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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Asthma

Condition category

Condition code

Respiratory

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]

Behaviour

Intervention code [2]

Lifestyle

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]

Asthma Control

Timepoint [1]

Baseline (pre-intervention data) and after 3 (primary timepoint) and 6 months after intervention.

Secondary outcome [1]

Patient's knowledge about asthma self-management

Timepoint [1]

Baseline and 3 and 6 months after pharmacist intervention

Secondary outcome [2]

Patient's medication adherence

Timepoint [2]

Baseline and 3 and 6 months after pharmacist intervention.

Secondary outcome [3]

Patient's correct use of inhaler

Timepoint [3]

Baseline and 3 and 6 months after pharmacist intervention.

Secondary outcome [4]

Patient's health related quality of life

Timepoint [4]

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?

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]

Pakistan

State/province [1]

Balochistan

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of Balochistan

Address

Country

Pakistan

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

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]

Department of Pharmacy Practice, University of Balochistan 87300, Saryab road, Quetta, Balochistan.

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

16/09/2024

Approval date [1]

24/03/2025

Ethics approval number [1]

nil

Summary

Brief summary

This study aims to assess the impact of pharmacist-led interventions on asthma management, medication adherence, and health-related quality of life (HRQoL). A randomized controlled trial will be conducted at a Fatima Jinnah chest hospital in Quetta with 150 asthmatic patients divided equally into control and intervention groups. The intervention group will receive personalized education and support from pharmacists, while the control group will receive standard care. Outcome measures will be assessed at baseline, month 3, and month 6 using validated tools, and analyzed using SPSS. Positive results could support a greater role for pharmacists in managing chronic diseases in Pakistan

Trial website

nil

Trial related presentations / publications

Public notes

nil

Contacts

Principal investigator

Name

Ms Hira Waheed

Address

Department of Pharmacy, University of Balochistan, Saryab road, Quetta Balochistan

Country

Pakistan

Phone

+923342165993

Fax

[email protected]

Contact person for public queries

Name

Hira Waheed

Address

Department of Pharmacy, University of Balochistan, Saryab road, Quetta, Balochistan

Country

Pakistan

Phone

+923342165993

Fax

[email protected]

Contact person for scientific queries

Name

Hira Waheed

Address

Department of pharmacy, University of Balochistan, Saryab road, Quetta, Balochistan

Country

Pakistan

Phone

+923342165993

Fax

[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?

Type	Citation	Link	Email	Other Details	Attachment
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.

Trial Review

Documents added manually

Documents added automatically