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Trial registered on ANZCTR


Registration number
ACTRN12621001128886
Ethics application status
Approved
Date submitted
24/05/2020
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Date results provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of pharmacist involvement in Diabetes Medication Therapy Adherence Program (DMTAC) on the clinical outcomes of diabetes in two different hospitals of Kedah state Malaysia
Scientific title
Effect of pharmacist involvement in Diabetes Medication Therapy Adherence Program (DMTAC) on the clinical outcomes in type 2 diabetes mellitus - a multicentre randomised control trial
Secondary ID [1] 301360 0
The current study was registered on the National Medical Research Register (NMRR) Malaysia with the registration number NMRR-17-2381-38042
Universal Trial Number (UTN)
U1111-1252-5588
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 317590 0
Condition category
Condition code
Metabolic and Endocrine 315671 315671 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Ministry of Health Malaysia has provided the protocol far diabetic medication therapy adherence clinic as a informational material for pharmacist intervention. The length of each visit is 30 to 40 minutes. Whereas the time between visits is two to three months depending on the patient condition. All study visits will be conducted over a 10- 12 month period.
The brief description off provided material was as follows:
First Module of Patient Education (for visit 1 and 2)
The first educational module covers the following education for the patients
A basic outline of diabetes (signs and symptoms, complications, etc.). Therapeutic goals, especially blood glucose (FBG and HbA1c, etc.). A detailed discussion with the diabetic patient on use/adverse effects of medicines (insulin and hypoglycaemic agents). Self-monitoring of blood glucose levels by patients - how, when, why etc. (if applicable). Signs and symptoms of hypoglycaemia and hyperglycaemia, how to manage at home, sick day management and sequence of actions to be taken. Storage of anti-diabetic medications at home. Explanation to the patient concerns
Second module of patient education (for visit 3 and 4)
The second module covers the following education for the patients
Cardiovascular education of the patients (Lipid profile, blood pressure, peripheral vascular disease, and goals). Benefits for achieving target blood glucose levels and risks for not control or poor control of blood glucose levels. Explanation on medication use and adverse effects of medicines to the patients (anti-hypertensives, anti-platelets, and anti-cholesterol). Explanation to the patient concerns.
Third module of patient education (for visit 5 and 6)
The third educational module covers the following education for the patients
Benefits of exercise. Reminder about the hypoglycaemic reactions. Basic important nutritions. Introduction to the benefits of quit smoking. Introduction and explanation about the health benefits of quit smoking. Explanation to the patient concerns
Fourth module of patient education (for visit 7 and 8)
The fourth educational module covers following education for the patients
Detailed discussion on diabetes complications (macrovascular and microvascular complications). Prevention, recognition, and treatment of diabetic complications. Explanation about foot care. Explanation to the patient concerns. Benefits of exercise

Well trained clinical pharmacist appointed by Ministry of Health Malaysia will deliver the intervention. The mode of delivery is face to face and it will be provided individually to the patients. The approximate length for each visit was one to two months depending on the patient condition And One module of the protocol was covered in two visits. The location of the intervention occurs in the diabetes medication therapy adherence clinics under the clinical services in hospitals- In Malaysia in all the tertiary hospitals diabetes medication therapy adherence clinics are running by the help of well-trained clinical pharmacist besides the endocrinology clinics. Diabetes medication adherence clinics in Malaysia have their own adherence scale to measure the adherence of the patients.
Intervention code [1] 317658 0
Lifestyle
Intervention code [2] 317659 0
Behaviour
Comparator / control treatment
In the current study, the patients belong to usual care from Diabetic clinics were categorized as the control group. In the control group, the patient will come to hospital and after registration will see the physician and after that will get the medicine from pharmacy and go back home. No education given to the patient.
Control group
Active

Outcomes
Primary outcome [1] 326145 0
To evaluate the impact of pharmacist intervention on clinical outcomes in the form of HbA1c of diabetes mellitus in diabetic patients.

Hospital laboratories determined the HbA1c of patients in both study groups as both the selected study hospitals belonged to the government; thus, the laboratory investigations and all medications were provided by the government of Malaysia under the Ministry of Health Malaysia. All the laboratory investigations and medicines are free of cost to the patients. The researchers only collected the details of data in the form of information from the patients. Additionally, the study tool also carried various signs and symptoms list related to diabetic neuropathy to evaluate diabetic complications in selected patients.
Timepoint [1] 326145 0
Approximately one year after the patient recruitment
Secondary outcome [1] 390240 0
To evaluate the impact of pharmacist intervention on patient-reported quality of life in diabetic patients. The patient-reported quality of life will be assessed by using the EQ-5D 5L questionnaire. The approval to use it was already taken from concerned authortories.
Timepoint [1] 390240 0
Approximately one year after the patient recruitment
Secondary outcome [2] 390241 0
To evaluate the impact of pharmacist intervention on the direct cost of treatment (hospital bearing) in diabetic patients. The drug (used in this study) price list is taken from the hospital with approval. This outcome will be assessed one-on-one semi-structured interview to see which drug and what quantity of the drug was given to the patient.
Timepoint [2] 390241 0
Approximately one year after the patient recruitment
Secondary outcome [3] 390242 0
To evaluate the impact of pharmacist intervention on the progression of signs and symptoms of diabetic complications in diabetic patients. This outcome will be assessed one-on-one semi-structured interview with the help of a Data collection form where the different signs and symptoms of Diabetic foot, Diabetic Retinopathy, Diabetic Nephropathy, and Diabetic Neuropathy will be there. On every visit, these sign and symptoms will be asked from the patient in a one-on-one semi-structured interview
Timepoint [3] 390242 0
Approximately one year after the patient recruitment

Eligibility
Key inclusion criteria
Patients who are having Diabetes mellitus since a minimum of 5 years and HbA1c more than 8.0% and receiving medicine from any selected hospital. Total 200 patients required in each selected hospital and from those 200 patients 100 will be taken from Diabetic clinics and 100 will be taken from DMTAC clinics
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant diabetic patients, HIV / cancer patients, Incomplete Patient Record,Children with CKD, Newly diagnosed patients

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer (Microsoft Excel)
The patient hospital identity numbers were entered in Microsoft Excel and Randomization was carried out
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation:
Sample size estimation was calculated using two population means formulae (Lemeshow, Hosmer, Klar, Lwanga, & organization 1990). Prior data indicate that the mean adherence for the control group was 5.98 (SD 1.5) and the mean for the intervention group was 6.77 (SD 1.76). Mean Hba1c for the control group was 9.26 (SD 1.61) and interventional group 8.47 (SD 1.61). QoL for the control group was 77.12 (SD 11.52) while 82.45 (SD 10.26) for the intervention group. Thus, a minimum sample size of 65 samples per group to be able to reject the null hypothesis with a probability of 0.8. The type I error probability associated with this test of this null hypothesis is 0.05. The independent t-test statistic will be used to evaluate this null hypothesis. With an additional 20% dropout rate, the sample size is about 80 samples per group.
Note:
The sample size was calculated using the previous data from Butt, Mubashra, et al. (2016) to compare the mean of HbA1c between the intervention and control group. A total of 65 patients in each study group were needed to detect the difference of 0.79% (8.47% versus 9.26% HBA1c) with 80% certainty (power) and using an alpha level of 0.05 and SD is s = 1.61

Formula
This calculator uses the following formula for the sample size (n):
n = (Za/2+Zß)2 *2*s2 / d2,

where Za/2 is the critical value of the Normal distribution at a/2 (e.g. for a confidence level of 95%, a is 0.05 and the critical value is 1.96), Zß is the critical value of the Normal distribution at ß (e.g. for a power of 80%, ß is 0.2 and the critical value is 0.84), s2 is the population variance, and d is the difference you would like to detect.
Whereas and µ1 is 9.26 (mean HbA1c of Mean Hba1c for control group was 9.26 (SD 1.61) = µ1 and interventional group 8.47 (SD 1.61) = µ2

So,
d = (µ1-µ2)

= (9.26 – 8.47)

= (0.79)


So Sample size (n) will be as follows:

n = (1.96+0.84)2 *2*(1.61)2 / (0.79)2

n = 65

n = 65 + 20% drop out ==> about 80 for each group

To see more significance the sample size was made 100 for each group i.e. Intervention group and Control group
.
Intervention group sample size = 100
Control group sample size = 100
Total sample size for each hospital = 200
For two hospitals = 400 (200 control group and 200 intervention group)


Statistical Analysis Plan and method of data analysis:
The data analysis will be done using SPSS version 22. Descriptive data will be expressed as mean ± standard deviation (SD). Kolmogorov-Smirnov test (KS-test) and Shapiro-Wilk Test will be applied to the collected data to check the normality of data.
If the normality of data shows that it is normally distributed then the independent t-test statistic will be used to evaluate the null hypothesis. One-way ANOVA will be used for analysis. Kruskal-Wallis or Mann Whitney U will be used for non-normally distributed data. Categorical data will be analyzed using Chi-square or Fisher‘s exact test. A value of P < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Safety concerns
Date of first participant enrolment
Anticipated
Actual
3/09/2018
Date of last participant enrolment
Anticipated
Actual
6/12/2018
Date of last data collection
Anticipated
Actual
2/03/2020
Sample size
Target
400
Accrual to date
Final
299
Recruitment outside Australia
Country [1] 22570 0
Malaysia
State/province [1] 22570 0
Kedah

Funding & Sponsors
Funding source category [1] 305800 0
Self funded/Unfunded
Name [1] 305800 0
Muhammad Zahid Iqbal
Country [1] 305800 0
Malaysia
Primary sponsor type
Individual
Name
Muhammad Zahid Iqbl
Address
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
Country
Malaysia
Secondary sponsor category [1] 306238 0
Individual
Name [1] 306238 0
Amer Hayat Khan
Address [1] 306238 0
Department of Clinical Pharmacy, School of Pharmaceutical Sciences, 11800 Universiti Sains Malaysia, Pulau Pinang
Country [1] 306238 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306071 0
Medical Research & Ethics Committee (MREC), Ministry of Health Malaysia
Ethics committee address [1] 306071 0
Ethics committee country [1] 306071 0
Malaysia
Date submitted for ethics approval [1] 306071 0
13/04/2018
Approval date [1] 306071 0
21/08/2018
Ethics approval number [1] 306071 0
KKM/NIHSEC/ P18-1307 (13)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102598 0
Dr Muhammad Zahid Iqbal
Address 102598 0
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
Country 102598 0
Malaysia
Phone 102598 0
+60169729584
Fax 102598 0
Email 102598 0
[email protected]
Contact person for public queries
Name 102599 0
Muhammad Zahid Iqbal
Address 102599 0
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
Country 102599 0
Malaysia
Phone 102599 0
+60169729584
Fax 102599 0
Email 102599 0
[email protected]
Contact person for scientific queries
Name 102600 0
Muhammad Zahid Iqbal
Address 102600 0
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
Country 102600 0
Malaysia
Phone 102600 0
+60169729584
Fax 102600 0
Email 102600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The individual participant data collected during the trial, after de-identification; individual participant data underlying published results only will be shared -

Unpublished data will not be shared
When will data be available (start and end dates)?
Data will be available after results analysis
in January 2021 to January 2024
for 3 years
Available to whom?
only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor, etc.
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal, for IPD meta-analyses, etc
How or where can data be obtained?
access subject to approvals by Principal Investigator (Email: [email protected]), etc.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12219Informed consent form    379885-(Uploaded-23-06-2021-15-50-16)-Study-related document.pdf
12220Ethical approval    379885-(Uploaded-23-06-2021-15-51-34)-Study-related document.pdf



Results publications and other study-related documents

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