Asthmatic PatientsPLET-INCT06863285
Asthma Control Through Telemedicine
A study testing Educational in people with Asthmatic Patients, run by Hamdard University at 1 site in Pakistan.
Trial summary
The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence. Pharmacist's intervention aims to answer: 1. How a pharmacist intervention program impact medication adherence in persistent asthma? 2. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Asthmatic Patients
- What is being tested?
- Educational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age above 11 years.
- Persistent Asthma Patient.
- Patients taking medications and inhaler.
- Patient who will consent for the study.
- Patient with basic telecommunication facility.
- Patient who responded to messages and calls.
Who cannot join
- Patients who will refuse to participate in study will not be included.
- Irresponsive patients to messages and calls
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Pharmacist Led Educational Interventions Through Telemedicine to Improve Asthma Control: a Randomized Control Trial
The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence.
Pharmacist's intervention aims to answer:
- How a pharmacist intervention program impact medication adherence in persistent asthma?
- To assess how pharmacist led educational intervention like patients' counseling and medication reminders through Telemedicine have an impact on patient's asthma control?
- Which mode of communication (Verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.
Read the detailed description
This is a randomized, pharmacist-led, two-group, longitudinal descriptive interventional study performed through in person (Public and private hospitals) and telecommunication (WhatsApp, network calls and messaging). The investigator will use snowball method to approach patients through telecommunication. Recruited patients will be randomly divided into two groups: the Control and the experimental group. The Control Group will not receive any intervention, and experimental group will receive special counseling about persistent asthma, it's medications and medical devices, their appropriate use, and side effects. Using Telemedicine as message and call reminders to increase medication adherence and improve their asthmatic condition. The intervention will be conducted for one month on the experimental group according to the recruitment date and time of the patients.
Pre-validated questionnaires will be used for the assessment
- The adherence to asthma medication questionnaire (AAMQ-13).
- Asthma Control test TM (ACT).
- Conditions
- Asthmatic Patients
- Being tested
- Educational
- Keywords
- Asthma, Telemedicine, pharmacist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalOther
intervention included the usual counselling by pharmacist e.g. Patients Education regarding Medications
- Pharmacist counseling patients regarding their disease and severity
- Pharmacist counseling (5- to 10-minute sessions) on the proper and safe use of medication.
- Pharmacist counseling patients regarding the importance of their therapy (treatment), non-pharmacological treatment like diet and exercises. pharmacist counselling regarding the preventive measures that prevent patient from triggers that can initiate asthmatic attacks.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | intervention included the usual counselling by pharmacist e.g. Patients Education regarding Medications
* Pharmacist counseling patients regarding their disease and severity
* Pharmacist counseling (5- to 10-minute sessions) on the proper and safe use of medication.
* Pharmacist counseling patients regarding the importance of their therapy (treatment), non-pharmacological treatment like diet and exercises.
pharmacist counselling regarding the preventive measures that prevent patient from triggers that can initiate asthmatic attacks. Receives: Other: Educational |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Score
Patient health related outcomes that is level of asthma control is measured by pre-validated tool Asthma Control test TM (ACT).
The Asthma Control Test™ assess responsiveness to changes in asthma control over time.
The tool has 5 questions with each having options with scores 1,2,3,4, and 5. A SCORE OF 19 OR LESS might be a warning of the need for further evaluation to determine whether adjustments to asthma treatment regimens or other measures are required to improve asthma control. If score is 15 or less, asthma may be poorly controlled or not controlled at all.
Measured: 1 month
Patients Medication Adherence Score
The primary aim of this study will be to evaluate the effectiveness/impact of a pharmacist educational intervention on medication adherence in Asthmatic patients.
Adherence will be measured using the adherence to asthma medication questionnaire (AAMQ-13 The AAMQ-13 is a reliable and valid questionnaire with several desirable characteristics as it has a high internal validity, good criterion validity, and strong construct validity. The AAMQ-13 is a suitable questionnaire that can identify non-adherent patients and reveal the reasons behind their non-adherence (intentional or unintentional non-adherence). Each question has Always, Often, sometimes, rarely and never response with scores allotted as 1,2,3,4 and 5 respectively, Score interpretation is as follows for the given tool Poor adherence Score= 13-29 Moderate adherence Score= 30-47 Excellent adherence= 48-65
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthmatic PatientsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Abubakar, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863285
- Sponsor's protocol ID
- ABJan012025
- Acronym
- PLET-I
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participant's identity is to be kept strictly confidential as per consent form that will be prepared for the study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacist Led Educational Interventions Through Telemedicine to Improve Asthma Control: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06863285
- Acronym / sponsor ID
- PLET-I / ABJan012025
- Conditions
- Asthmatic Patients
- Keywords
- Asthma, Telemedicine, pharmacist
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 7 Mar 2025 (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.
The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence.
Pharmacist's intervention aims to answer:
- How a pharmacist intervention program impact medication adherence in persistent asthma?
- To assess how pharmacist led educational intervention like patients' counseling and medication reminders through Telemedicine have an impact on patient's asthma control?
- Which mode of communication (Verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.
Detailed description
This is a randomized, pharmacist-led, two-group, longitudinal descriptive interventional study performed through in person (Public and private hospitals) and telecommunication (WhatsApp, network calls and messaging). The investigator will use snowball method to approach patients through telecommunication. Recruited patients will be randomly divided into two groups: the Control and the experimental group. The Control Group will not receive any intervention, and experimental group will receive special counseling about persistent asthma, it's medications and medical devices, their appropriate use, and side effects. Using Telemedicine as message and call reminders to increase medication adherence and improve their asthmatic condition. The intervention will be conducted for one month on the experimental group according to the recruitment date and time of the patients.
Pre-validated questionnaires will be used for the assessment
- The adherence to asthma medication questionnaire (AAMQ-13).
- Asthma Control test TM (ACT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Educationalintervention included the usual counselling by pharmacist e.g. Patients Education regarding Medications * Pharmacist counseling patients regarding their disease and severity * Pharmacist counseling (5- to 10-minute sessions) on the proper and safe use of medication. * Pharmacist counseling patients regarding the importance of their therapy (treatment), non-pharmacological treatment like diet and exercises. pharmacist counselling regarding the preventive measures that prevent patient from triggers that can initiate asthmatic attacks. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 11 years.
- Persistent Asthma Patient.
- Patients taking medications and inhaler.
- Patient who will consent for the study.
- Patient with basic telecommunication facility.
Key exclusion criteria (2 listed)
- Patients who will refuse to participate in study will not be included.
- Irresponsive patients to messages and calls
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 |
|---|---|---|
| Educationalintervention included the usual counselling by pharmacist e.g. Patients Education regarding Medications * Pharmacist counseling patients regarding their disease and severity * Pharmacist counseling (5- to 10-minute sessions) on the proper and safe use of medication. * Pharmacist counseling patients regarding the importance of their therapy (treatment), non-pharmacological treatment like diet and exercises. pharmacist counselling regarding the preventive measures that prevent patient from triggers that can initiate asthmatic attacks. | Other | Study group |
Primary outcome
Asthma Control Score
Time frame: 1 month
Patient health related outcomes that is level of asthma control is measured by pre-validated tool Asthma Control test TM (ACT). The Asthma Control Test™ assess responsiveness to changes in asthma control over time. The tool has 5 questions with each having options with scores 1,2,3,4, and 5. A SCORE OF 19 OR LESS might be a warning of the need for further evaluation to determine whether adjustments to asthma treatment regimens or other measures are required to improve asthma control. If score is 15 or less, asthma may be poorly controlled or not controlled at all.
Patients Medication Adherence Score
Time frame: 1 month
The primary aim of this study will be to evaluate the effectiveness/impact of a pharmacist educational intervention on medication adherence in Asthmatic patients. Adherence will be measured using the adherence to asthma medication questionnaire (AAMQ-13 The AAMQ-13 is a reliable and valid questionnaire with several desirable characteristics as it has a high internal validity, good criterion validity, and strong construct validity. The AAMQ-13 is a suitable questionnaire that can identify non-adherent patients and reveal the reasons behind their non-adherence (intentional or unintentional non-adherence). Each question has Always, Often, sometimes, rarely and never response with scores allotted as 1,2,3,4 and 5 respectively, Score interpretation is as follows for the given tool Poor adherence Score= 13-29 Moderate adherence Score= 30-47 Excellent adherence= 48-65
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No. The participant's identity is to be kept strictly confidential as per consent form that will be prepared for the study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational in people with Asthmatic Patients, run by Hamdard University 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 6 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MUhammad Abubakar, PhD (+923237166544, mabubakar.pharmacist@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Score (time frame: 1 month). The study lists 2 primary outcomes in all. 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 11 Mar 2025.