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Trial registered on ANZCTR


Registration number
ACTRN12622000658718
Ethics application status
Approved
Date submitted
22/02/2022
Date registered
4/05/2022
Date last updated
4/05/2022
Date data sharing statement initially provided
4/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacoeconomic evaluation of Pharmacist led diabetes education intervention in Type 2 diabetes patients Randomized Clinical Trial.
Scientific title
Cost of Illness, Health-Related Quality of Life and Cost-Effectiveness analysis of Pharmacist led lifestyle intervention among Type 2 Diabetes population in Pakistan.
Secondary ID [1] 306509 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Type 2 325378 0
Condition category
Condition code
Metabolic and Endocrine 322761 322761 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with Diabetes Mellitus Type 2 condition will be recruited. Two groups will be created one arm consists of the patient undergoing intervention for Pharmacist led diabetes education assessment and 1-year follow-up plan will be devised for the interventional arm. The interventional Diabetes Educator Pharmacist will compute the baseline parameters and document all relevant baseline details pertaining to cost, e.g Direct and Indirect cost. However, all patients will be followed up on the 3-month interval with a set appointment with Health Care Practionaire (HCP). On every visit there will be 30 minutes session to be performed with the participant and all parameters will be recorded again.
The mode of intervention will be the face-to-face interview and individualized care and education sessions will be performed.

The International Diabetes Federation (IDF)-defined protocol and Pakistan Population specified Baqi Institute of Diabetes and Endocrinology (BIDE) designed module and literature will be used. Diabetes education protocol will be briefed to patients upon inclusion into the study only those patients will be included who agreed to adhere and have no issue in time to time follow-up discussion.

Every 3 months following protocols for the intervention group will be used. The patient will be given an appointment for Physician Checkup and the Patient will then be referred to the Pharmacist for Diabetes Education and evaluation. In every visit following parameters will be covered.
1) Pre-consultation assessment for adherence. (5 Minutes)
2) Medication consultation: It will include any particular change recommended by the physician and modification in the dosing of the current medication. The modification in the medication regimen will be done based on the blood Glucose monitoring Log kept by the participants (10 Minutes)
3) Post-consultation interventional education session. (15 Minutes)


The diabetes education plan will contain the following aspects.
1- Diet and Exercise Counselling and targets.
2- Education on Hyperglycemia and Hypoglycemia.
3- Foot Care education.
4-Regular Blood Glucose Monitoring.

Validated Questionnaires will be used in every session to evaluate the patient's adherence to the previous education session.
The 14-item Michigan Diabetes Knowledge Test will be used to evaluate adherence.
Intervention code [1] 322934 0
Lifestyle
Intervention code [2] 322935 0
Behaviour
Comparator / control treatment
The Control group will consist of the patients who will not receive pharmacist-led diabetes education intervention. The control group will receive regular medication management as per standard protocols they will not be given interventional management of diabetes education.
The same protocol will be followed however the patient in the control group will be required to visit every 6 months for an evaluation of their medication regimen and consultation regarding any complications developed.

The control group patient will be following protocol.
1) Pre-Consultation assessment.
2) Medication Consultation.

If a patient at any stage changed their mind to have set protocolled diabetes education that patient will be excluded from the study.
Control group
Active

Outcomes
Primary outcome [1] 330558 0
Change in the overall out-of-pocket cost incurred by the patient evaluated from patient past medical history.
Timepoint [1] 330558 0
baseline, 26 weeks post-commencement of intervention and 52 weeks post-commencement of intervention,
Primary outcome [2] 330814 0
Serum HbA1c
Timepoint [2] 330814 0
baseline, 26 weeks post-commencement of intervention and 52 weeks post-commencement of intervention,
Secondary outcome [1] 406671 0
Quality of life assessed with WHOQOL
Timepoint [1] 406671 0
baseline, 26 weeks post-commencement of intervention and 52 weeks post-commencement of intervention,
Secondary outcome [2] 407688 0
Quality-Adjusted Life Years will be assessed using the patient's past medical record and adjusted quality of life.
Timepoint [2] 407688 0
baseline and 52 weeks post-commencement of intervention,
Secondary outcome [3] 408434 0
Change in Diabetes Knowledge using a validated 14-item Michigan Diabetes Knowledge Test questionnaire.
Timepoint [3] 408434 0
Baseline, 26 weeks post-commencement of intervention, 52 weeks post-commencement of intervention
Secondary outcome [4] 408435 0
Change in Body Mass Index (BMI) for BMI assessment will be done using height measured with a stadiometer and weight measured with digital scales',
Timepoint [4] 408435 0
Baseline and 52 weeks post-commencement of intervention,

Eligibility
Key inclusion criteria
Individuals aging 20 years and above, with a confirmed diagnosis of T2DM and ability to read and write Urdu (the official language of Pakistan) were incorporated in the study.
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, patients with type I diabetes mellitus, having severe diabetic complications, psychiatric disorder and immigrants from other countries

Study design
Purpose of the study
Educational / counselling / training
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)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
326
Accrual to date
Final
Recruitment outside Australia
Country [1] 24599 0
Pakistan
State/province [1] 24599 0
Punjab

Funding & Sponsors
Funding source category [1] 310852 0
Self funded/Unfunded
Name [1] 310852 0
Muhammad Daoud Butt
Country [1] 310852 0
Malaysia
Primary sponsor type
Individual
Name
Muhammad Daoud Butt
Address
J04 Room 101C School of Pharmaceutical Sciences Universiti Sains Malaysia, 11800 Gelugor, Penang, Malaysia
Country
Pakistan
Secondary sponsor category [1] 312109 0
Hospital
Name [1] 312109 0
Umar Diabetes Foundation
Address [1] 312109 0
Umar Diabetes Foundation Malak shafait plaza, Mauza Mahal kot, Hathial, Main Murree Rd, Bhara Kahu, Islamabad, Islamabad Capital Territory 44000
Country [1] 312109 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310417 0
Ethical Committee of Department of Pharmacy Practice
Ethics committee address [1] 310417 0
Ethics committee country [1] 310417 0
Pakistan
Date submitted for ethics approval [1] 310417 0
03/01/2022
Approval date [1] 310417 0
18/01/2022
Ethics approval number [1] 310417 0
ACAD/EXT/01/2022

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

Contacts
Principal investigator
Name 117590 0
Mr Muhammad Daoud Butt
Address 117590 0
J04 Room 101C
School of Pharmaceutical Sciences
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Gelugor, Penang, Malaysia
Country 117590 0
Malaysia
Phone 117590 0
+6046533888
Fax 117590 0
Email 117590 0
daoudbutt@student.usm.my
Contact person for public queries
Name 117591 0
Siew Chin ONG
Address 117591 0
Senior Lecturer
J04 Room 101C
School of Pharmaceutical Sciences
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Gelugor, Penang, Malaysia
Country 117591 0
Malaysia
Phone 117591 0
+60124770883
Fax 117591 0
Email 117591 0
siewchinong@usm.my
Contact person for scientific queries
Name 117592 0
Muhammad Fawad Rasool
Address 117592 0
Associate Professor & Chairman, Department of Pharmacy Practice, Faculty of Pharmacy, Bahauddin Zakariya University Multan, Punjab 60000 Pakistan
Country 117592 0
Pakistan
Phone 117592 0
+92619210129
Fax 117592 0
Email 117592 0
fawadrasool@bzu.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No such data will be share of the participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15188Study protocol  daoudbutt@student.usm.my 383633-(Uploaded-22-02-2022-22-47-16)-Study-related document.docx
15189Ethical approval  daoudbutt@student.usm.my 383633-(Uploaded-22-02-2022-22-47-52)-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.