Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000661471
Ethics application status
Approved
Date submitted
21/05/2025
Date registered
23/06/2025
Date last updated
23/06/2025
Date data sharing statement initially provided
23/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Pharmacist intervention on asthma management
Scientific title
Impact of Pharmacist intervention in Asthma control: A Parallel Group Randomized Controlled Trial in Outpatients
Secondary ID [1] 314600 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 337580 0
Condition category
Condition code
Respiratory 333925 333925 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All eligible clinically diagnosed asthma outpatients receiving regular treatment at Fatima Jinnah Institute of Chest Diseases, Quetta, Balochistan will be included in the study. A pharmacist trained in the pathophysiology, management of asthma, and use of the current study protocol will administer the intervention. The intervention will include one-on-one sessions. There will be 2 sessions of one hour per week and sessions will continue for 6 weeks (with proper marked attendance of patients for each session) during which pharmacist will educate the patient on basic facts about asthma, understanding difference between the controller and reliever medications, taking medications correctly, correct use of inhaler, spacer, nebulizer etc., identifying and avoiding environmental exposure that exacerbate asthma, self-monitoring to assess the level of asthma control, monitor and recognize early signs and symptoms of worsening asthma, and provide written action plans to know when and how to take daily actions to control asthma, adjust medications in response to signs of worsening asthma, and when to seek medical care. Written Action Plan, developed by the National Institutes of Health (NIH), will be provided to each patient. This action plan will include detailed instructions on daily actions to control asthma, how to adjust medications in response to changing symptoms, and when to seek medical care. Patients will be taught how to write and personalize their own action plan, ensuring they can monitor their asthma and adjust treatments effectively. Patient outcomes, including inhaler technique, asthma control, quality of life, and medication adherence, will be measured using the 11 items checkpoint of inhaler technique (WHO), Asthma Control Questionnaire (ACQ), the Asthma Quality of Life Questionnaire (AQLQ), and the General Medication Adherence Scale (GMAS), respectively. These tools are available in Urdu, and permission has been granted to use them in their authorized version and self designed data collection form will be used. This comprehensive program will empower patients to manage their asthma effectively and make informed decisions about their health.
Intervention code [1] 331222 0
Lifestyle
Intervention code [2] 331134 0
Behaviour
Comparator / control treatment
All eligible clinically diagnosed asthma outpatients matched on the basis of age, asthma severity, comorbidity, smoking and medication adherence status, receiving regular treatment without pharmacist intervention at Fatima Jinnah Institute of Chest Diseases, Quetta, Balochistan will be included in the study as a control group.
Control group
Active

Outcomes
Primary outcome [1] 341574 0
Asthma Control
Timepoint [1] 341574 0
Baseline (pre-intervention data) and after 3 (primary timepoint) and 6 months after intervention.
Secondary outcome [1] 447975 0
Patient's knowledge about asthma self-management
Timepoint [1] 447975 0
Baseline and 3 and 6 months after pharmacist intervention
Secondary outcome [2] 447977 0
Patient's correct use of inhaler
Timepoint [2] 447977 0
Baseline and 3 and 6 months after pharmacist intervention.
Secondary outcome [3] 447976 0
Patient's medication adherence
Timepoint [3] 447976 0
Baseline and 3 and 6 months after pharmacist intervention.
Secondary outcome [4] 447978 0
Patient's health related quality of life
Timepoint [4] 447978 0
Baseline and 3 and 6 months after pharmacist intervention

Eligibility
Key inclusion criteria
Outpatients diagnosed with asthma aged 18 years and above
Receiving asthma medication for the past 6 months at least
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who cannot understand and read Urdu.
Pregnant patients.
Patients unable to communicate.
Patients with comorbidities affecting asthma management e.g. patients with chronic obstructive pulmonary disease (COPD).
Patient with a documented chest infection in the last four weeks

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)
Not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Adaptive co-variate randomization (ACR) technique will be adopted.
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
Sample size for this study was calculated by using the following Two-Sample t-Test formula for comparing means.
n= 2 (Za/2+ Zß)2 x SD2
(µ1-µ2)2

Statistical Package for the Social Sciences (SPSS version 26) will be used for data analysis. One-way repeated measures ANOVA will be was used to observe change in ASMQ, Inhaler technique, GMAS, AQLQ and ACQ scores over the time. GLM repeated measures ANOVA will be used to observe that whether there is an interaction effect and patients have a different form of change over time and which are the predictor of predictive of change in patients’ outcome scores. A p-value <0.05 will reflect statistically significant findings. Cohen’s proposed guidelines will be used for grading the effect size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 27078 0
Pakistan
State/province [1] 27078 0
Balochistan

Funding & Sponsors
Funding source category [1] 319025 0
Self funded/Unfunded
Name [1] 319025 0
Country [1] 319025 0
Primary sponsor type
University
Name
University of Balochistan
Address
Country
Pakistan
Secondary sponsor category [1] 321489 0
None
Name [1] 321489 0
Address [1] 321489 0
Country [1] 321489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317634 0
Research and ethics review committee of Department of Pharmacy Practice, Faculty of Biological, Pharmaceutical and Health sciences, University of Balochistan, Quetta
Ethics committee address [1] 317634 0
Ethics committee country [1] 317634 0
Pakistan
Date submitted for ethics approval [1] 317634 0
16/09/2024
Approval date [1] 317634 0
24/03/2025
Ethics approval number [1] 317634 0
nil

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

Contacts
Principal investigator
Name 141638 0
Ms Hira Waheed
Address 141638 0
Department of Pharmacy, University of Balochistan, Saryab road, Quetta Balochistan
Country 141638 0
Pakistan
Phone 141638 0
+923342165993
Fax 141638 0
Email 141638 0
[email protected]
Contact person for public queries
Name 141639 0
Hira Waheed
Address 141639 0
Department of Pharmacy, University of Balochistan, Saryab road, Quetta, Balochistan
Country 141639 0
Pakistan
Phone 141639 0
+923342165993
Fax 141639 0
Email 141639 0
[email protected]
Contact person for scientific queries
Name 141640 0
Hira Waheed
Address 141640 0
Department of pharmacy, University of Balochistan, Saryab road, Quetta, Balochistan
Country 141640 0
Pakistan
Phone 141640 0
+923342165993
Fax 141640 0
Email 141640 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Institutional policies



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Asthma study protocol.docx


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.