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Trial registered on ANZCTR


Registration number
ACTRN12623000370606
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
13/04/2023
Date last updated
26/05/2024
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of pharmacist led interventions for drug related problems among chronic kidney disease patients: A randomized control trial
Scientific title
Impact of pharmacist led interventions for drug related problems among chronic kidney disease patients: A randomized control trial
Secondary ID [1] 308958 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 328968 0
Other renal associated disorders 328969 0
Other cardiovascular diseases 328970 0
Diabetes 328971 0
renal and urogenital disorders 329467 0
Condition category
Condition code
Renal and Urogenital 326401 326401 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the randomized control trial, patients meeting the inclusion criteria will be randomly assigned to control group and intervention group after taking consent for participation in the study. Data collection form will be designed and developed in order to record patient demographics, medications history, prescribed drugs and laboratory parameters, stages of chronic kidney disease based on Cockgraft Gault Equation. Patient quality of life will be assessed by using a Functional Assessment of Non-Life Threatening Conditions [FANLTC] (Version 4) questionnaire at baseline and also at end of study (12 week).

The patients in control group will be having usual medication and usual care as per their routine without any involvement of pharmacist or counseling.

The patients in the intervention group will be given a counseling session by the pharmacist regarding disease knowledge, medication reconciliation, need of dose adjustment and drug-interactions in CKD patients, and its impact on disease progression and quality of life (QOL), where needed either during hospital stay or at the time of discharge, anticipated to take up to 15 to 20 minutes .
Drug related problems and levels of Pharmacy Intervention will be classified, based on the Pharmaceutical Care Network Europe [PCNE] Scale version 9.1, British National Formulary [BNF] will be used to identify drugs requiring special renal dose adjustments while drug interactions will be assessed by using Lexicomp Up to date Software.
At end point (12 weeks) the patient quality of life will be assessed by using Functional Assessment of Non-Life Threatening Condition [FANLTC] questionnaire.
Intervention code [1] 325406 0
Treatment: Other
Intervention code [2] 325407 0
Treatment: Drugs
Comparator / control treatment
The participants in control group will be having usual medications and care as per their routine without any involvement of pharmacist or pharmacist led interventions and counseling.
Control group
Active

Outcomes
Primary outcome [1] 333806 0
Impact of pharmacist led interventions for drug related problems (including dose related, drug interactions, side effect or if any) in chronic kidney disease patients will be classified based on the Pharmaceutical care network Europe association PCNE scale version 9.1
Timepoint [1] 333806 0
At baseline (0 week) and endpoint (12 week) post randomization
Secondary outcome [1] 420239 0
Assessment for Quality of Life of chronic kidney disease patients will be conducted using the Functional Assessment of Non-Life Threatening Conditions [FANLTC] (version 4) questionnaire to compare the impact of pharmacist counseling and adjustment of drug related problems.
Timepoint [1] 420239 0
At baseline (0 week) and end point (12 week) post randomization

Eligibility
Key inclusion criteria
Participants of this RCT must be adult patients of 18 years and above, both genders who currently had or previously diagnosed with all stages of renal disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not having renal disease,those who are pregnant and breastfeeding and not willing to participate.

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)
To ensure adequate concealment of allocation, the patients handpick a numbered envelope from the basket.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomized into two groups i.e. controlled and intervention group. Simple random technique will be used to form a list of random numbers of eligible patients which will be compiled by using the patients’ hospital identification numbers. After recruitment, the patients will be requested to handpick an envelope from the basket indicating allocation to either control or intervention group with 1:1 randomization.
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

All analysis will be performed using SPSS v-20 and a p-value of <0.05 will be set as significance level. Pharmaceutical care network Europe Association version 9.1 (PCNE) measuring tool will be used to find drug related problems. Data will be presented in frequencies and percentages for categorical, while in mean and standard deviation for continuous data. Further statistical test whichever is suitable will be performed depending on data collection.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2023
Actual
15/04/2023
Date of last participant enrolment
Anticipated
15/07/2023
Actual
31/10/2023
Date of last data collection
Anticipated
15/08/2023
Actual
31/10/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 25253 0
Pakistan
State/province [1] 25253 0
Khyber Pukhtoonkhwa

Funding & Sponsors
Funding source category [1] 313171 0
Self funded/Unfunded
Name [1] 313171 0
Roheena Zafar
Country [1] 313171 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Inayat Ur Rehman (PhD Clinical Pharmacy)
Address
Dr. Inayat Ur Rehman (PhD Clinical Pharmacy)
Good Clinical Practice Certified (NIDA Clinical Trials Network)
Department of pharmacy
Abdul Wali Khan University Mardan,
Khyber Pakhtoon khwa,
Pakistan

post code 25000
Country
Pakistan
Secondary sponsor category [1] 314878 0
None
Name [1] 314878 0
Address [1] 314878 0
Country [1] 314878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312412 0
Northwest General Hospital and Research Center, Peshawar, Pakistan
Ethics committee address [1] 312412 0
Northwest General Hospital and Research Center,
Sector A-3, Phase V, Hayatabad, Peshawar,
Khyber Pakhtoon Khwa,
Pakistan.
Ethics committee country [1] 312412 0
Pakistan
Date submitted for ethics approval [1] 312412 0
21/10/2021
Approval date [1] 312412 0
29/11/2021
Ethics approval number [1] 312412 0
NwGH/DMENEC I I 7 26

Summary
Brief summary
Chronic kidney disease (CKD) is considered as a major public health concern affecting 10-15% of the world population. Worldwide, hypertension and diabetes are considered the main causes of CKD and these patients need to be prescribed multiple drugs. Hence; increasing the risk of drug related problems. In Pakistan, the healthcare system is already overburdened, Clinical Pharmacist being a member of the healthcare team, is at a better position if involved in monitoring of drug therapies. The main goal of managing CKD is to improve patients’ quality of life (QoL) by delaying progression of CKD related complications, increase patient survival rate and reduce the healthcare cost. The aim of this study is to determine the impact of pharmacist led interventions for avoiding drug related problems and to understand the comparison of renal dose adjustment, drug interactions and pharmacist knowledge in health care setting among CKD patients in Pakistan. The present study is designed as a randomized control trial. In randomized control trial, for intervention group, a proper pharmacist led interventions will be designed and developed to address the drug related problems including drug interactions in order to improve therapeutic outcomes. Drug related problems and Levels of Pharmacy Intervention will be classified, based on the Pharmaceutical Care Network Europe [PCNE] Scale version 9.1. Patient quality of life (QoL) will be assessed by using a Functional Assessment of Non-Life Threatening Conditions [FANLTC] (Version 4) questionnaire. British National Formulary, Drug Facts and Comparison will be used to identify drugs requiring special renal dose adjustments while drug interactions will be assessed by using Lexicomp Up to date Software.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124566 0
Dr Inayat Ur Rehman
Address 124566 0
Dr. Inayat Ur Rehman (PhD Clinical Pharmacy)
Good Clinical Practice Certified (NIDA Clinical Trials Network)
Department of pharmacy
Abdul Wali Khan University Mardan,
Khyber Pukhtoon Khwa, Pakistan
post code 25000
Country 124566 0
Pakistan
Phone 124566 0
+923348338380
Fax 124566 0
Email 124566 0
[email protected]
Contact person for public queries
Name 124567 0
Roheena Zafar
Address 124567 0
Ph.D scholar, Director Pharmacy, Northwest General hospital and research center,
sector A-3, Phase V, hayatabad, Peshawar, Khyber Pukhtoon Khwa, Pakistan
Postal code 25000
Country 124567 0
Pakistan
Phone 124567 0
+923349100509
Fax 124567 0
Email 124567 0
[email protected]
Contact person for scientific queries
Name 124568 0
Dr. Inayat Ur Rehman
Address 124568 0
Dr. Inayat Ur Rehman ,
Certified (NIDA Clinical Trials Network) Department of pharmacy Abdul Wali Khan University Mardan, Khyber Pukhtoon Khwa, Pakistan post code 25000
Country 124568 0
Pakistan
Phone 124568 0
+923348338380
Fax 124568 0
Email 124568 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?
Underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Anyone who wishes to access it
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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