Bronchial AsthmaNCT06200623
Cognitive and Emotional Factors Relation to Treatment Adherence in Asthmatic Patients in Upper Egypt
An observational study of Bronchial Asthma and Adherence, Medication, run by Entsar Hsanen.
Trial summary
Non-adherence to controller therapy is one of the main reasons of poor asthma control. Adherence to medication in different studies range between 30 and 70% . Several factors related to the disease, to the patient, treatment or physician- patient relationship Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma, Adherence, Medication
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 138 asthmatic patients presented to respiratory outpatient clinic
Who may be able to join
- Able to understand and provide informed consent.
- Age ≥18y at the time of study enrollment.
- Provider diagnosed asthma and prescribed maintenance ICS treatment and as needed bronchodilator for at least one month
Who cannot join
- Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
- Severe psychopathology (e.g., schizophrenia)
- Apparent cognitive or language deficit
- Patients with associated other chronic chest diseases
Trial locations and contacts
No sites are listed yet.
About this study
Non-adherence to controller therapy is one of the main reasons of poor asthma control. Adherence to medication in different studies range between 30 and 70% . Several factors related to the disease, to the patient, treatment or physician- patient relationship
Read the detailed description
Non-adherence to controller therapy is one of the main reasons for poor asthma control. Adherence to medication in different studies ranges between 30 and 70%. Several factors related to the disease, to the patient, treatment, or physician-patient relationship have been identified to be related to adherence in asthma and other diseases. According to the self-regulation theory, medication beliefs and illness perception are associated with treatment adherence. Beliefs about illness, the necessity, and the concerns (addition and side effects) of the treatment have been identified as the two most important elements in the proposed theory. Other factors that impact treatment adherence are the perceived efficacy of medicines, cost of therapy, complex dosing regimens, Patient's level of education, and cultural beliefs. Evaluating the beliefs about asthma medication, and cognitive and emotional perceptions may help to identify patients with poor adherence to treatment in clinical practice. That would guide additional attention helping to increase the likelihood of taking asthma medication appropriately. However, only limited information is available on treatment adherence in Egyptian people especially in upper Egypt. Furthermore, evidence identifying medication beliefs, and cognitive or emotional factors associated with asthma medication adherence among Egyptian people in upper Egypt is currently not available
- Conditions
- Bronchial Asthma, Adherence, Medication
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic patients presented to respiratory outpatient clinic | All subjects will be subjected to Complete history taking including demographic data, residence, educational level, income level, and presence of first- or second-degree medical relative. The first onset age of asthma and duration of asthma will be recorded. Factors that can affect treatment adherence are collected as type and number of medications, cost, inclusion in the health insurance system, availability, asthma-related comorbidities, and choice of drug and device. : To assess adherence we will use the Morisky Medication Adherence Scale (MMAS-8) as discussed above To assess patient beliefs, we will use The Beliefs about Medicines Questionnaire as discussed above To obtain information on illness perception we will use The Brief Illness Perception Questionnaire (Brief IPQ) as discussed above To assess asthma control we will use the asthma control test as discussed above |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence in asthmatic patients in upper Egypt and association to disease beliefs
simple questionnaires will be used to assess adherence, beliefs, and perception
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entsar Hsanen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Entsar Hsanen, Assiut University
- Investigators
- Entsar H Mohamed, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200623
- Sponsor's protocol ID
- Cognitive and emotional factor
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotional Factors Relation to Treatment Adherence in Asthmatic Patients in Upper Egypt
- ClinicalTrials.gov ID
- NCT06200623
- Acronym / sponsor ID
- Cognitive and emotional factor
- Conditions
- Bronchial Asthma, Adherence, Medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Entsar HsanenUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Jan 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.
Non-adherence to controller therapy is one of the main reasons of poor asthma control. Adherence to medication in different studies range between 30 and 70% . Several factors related to the disease, to the patient, treatment or physician- patient relationship
Detailed description
Non-adherence to controller therapy is one of the main reasons for poor asthma control. Adherence to medication in different studies ranges between 30 and 70%. Several factors related to the disease, to the patient, treatment, or physician-patient relationship have been identified to be related to adherence in asthma and other diseases. According to the self-regulation theory, medication beliefs and illness perception are associated with treatment adherence. Beliefs about illness, the necessity, and the concerns (addition and side effects) of the treatment have been identified as the two most important elements in the proposed theory. Other factors that impact treatment adherence are the perceived efficacy of medicines, cost of therapy, complex dosing regimens, Patient's level of education, and cultural beliefs. Evaluating the beliefs about asthma medication, and cognitive and emotional perceptions may help to identify patients with poor adherence to treatment in clinical practice. That would guide additional attention helping to increase the likelihood of taking asthma medication appropriately. However, only limited information is available on treatment adherence in Egyptian people especially in upper Egypt. Furthermore, evidence identifying medication beliefs, and cognitive or emotional factors associated with asthma medication adherence among Egyptian people in upper Egypt is currently not available
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatic patients presented to respiratory outpatient clinic | – | –All subjects will be subjected to Complete history taking including demographic data, residence, educational level, income level, and presence of first- or second-degree medical relative. The first onset age of asthma and duration of asthma will be recorded. Factors that can affect treatment adherence are collected as type and number of medications, cost, inclusion in the health insurance system, availability, asthma-related comorbidities, and choice of drug and device. : To assess adherence we will use the Morisky Medication Adherence Scale (MMAS-8) as discussed above To assess patient beliefs, we will use The Beliefs about Medicines Questionnaire as discussed above To obtain information on illness perception we will use The Brief Illness Perception Questionnaire (Brief IPQ) as discussed above To assess asthma control we will use the asthma control test as discussed above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 138 asthmatic patients presented to respiratory outpatient clinic
Key inclusion criteria (3 listed)
- Able to understand and provide informed consent.
- Age ≥18y at the time of study enrollment.
- Provider diagnosed asthma and prescribed maintenance ICS treatment and as needed bronchodilator for at least one month
Key exclusion criteria (4 listed)
- Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
- Severe psychopathology (e.g., schizophrenia)
- Apparent cognitive or language deficit
- Patients with associated other chronic chest diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment adherence in asthmatic patients in upper Egypt and association to disease beliefs
Time frame: one year
simple questionnaires will be used to assess adherence, beliefs, and perception
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Entsar H Mohamed, Lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma and Adherence, Medication, run by Entsar Hsanen.
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 3 inclusion and 4 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Entsar H Mohamed, lecturer (+201019968106, entsar.hsanen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence in asthmatic patients in upper Egypt and association to disease beliefs (time frame: one year). 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 Jan 2024.