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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 information initially 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
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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
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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
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Universal Trial Number (UTN)
U1111-1252-5588
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus
317590
0
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Condition category
Condition code
Metabolic and Endocrine
315671
315671
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
317658
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Lifestyle
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Intervention code [2]
317659
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
326145
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Timepoint [1]
326145
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Approximately one year after the patient recruitment
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Secondary outcome [1]
390240
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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.
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Assessment method [1]
390240
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Timepoint [1]
390240
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Approximately one year after the patient recruitment
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Secondary outcome [2]
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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.
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Assessment method [2]
390241
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Timepoint [2]
390241
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Approximately one year after the patient recruitment
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Secondary outcome [3]
390242
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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
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Assessment method [3]
390242
0
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Timepoint [3]
390242
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Approximately one year after the patient recruitment
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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
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pregnant diabetic patients, HIV / cancer patients, Incomplete Patient Record,Children with CKD, Newly diagnosed patients
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
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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.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Safety concerns
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Date of first participant enrolment
Anticipated
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Actual
3/09/2018
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Date of last participant enrolment
Anticipated
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Actual
6/12/2018
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Date of last data collection
Anticipated
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Actual
2/03/2020
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Sample size
Target
400
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Accrual to date
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Final
299
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Recruitment outside Australia
Country [1]
22570
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Malaysia
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State/province [1]
22570
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Kedah
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Funding & Sponsors
Funding source category [1]
305800
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Self funded/Unfunded
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Name [1]
305800
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Muhammad Zahid Iqbal
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Address [1]
305800
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Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
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Country [1]
305800
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Malaysia
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Primary sponsor type
Individual
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Name
Muhammad Zahid Iqbl
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Address
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
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Country
Malaysia
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Secondary sponsor category [1]
306238
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Individual
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Name [1]
306238
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Amer Hayat Khan
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Address [1]
306238
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Department of Clinical Pharmacy, School of Pharmaceutical Sciences, 11800 Universiti Sains Malaysia, Pulau Pinang
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Country [1]
306238
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Malaysia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306071
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Medical Research & Ethics Committee (MREC), Ministry of Health Malaysia
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Ethics committee address [1]
306071
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NMRR & MREC Clinic, Institute of Health Management,
Jalan Rumah Sakit, Bangsar,
59000 Kuala Lumpur, Malaysia
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Ethics committee country [1]
306071
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Malaysia
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Date submitted for ethics approval [1]
306071
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13/04/2018
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Approval date [1]
306071
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21/08/2018
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Ethics approval number [1]
306071
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KKM/NIHSEC/ P18-1307 (13)
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Summary
Brief summary
The general objective of the present study is to evaluate the impact of pharmacist intervention in DMTAC services of the public hospital in Kedah state of Malaysia on clinical outcomes (in the form of HbA1c) of diabetes mellitus,
Null Hypothesis:
H0: DMTAC services in public hospitals of Malaysia do not have any significant effect on the clinical outcomes on diabetic patients.
Alternative Hypothesis:
H1: DMTAC services in public hospitals of Malaysia have a significant effect on the clinical outcomes on diabetic patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Muhammad Zahid Iqbal
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Address
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Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
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Country
102598
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Malaysia
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Phone
102598
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+60169729584
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Fax
102598
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Email
102598
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[email protected]
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Contact person for public queries
Name
102599
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Dr Muhammad Zahid Iqbal
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Address
102599
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Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
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Country
102599
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Malaysia
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Phone
102599
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+60169729584
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Fax
102599
0
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Email
102599
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[email protected]
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Contact person for scientific queries
Name
102600
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Dr Muhammad Zahid Iqbal
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Address
102600
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Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University,08100, Bedong, Kedah Darul Aman, Malaysia
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Country
102600
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Malaysia
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Phone
102600
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+60169729584
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Fax
102600
0
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Email
102600
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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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
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Available to whom?
only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor, etc.
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Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal, for IPD meta-analyses, etc
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How or where can data be obtained?
access subject to approvals by Principal Investigator (Email:
[email protected]
), etc.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
12219
Informed consent form
379885-(Uploaded-23-06-2021-15-50-16)-Study-related document.pdf
12220
Ethical approval
379885-(Uploaded-23-06-2021-15-51-34)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF