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Trial registered on ANZCTR


Registration number
ACTRN12622000996763
Ethics application status
Approved
Date submitted
10/05/2022
Date registered
15/07/2022
Date last updated
23/04/2024
Date data sharing statement initially provided
15/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacist-led Intervention for Disease and Risk Management in Patients with Ischemic Heart Disease
Scientific title
Pharmacist-led Intervention for Disease and Risk Management in Patients with Ischemic Heart Disease
Secondary ID [1] 307090 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Heart Disease 326250 0
Condition category
Condition code
Cardiovascular 323554 323554 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Step 1:
First of all, the study population (Ischemic Heart Disease Patients) will be selected from the selective cardiovascular settings and the attendance of each patient will be marked at the time of visit.
Step 2:
The Principle Investigator (Clinical Pharmacist) will check the patients profile and overview the patient disease and medicine history.
Step 3:
One-on-one face-to-face interventional counseling sessions e.g. cognitive behavioral therapy, open discussion of 30 minutes will be conducted on the ischemic patients about the disease and risk management, correct use of medicine and lifestyle modification (diet and exercise) fortnightly for 6 months. Risk factors for ischemic heart disease, medication routines, and current lifestyle practices will also be discussed with the patients fortnightly.
Both types of intervention (Digital Intervention and educational intervention) will be provided during interventional counseling sessions by the Clinical Pharmacist to ischemic patients at the start of the study and be advised to complete these at their own pace.
Digital Intervention:
The components of digital intervention include digital pictures, and short videos (3-15 minutes) to manage the disease. Online links of pictures and videos (Source: google and google scholar) will be shared weekly on their personal devices. Participants will be instructed to watch a short video outlining strategies that can be used to manage their risk factors and ischemic heart disease progression. The adherence to intervention and patient’s response will be monitored after 6 months of study via a study-specific questionnaire about whether they watched the video and what they learned from the videos.
Educational intervention:
The online available written material providing advice to modify lifestyle risk factors to manage disease progression will be used for educational intervention. It is expected that participants will spend a minimum of half an hour and a maximum of an hour reading through the content.
Step 4:
The participant’s response will be monitored via a study-specific questionnaire after 6 months of interventional session.
Intervention code [1] 323545 0
Prevention
Intervention code [2] 323544 0
Lifestyle
Intervention code [3] 323546 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331514 0
To assess the role of Clinical Pharmacist for primary and secondary prevention of disease with a study-specific questionnaire
Timepoint [1] 331514 0
6 months post-intervention commencement
Primary outcome [2] 331513 0
Quality of life of ischemic patients will be assessed by study-specific questionnaire
Timepoint [2] 331513 0
6 months post-intervention commenecent
Primary outcome [3] 331515 0
Prevalence of risk factors assessed using a study-specific questionnaire.
Timepoint [3] 331515 0
6 months post-intervention commencement
Secondary outcome [1] 411417 0
Participant response about disease and risk management will be assessed via study specific questionnaire
Timepoint [1] 411417 0
6 months post-intervention commencement
Secondary outcome [2] 411416 0
Health Economic benefits such as quality-adjusted life-years (QALYs) will be assessed by calculating patient out-of-pocket costs and study-specific questionnaire
Timepoint [2] 411416 0
6 months post-intervention commencement

Eligibility
Key inclusion criteria
Patients with confirmed ischemic heart diseases (e.g Myocardial infarction, angina, history of atherosclerosis) who are admitted to and taking follow-up treatment in the Punjab Institute of Cardiology (PIC) hospital will be recruited for the study. Patients with a previous history of coronary heart disease will also be included. Informed consent will be taken from the patients before conducting the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiovascular patients other than ischemic heart diseases will be excluded from the study. Patients who have a shorter stay in the hospital, do not have to ability to self-care, cognitively impaired patients, allergic or contraindicated to cardiovascular medicines, have communicable diseases, and could not complete the study due to hepatic or renal insufficiencies and refused to include in the study would be excluded from the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS version 23 will be used to analyze the data. Means and standard deviation will be used to present the continuous data and categorical data will be presented in the form of numbers and percentages. The impact of clinical pharmacist intervention will be determined through regression modeling. 95% confidence interval (CI) will be used to estimate the data. Pearson Chi-square test will be used to compare the results before and after the intervention study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2022
Date of last participant enrolment
Anticipated
Actual
10/05/2022
Date of last data collection
Anticipated
31/12/2022
Actual
31/12/2022
Sample size
Target
300
Accrual to date
Final
330
Recruitment outside Australia
Country [1] 24758 0
Pakistan
State/province [1] 24758 0
Punjab

Funding & Sponsors
Funding source category [1] 311398 0
Government body
Name [1] 311398 0
Higher Education Commission, Pakistan
Country [1] 311398 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Amjad Khan
Address
Department of Pharmacy, Quaid-i-Azam University Islamabad, Postcode : 45320
Country
Pakistan
Secondary sponsor category [1] 312951 0
University
Name [1] 312951 0
Quaid-i-Azam University Islamabad
Address [1] 312951 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, Postcode: 45320
Country [1] 312951 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310880 0
Ethical review committee Punjab Institute of Cardiology Lahore
Ethics committee address [1] 310880 0
Ethics committee country [1] 310880 0
Pakistan
Date submitted for ethics approval [1] 310880 0
01/06/2021
Approval date [1] 310880 0
20/12/2021
Ethics approval number [1] 310880 0

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

Contacts
Principal investigator
Name 119206 0
Dr Umm-e-Kalsoom
Address 119206 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, Capital Territory 15320
Country 119206 0
Pakistan
Phone 119206 0
+923007202068
Fax 119206 0
Email 119206 0
ukalsoom@bs.qau.edu.pk
Contact person for public queries
Name 119207 0
Amjad Khan
Address 119207 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, Capital Territory 15320
Country 119207 0
Pakistan
Phone 119207 0
+925190644128
Fax 119207 0
Email 119207 0
ukalsoom@bs.qau.edu.pk
Contact person for scientific queries
Name 119208 0
Umm-e-Kalsoom
Address 119208 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, Capital Territory 15320
Country 119208 0
Pakistan
Phone 119208 0
+923007202068
Fax 119208 0
Email 119208 0
ukalsoom@bs.qau.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication and will be available for 5 years
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose i.e for further study
How or where can data be obtained?
Data will be shared by Principal Investigator; Dr. Umm-e-Kalsoom (ukalsooml@bs.qau.edu.pk) and primary sponser; Dr. Amjad Khan (amjadkhan@qau.edu.pk)


What supporting documents are/will be available?

No Supporting Document Provided


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.