AsthmaNCT06562764
To Evaluate Newly Developed Pictogram Cards and Their Utility in Improving Inhaler Techniques in Asthmatic Patients
A study testing Counselling by the Trained Pharmacist and Pictograms Cards and Counselling by the Trained Pharmacist in people with Asthma, run by Islamia University of Bahawalpur at 1 site in Pakistan.
Trial summary
To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Counselling by the Trained Pharmacist and Pictograms Cards and Counselling by the Trained Pharmacist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2024to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asthmatic Patients, should take inhalers regularly for at least 3 months and come personally for re-fill.
Who cannot join
- Coexistence of other chronic respiratory conditions.
- Those who were difficult to communicate.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Islamia University of Bahawalpur
Chak Eighty-seven -Twelve Left, Bahawalpur, 63100
About this study
Official title: Role of Pharmaceutical Pictograms in Disease Management: A Mix Method Study of Various Stakeholders in Pakistan
To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.
Read the detailed description
A prospective, open-label, randomized controlled clinical study. For this purpose, pictogram cards are designed for Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI).
The pictogram labels are designed and printed in colors with Urdu language and then attached to the inhaler devices as cards. The demographic, clinical, and medical data are collected from the patients and their medical files. Moreover, the different clinical measures are also evaluated in the recruited patients.
- Conditions
- Asthma
- Being tested
- Counselling by the Trained Pharmacist, Pictograms Cards and Counselling by the Trained Pharmacist
- Keywords
- Pictograms, MDI, DPI, Inhaler, Pictogram cards, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling by the Trained PharmacistOther
The intervention group 1 is verbally counselled about the proper use of their inhaler devices.
Pictograms Cards and Counselling by the Trained PharmacistOther
The investigator developed pictogram cards for the use of inhalers (MDI and DPI) and pictogram cards are attached to the inhalers of patients in the intervention group with counselling by the trained pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Controlled | No intervention | The control group is the set of subjects that do not receive the intervention in a study. |
| Counselling by the Trained Pharmacist | Experimental | The intervention group 1 is the set of subjects that receive the "counseling intervention" in a study. Receives: Other: Counselling by the Trained Pharmacist |
| Counselling and Pictograms | Experimental | Intervention group 2 consists of the subjects who receive the "counseling and pictogram intervention" in a study. Receives: Other: Pictograms Cards and Counselling by the Trained Pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper/Improper use of inhaler
Determine the proper/improper use of inhaler via checklist. The dichotomous primary endpoint (Proper inhaler technique/ Improper Inhaler Technique). A participant is categorized as having proper inhaler technique if the score was 7/7 and improper technique if the score was < 7.
Measured: 12 weeks
Secondary outcomes (2)
Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5).
Adherence is the extent to which a person's behavior- taking medication, following a diet, and/or executing lifestyle changes- corresponds with the agreed recommendations from a healthcare provider. The adherence is measured via a validated tool named the Medication Adherence Report Scale (MARS-5). MARS-5 shows promise as a self-report tool for measuring patients' reports of their medication use across various illnesses. The score ranges from 5 to 25, where a higher MARS-5 score indicates higher self-reported adherence.
Measured: 12 weeks
Determine the Asthma Control in the asthmatic patients via ACT questionnaire.
Asthma control is determined via ACT questionnaire. ACT scores range from 5-25 for the adult test and 0-27 for the child test. The higher the score, the better the asthma control. In both tests, a score of 20 or higher suggests your asthma is probably under control.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start10 May 2024
- Primary completion20 Jun 2024
- Study completion25 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanza Arshad, Islamia University of Bahawalpur
- Investigators
- Dr. Muhammad Atif, PhD, Study director, The Islamia University of Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562764
- Sponsor's protocol ID
- 668/AS&R
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD collected during the trial allowed by the research investigator, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pharmaceutical Pictograms in Disease Management: A Mix Method Study of Various Stakeholders in Pakistan
- ClinicalTrials.gov ID
- NCT06562764
- Acronym / sponsor ID
- 668/AS&R
- Conditions
- Asthma
- Keywords
- Pictograms, MDI, DPI, Inhaler, Pictogram cards, Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.
Detailed description
A prospective, open-label, randomized controlled clinical study. For this purpose, pictogram cards are designed for Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI).
The pictogram labels are designed and printed in colors with Urdu language and then attached to the inhaler devices as cards. The demographic, clinical, and medical data are collected from the patients and their medical files. Moreover, the different clinical measures are also evaluated in the recruited patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
| Arm | Type | Receives |
|---|---|---|
| Controlled | No intervention | –The control group is the set of subjects that do not receive the intervention in a study. |
| Counselling by the Trained Pharmacist | Experimental | Other: Counselling by the Trained PharmacistThe intervention group 1 is the set of subjects that receive the "counseling intervention" in a study. |
| Counselling and Pictograms | Experimental | Other: Pictograms Cards and Counselling by the Trained PharmacistIntervention group 2 consists of the subjects who receive the "counseling and pictogram intervention" in a study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asthmatic Patients, should take inhalers regularly for at least 3 months and come personally for re-fill.
Key exclusion criteria (2 listed)
- Coexistence of other chronic respiratory conditions.
- Those who were difficult to communicate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling by the Trained PharmacistThe intervention group 1 is verbally counselled about the proper use of their inhaler devices. | Other | Counselling by the Trained Pharmacist |
| Pictograms Cards and Counselling by the Trained PharmacistThe investigator developed pictogram cards for the use of inhalers (MDI and DPI) and pictogram cards are attached to the inhalers of patients in the intervention group with counselling by the trained pharmacist. | Other | Counselling and Pictograms |
Primary outcome
Proper/Improper use of inhaler
Time frame: 12 weeks
Determine the proper/improper use of inhaler via checklist. The dichotomous primary endpoint (Proper inhaler technique/ Improper Inhaler Technique). A participant is categorized as having proper inhaler technique if the score was 7/7 and improper technique if the score was < 7.
2 secondary outcomes
Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5).
Time frame: 12 weeks
Determine the Asthma Control in the asthmatic patients via ACT questionnaire.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Yes. The IPD collected during the trial allowed by the research investigator, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Muhammad Atif, PhD study director
The Islamia University of Bahawalpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling by the Trained Pharmacist and Pictograms Cards and Counselling by the Trained Pharmacist in people with Asthma, run by Islamia University of Bahawalpur at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proper/Improper use of inhaler (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.