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Trial registered on ANZCTR


Registration number
ACTRN12619001618145
Ethics application status
Approved
Date submitted
28/07/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and Implementation of Pharmacist-based Diabetic Intervention Model in type-2 diabetes patients in Pakistan: A randomized controlled trial
Scientific title
Development and Implementation of Pharmacist-based Diabetic Intervention Model for patients with type-2 diabetes in Pakistan and impact on Glycated Hemoglobin: A randomized controlled trial
Secondary ID [1] 298733 0
None
Universal Trial Number (UTN)
U1111-1236-9790
Trial acronym
PDIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 313662 0
Condition category
Condition code
Metabolic and Endocrine 312077 312077 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Around 110 patients will be taken. They will be block randomized into control and intervention group
Pharmacist-based Diabetic Intervention Model (PDIM) includes "Diabetes Educational Module (booklet in both english and local language urdu)", "Medication Adherence improvement strategies" and "tele-pharmacy services" that will be delivered by a Pharmacist, 4 times in a month, at community pharmacy setup.
"Diabetes Educational Module" consists of a booklet that shall be provided to the patient for disease knowledge improvement. This booklet is specifically designed.
Medication improvement adherence strategies shall involve a well designed way of counselling patients, providing drug information by tele-pharmacy services. Subject health, adherence and other self care practice that patient is adopting can be assessed by telephone services for the purpose of follow-up.
Intervention code [1] 314998 0
Treatment: Other
Intervention code [2] 314999 0
Behaviour
Comparator / control treatment
Subjects shall be allocated to control and intervention by block randomization method.
Control group shall receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 320711 0
HbA1C
by Serum assay
Timepoint [1] 320711 0
180 days
Primary outcome [2] 320712 0
Medication adherence by Morisky Medication Adherence Scale (MMAS)
Timepoint [2] 320712 0
180 days
Primary outcome [3] 320713 0
Health Related Quality of Life
by Euro Qol EQ-5D-5L
Timepoint [3] 320713 0
180 days
Secondary outcome [1] 372589 0
Blood pressure
by using automated machine
Timepoint [1] 372589 0
180 days
Secondary outcome [2] 372590 0
Lipid Profile (Triglycerides, cholesterol, HDL, LDL)
by serum assay
Timepoint [2] 372590 0
180 days
Secondary outcome [3] 372591 0
Body Fats
by using Fat analyzer machine
Timepoint [3] 372591 0
180 days
Secondary outcome [4] 375060 0
BMI
by using fat analyzer machine (Omron Fat analyzer Model: BF508)
A stadiometer will used to assess height in centimeters.
Timepoint [4] 375060 0
180 days

Eligibility
Key inclusion criteria
Type-2 diabetes mellitus
Minimum age
30 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Juvenile Type Diabetes
Type-1 diabetes
Dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized Block randomization method in which age, gender, QoL, Adherence score and diabetes facts score will be the co-variates.
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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21686 0
Pakistan
State/province [1] 21686 0
Punjab

Funding & Sponsors
Funding source category [1] 303287 0
Government body
Name [1] 303287 0
Higher Education Commission
Address [1] 303287 0
H-9/4 H 9/4 H-9, Street 3, Islamabad, Islamabad Capital Territory
Country [1] 303287 0
Pakistan
Primary sponsor type
Individual
Name
Tauqeer Hussain
Address
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country
Pakistan
Secondary sponsor category [1] 303306 0
Individual
Name [1] 303306 0
Malik Hassan Mehmood
Address [1] 303306 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country [1] 303306 0
Pakistan
Other collaborator category [1] 280853 0
Individual
Name [1] 280853 0
Mustafa Ijaz
Address [1] 280853 0
Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country [1] 280853 0
Pakistan
Other collaborator category [2] 280854 0
Individual
Name [2] 280854 0
Zulqarnain Haider
Address [2] 280854 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country [2] 280854 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303823 0
Institutional Ethical Committee of Government College University Faisalabad
Ethics committee address [1] 303823 0
Government College University,
Allama Iqbal Road.
Faisalabad Pakistan
Ethics committee country [1] 303823 0
Pakistan
Date submitted for ethics approval [1] 303823 0
31/07/2019
Approval date [1] 303823 0
01/08/2019
Ethics approval number [1] 303823 0
GCUF/ERC/2065

Summary
Brief summary
The study is designed as prospective, randomized controlled trial. In this study, around 110 patients shall be screened and allocated into groups based upon block randomization method.
Pre- and Post-Intervention data from subjects shall be recorded on prestructured data collection form and the time between these two points shall be of 6 months.
Intervention includes education about disease and treatment. The impact of this intervention on HbA1C and the secondary outcomes like BMI, visceral fats and body fats shall be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94934 0
Dr Tauqeer Hussain Mallhi
Address 94934 0
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country 94934 0
Pakistan
Phone 94934 0
+923007600072
Fax 94934 0
Email 94934 0
tauqeer.hussain.mallhi@gmail.com
Contact person for public queries
Name 94935 0
Mr Mustafa Ijaz
Address 94935 0
Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country 94935 0
Pakistan
Phone 94935 0
+923357393376
Fax 94935 0
Email 94935 0
mustafaijaz78@gmail.com
Contact person for scientific queries
Name 94936 0
Dr Tauqeer Hussain Mallhi
Address 94936 0
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Government College University, Kotwali Road, Gurunanakpura, Faisalabad-38000, Punjab
Country 94936 0
Pakistan
Phone 94936 0
+923007600072
Fax 94936 0
Email 94936 0
tauqeer.hussain.mallhi@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the data
When will data be available (start and end dates)?
9/23/2019-9/23/2021
Available to whom?
Researchers only
Available for what types of analyses?
any purpose
How or where can data be obtained?
by email application to principal investigator or primary sponsor
tauqeer.hussain.mallhi@hotmail.com
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary