria
Adult patients with age > 30, and receiving treatment from that primary care centre.
Exclusion Criteria
Patients who could not be contacted and poor in communication.
2.9 DATA ANALYSIS
The patients' knowledge and compliance were assessed based on their score obtained from the Morisky scale and DFIT forms. Microsoft Excel 2007 and the Statistical Package for the Social Sciences (SPSS) Statistics version 17.0 were used to tabulate results and generate graphs and charts.
