Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000234718
Ethics application status
Approved
Date submitted
17/08/2021
Date registered
9/02/2022
Date last updated
2/03/2023
Date data sharing statement initially provided
9/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancement of pharmacist role for the management of Chronic Obstructive Pulmonary Disease (COPD) in Pakistan
Scientific title
Management of COPD and other Comorbidities in COPD Patients by Dispensing Pharmaceutical Care following the Global Initiative for Chronic Obstructive Lung disease-guidelines (GOLD guidelines 2020) : A Prospective Clinical Trial.
Secondary ID [1] 306312 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 323264 0
Condition category
Condition code
Respiratory 320833 320833 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study has two arms
Arm 1: There will be only educational intervention provided to this group (COPD patients) by the principle investigator ( Counselling about the disease, correct use of medication and life style modification ( Diet and Exercise). This study group will receive the onging medication prescribed by the physician.
Arm 2 : There will be a pharmacological intervention will be provided according to the GOLD guidelines as following
step 1: The patients will be diagnosed following the standard procedure mentioned in GOLD guidelines.
Step 2: Then pharmacological treatment will be given according to the GOLD guidelines
Step 3: Educational intervention ( 30 minute face-to-face patient counselling) will be provided also as mentioned in Arm 1
Study Activities:
1: At the time of patient enrollment interventions will be provided to both groups
2: After every 2 months patients will be called for checking adherence to the interventions by interviewing the patients and by checking patient prescriptions and medications used by patients
3: The patients will be enrolled at Out patient department of ' Holy Family Hospital Rawalpindi, Pakistan' and interventions will be provided by the principle investigator
4 : The interventions will be provided only once
5: Response will be gathered after 6 months by checking disease state, patient quality of life and No. of acute exacerbation during this period of study
Intervention code [1] 321454 0
Treatment: Drugs
Intervention code [2] 322169 0
Treatment: Other
Comparator / control treatment
control group: The patients diagnosed with COPD will follow the ongoing treatment which is not following the GOLD guidelines with no educational intervention.
Control group
Active

Outcomes
Primary outcome [1] 328630 0
Quality of life assessed using the St. George's Respiratory Questionnaire
Timepoint [1] 328630 0
After 24 weeks/ 6 months of commencement of intervention the outcomes will be assessed
Primary outcome [2] 328631 0

No. of acute exacerbation will be assessed in intervention groups by using
a) Spirometry to check disease progression
b) No, of emergency hospital visits will be counted from patients medical record (prescriptions, lab reports etc),
c) Quality of life will be measured by the St George's Respiratory Questionnaire
Timepoint [2] 328631 0
24 weeks/ 6 months after interventions
Primary outcome [3] 328632 0
Disease progression will be assessed by spirometery ; Forced expiratory volume (FEV1) for 1 sec will be measure before and after intervention to study the impact of interventions
Timepoint [3] 328632 0
After 24 weeks/ 6 months of intervention disease progression will be assessed
Secondary outcome [1] 399759 0
Mortality rate of intervention group will be compared
Timepoint [1] 399759 0
After 1 year of interventions

Eligibility
Key inclusion criteria
Patients only attend the outpatient COPD wards, confirmed diagnosis of COPD by the hospital consultant for at least 1 year with a forced expiratory volume in 1 s (FEV1) of 30–80% of the predicted normal value, patients that hospital consultant agree that the patient is suitable for entering the trial will be included in this study.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they will have moderate to severe learning difficulties, mobility problems, confusion, disorientation or terminal illness, congestive heart failure or if they are attending a pulmonary rehabilitation programs consulting a pulmonary nurse or clinical pharmacist in the last 6 month will be excluded.

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)
Nil
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis Data collected at baseline and at the 6 month assessments will be coded and entered into SPSS software version 22 for statistical analysis (data screening, descriptive statistics and univariate analysis). Data will be examined using Chi-squared analysis for categorical variables. Regarding continuous variables, the Mann–Whitney U-test will be performed for the non-normally distributed variables and the independent t test was performed for normally distributed variables. A P value of 0.05 was considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
1/05/2023
Actual
Date of last data collection
Anticipated
1/11/2023
Actual
Sample size
Target
120
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 24044 0
Pakistan
State/province [1] 24044 0
Punjab

Funding & Sponsors
Funding source category [1] 309453 0
Government body
Name [1] 309453 0
Higher Education Commision Pakistan
Country [1] 309453 0
Pakistan
Primary sponsor type
Individual
Name
Amjad Khan
Address
Quaid-i-Azam University Islamabad, 45320, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 310422 0
None
Name [1] 310422 0
Address [1] 310422 0
Country [1] 310422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309246 0
Rawalpindi medical university Ethical Review Boards
Ethics committee address [1] 309246 0
Ethics committee country [1] 309246 0
Pakistan
Date submitted for ethics approval [1] 309246 0
13/01/2021
Approval date [1] 309246 0
23/04/2021
Ethics approval number [1] 309246 0
63/IREF/RMU/2021

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

Contacts
Principal investigator
Name 113478 0
Miss Hafsa Kanwal
Address 113478 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, 45320, Pakistan.
Country 113478 0
Pakistan
Phone 113478 0
+92 3446429220
Fax 113478 0
Email 113478 0
[email protected]
Contact person for public queries
Name 113479 0
Amjad Khan
Address 113479 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, 45320, Pakistan.
Country 113479 0
Pakistan
Phone 113479 0
+925190644128
Fax 113479 0
+925190644128
Email 113479 0
[email protected]
Contact person for scientific queries
Name 113480 0
Hafsa Kanwal
Address 113480 0
Department of Pharmacy, Quaid-i-Azam University Islamabad, 45320, Pakistan.
Country 113480 0
Pakistan
Phone 113480 0
+92 3446429220
Fax 113480 0
Email 113480 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?
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 Hafsa Kanwal and primary sponser Amjad Khan
[email protected], [email protected]


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.