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Trial registered on ANZCTR


Registration number
ACTRN12624000433505
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of pharmacist’s intervention in medication therapy management (MTM) program for asthma on clinical and disease outcomes of asthma.
Scientific title
The impact of pharmacist’s intervention in medication therapy management (MTM) program for asthma on the Quality of life, Cost of treatment, Adherence with medications and clinical outcomes of asthma.
Secondary ID [1] 309578 0
SS522023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthmatic patients 329884 0
Condition category
Condition code
Respiratory 326788 326788 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Asthma patients recruited for the current trial belonging to the interventional group would undergo educational intervention. This educational intervention would be conducted at the patient counselling rooms in MTM clinics located within the premises of different hospitals.
The registered licensed pharmacist (who would also be principal investigator) would conduct educational intervention that include personalized interview/ counselling session with the patient. Incase if patient has any disability or cognitive problem, the caretaker of patient would be provided counselling.
The educational intervention would be individually given to patients and in person in medication therapy management clinics within district health quarters (DHQ) in Pakistan. This educational intervention will be divided in 3 sessions, with a total of 3 sessions of 30-40 minutes. The approximate time duration for each visit of patients was of 2-3 months, therefore, one module of intervention would be delivered to patient during each visit.
During counselling sessions, the patient would be guided in three modules containing information regarding their disease, treatment protocols and procedures. Moreover, occupational therapy as well as the lifestyle modifications would be guided to the patient. The detail of each module included in the educational intervention is discussed below:
The brief description of the educational intervention is as follows:
First Module of Educational Intervention (Visit-1)
The first module of educational intervention would provide following information to the patients:
Basic description of Asthma (sign, symptoms, indications).
Pharmacist will inquire about past medical, medication and family history for asthma, Pulmonary Function test (PFT) results,
adherence history and inhaler technique of patient.
Pharmacist will describe the therapeutic indications (Pulmonary Function test (PFT), Forced Expiratory Volume (FEV) etc) to patients,
Detailed guidance regarding the prescribed asthma medications (corticosteroids, bronchodilators),
the importance of adherence and compliance with the prescribed medication,
the signs and symptoms of acute asthma attacks and asthma exacerbations,
the importance of allergen testing,
the importance of smoking cessation,
occupational therapy for asthma and the necessary medications that should be available at home for acute asthma attacks.
Patients would be instructed on the proper use of Peak flow meter to monitor peak expiratory flow (PEF) and maintain record in patient logbook.
Afterwards, patients concerns and queries would be addressed.

Second Module of Educational Intervention (Visit-2)
The second module covers the following education for the patients:
Educating patients regarding the prescribed drug therapy,
possible trigger factors of asthma,
measures for avoiding trigger factors and the benefits of avoiding allergens for prevention of asthma exacerbations.
The precautions to be taken at home to avoid asthma exacerbations.
The importance of anti-histamine medications uses in asthma,
proper use of medications,
the importance of steroids especially inhaled corticosteroids in asthma management,
the proper usage technique of inhalers,
the importance of nebulizing frequently,
the proper usage technique of nebulizer that is being used by the patient.
The importance of medication adherence,
the adverse drug reactions (ADR) associated with the asthma medications would be described to patients (corticosteroids, beta agonists, Theophylline, Leukotriene, anti-histamines).
Afterwards, patients concerns and queries would be addressed.

Third Module of Educational Intervention (Visit-3)
The third module covers the following education for the patients:
Benefits of life style modifications,
mild exercise (10-15 minutes of walk),
improving diet intake especially including anti-inflammatory food items in diet,
control of stress & anxiety,
avoiding smoke,
avoidance of environmental allergens (dust, pollens),
the cons of having pets and birds at home,
the incidence of cold/flu and its management at home.
Furthermore, the detailed outline of asthma complications (Hypotension, Respiratory acidosis, Chronic airways inflammation, Sleep apnea, Pneumonia), their prevention, recognition and treatment would be guided to patients.
Afterwards, patients concerns and queries would be addressed.
Intervention code [1] 326006 0
Lifestyle
Intervention code [2] 328252 0
Behaviour
Comparator / control treatment
The principal investigator would not intervene in the clinical treatment of the group of patients belonging to the control group. Patients will continue to receive treatment from their assigned physicians/ pulmonologists according to the hospitals treatment protocols. Moreover, the principal investigator would not provide any sort of intervention to the patient lying in the control group.
Control group
Active

Outcomes
Primary outcome [1] 334640 0
The primary outcome of this study is to evaluate the asthma control of adult asthmatic patients with and without the involvement of pharmacists in hospital settings.
Specific Name: Asthma Control with ACQ scores>1
Objective Form: Improvement in asthma control.
Instruments used: Asthma Control would be assessed by following methods:
1. Pulmonary Function Tests (Spirometry)
2. Questionnaire- ACQ 7 Asthma Control Questionnaire.
ACQ-7 is the questionnaire that is available in English as well as Urdu (native language). The legal permission has been attained from the copyright holders by principal investigator for using it upon Pakistani population.
Timepoint [1] 334640 0
one year post commencement of intervention
Primary outcome [2] 335329 0
The primary outcome also aims to access the quality of life of asthma patients, with and without the involvement of pharmacists.
Specific name: Quality of life assessment of asthma patients with EQ5D-5L Questionnaire.
Objective Forms: Improvement in Quality of Life of asthma patients.
Instruments Used: Quality of life would be accessed through following questionnaire:
1. EQ5D-5L Questionnaire.
It is a health-related quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Principal investigator has already received approval for its legal use, through its copyright holders.
Timepoint [2] 335329 0
one year post commencement of intervention
Secondary outcome [1] 421493 0
The secondary outcome of this study is observe and compare the cost of treatment (hospitalization in case of acute asthma exacerbations) in asthmatic patients with and without the pharmacist involvement in selected hospitals.
Specific Name: Cost of treatment of asthma
Objective Form: The percentage of reduction in cost of treatment
Instruments used: Asthma Control would be assessed by following methods:
1. Number of hospital visits for acute asthma exacerbations
2. Cost of drugs for asthma management.
Timepoint [1] 421493 0
one year post commencement of intervention
Secondary outcome [2] 423965 0
The secondary outcome is to observe and compare the Adherence with medication of asthmatic patients with and without the involvement of pharmacists through MTM program for asthma, in selected hospitals.
Specific Name: Adherence with asthma medication
Objective Form: Improvement in adherence with asthma medication
Instruments used: Adherence would be assessed by self-developed questionnaire
Timepoint [2] 423965 0
One year post enrollment

Eligibility
Key inclusion criteria
I. Patients with asthma in selected three hospitals.
II. Patients with at least 3 visits to the hospital for follow-up.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant asthma patients

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)
Prospective randomized controlled study
Total sample size = 600 subjects
Total hospitals selected= 3 hospitals
Each hospital = 200 subjects
Each hospital control group = 100 study subjects
Each hospital interventional group = 100 study subjects

Total sampling population is 600 asthma patients for three different hospitals. Study subjects would be divided into two groups i.e., Control Group and Interventional Group.
A follow-up of One year will be conducted for both groups.

1. Control Group: It comprises of the adult asthma outpatients receiving treatment from asthma management clinics in three selected hospitals. It will include 50% of the total sample population i.e., 300 asthma patients.
2. Interventional Group: It comprises of the adult asthma outpatients receiving treatment from asthma management clinics along with the pharmacist led educational intervention (MTM for asthma program) in three selected hospitals. It will include 50% of the total sample population i.e., 300 asthma patients.

The method of allocation would include- central randomisation by Ms Excell (computer).
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
Safety/efficacy
Statistical methods / analysis
The data analysis will be done using the SPSS version 22. Descriptive date will be expressed as mean ± standard deviation (SD). Kolmogorov-Smirnov test (KS-test) will be applied to the collected data to check the normality of data. One-way ANOVA will be used for analysis of normally distributed variables. Kruskal-Wallis or Mann Whitney U will be used for non-normally distributed data. Categorical data will be analyzed using Chi-square or Fisher‘s exact test. A value of P < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
15/02/2025
Actual
Date of last data collection
Anticipated
15/04/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 25428 0
Pakistan
State/province [1] 25428 0
Punjab

Funding & Sponsors
Funding source category [1] 315703 0
Self funded/Unfunded
Name [1] 315703 0
Dr. Sara Shahid Department of Pharmacy Practice, Lahore Pharmacy College, Lahore Medical & Dental College, University of Health Sciences, Tulspura, Canal Rd, North, Lahore, Punjab, Pakistan.
Country [1] 315703 0
Pakistan
Primary sponsor type
Individual
Name
Sara Shahid
Address
House # 84 Street C Madni Block Hajvery Housing Scheme Harbanspura 140406, Lahore, Punjab, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 317807 0
Individual
Name [1] 317807 0
Fahad Ahmed Department of Pharmaceutics, University of Sargodha, Pakistan
Address [1] 317807 0
Country [1] 317807 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312934 0
Research Ethics Committee (REC) of Lahore Pharmacy College
Ethics committee address [1] 312934 0
Research Ethics Committee, Lahore Pharmacy College, Lahore Medical & Dental College, University of Health Sciences, Tulspura, Canal Road, North, Lahore - 534000, Punjab, Pakistan.
Ethics committee country [1] 312934 0
Pakistan
Date submitted for ethics approval [1] 312934 0
23/02/2023
Approval date [1] 312934 0
18/04/2023
Ethics approval number [1] 312934 0
LPC/ETH/27/2022

Summary
Brief summary
The main objective of the current study is to evaluate the effect of pharmacist led intervention in MTM services of different government hospitals in Punjab, Pakistan on clinical outcomes (Spirometry and number of acute asthma attacks) of asthma.

H0- Null Hypothesis:
MTM services in government hospitals of Punjab, Pakistan do not have a scientifically significant impact on clinical outcomes of Asthma.

H1- Alternate Hypothesis:
MTM services in government hospitals of Punjab, Pakistan have a scientifically significant impact on clinical outcomes of Asthma.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 126394 0
Dr Sara Shahid
Address 126394 0
Department of Pharmacy Practice, Lahore Pharmacy College, Lahore Medical & Dental College, University of Health Sciences, Tulspura, Canal Road, North Canal Bank, Lahore 53400, Punjab, Pakistan.
Country 126394 0
Pakistan
Phone 126394 0
+923202211770
Fax 126394 0
Email 126394 0
[email protected]
Contact person for public queries
Name 126395 0
Sara Shahid
Address 126395 0
Department of Pharmacy Practice, Lahore Pharmacy College, Lahore Medical & Dental College, University of Health Sciences, Tulspura, Canal Road, North Canal Bank, Lahore 53400, Punjab, Pakistan.
Country 126395 0
Pakistan
Phone 126395 0
+923202211770
Fax 126395 0
Email 126395 0
[email protected]
Contact person for scientific queries
Name 126396 0
Sara Shahid
Address 126396 0
Department of Pharmacy Practice, Lahore Pharmacy College, Lahore Medical & Dental College, University of Health Sciences, Tulspura, Canal Road, North Canal Bank, Lahore 53400, Punjab, Pakistan.
Country 126396 0
Pakistan
Phone 126396 0
+923202211770
Fax 126396 0
Email 126396 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?
The individual participant data that has been collected during the trial, after de-identification; individual participant data underlying published results only will be shared
When will data be available (start and end dates)?
Data will be available after results analysis in December 2026. The data would be available for 5 years
Available to whom?
Data would be available to researchers who provide a methodologically sound proposal for data availability to the Primary Sponsor
Available for what types of analyses?
Systematic reviews and meta analysis and any other analysis, only to achieve the aims in the approved proposal
How or where can data be obtained?
email and contact details provided by Principal Investigator.
Email: [email protected]
Contact number: +923202211770


What supporting documents are/will be available?




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.