Bronchial AsthmaNCT06233123
Efficacy of a Phone Application on Treatment Adherence in Asthmatic Patients in Upper Egypt
A study testing the Medisafe android application (https://www.medisafe.com). in people with Bronchial Asthma and Adherence, Medication, run by Assiut University.
Trial summary
asthma adherence is mandatory for disease control Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bronchial Asthma, Adherence, Medication
- What is being tested?
- the Medisafe android application (https://www.medisafe.com).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Mar 2025
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Doctor-diagnosed asthma. On at least Global Initiative for Asthma (GINA) step 3 which means they will be on regular inhaled steroids.
- No change in regular asthma treatment in the last 1 month Sufficient English-language ability to understand the text in mobile phone-delivered interventions The education level required will be at least a high school diploma.
Who cannot join
- GINA step 5 asthma (complex issues, too unstable). Recent changes to asthma treatment within the last month Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis) Patients without mobile device skills
Trial locations and contacts
No sites are listed yet.
About this study
asthma adherence is mandatory for disease control
Read the detailed description
Asthma is a chronic and common disease of the airways that affects more than 339 million people globally [1]. According to WHO estimates, there were 417,918 deaths due to asthma at the global level and 24.8 million disability-adjusted life years (DALYs) attributable to Asthma [2, 3]. There is much evidence that self-care by patients with asthma has beneficial outcomes, including reduced hospital stays, reduced symptoms, and general compliance with treatments [4-6]. One of the approaches for promoting self-care skills in patients with asthma is to provide self-care services (i.e., providing basic information about the nature of asthma, avoiding exposure to allergens and triggers, treating with drugs, providing alerts and reminders to patients, and how to use the therapeutic tools [7]) through information technology tools (e.g. the Internet, mobile phones, and computer software). Given the increasing worldwide use of smartphones, mobile health (mHealth) technologies can work as promising tools to improve self-care in patients with asthma by providing support services such as communication information, providing learning materials, and sending reminders for behavior change [8, 9]. mHealth, as a component of electronic health, is related to the use of mobile phones and other wireless technologies to improve the provision of health-related services. Moreover, ease of use, portability, and ubiquity in all regions are the potential benefits of mHealth tools for the prevention, diagnosis, treatment, and care of diseases also increasing access to health services and reducing the costs incurred [10]. This study aims to evaluate the role of a mobile application in reminding the patient to take his treatment and its reflection on asthma control and quality of life.
- Conditions
- Bronchial Asthma, Adherence, Medication
- Being tested
- the Medisafe android application (https://www.medisafe.com).
- 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.
the Medisafe android application (https://www.medisafe.com).Behavioural
Also called Artificial intelligence, mobile application, phone application
software for Android mobile phones that can remind the patient of his treatment on time
| Study group | Role | What they receive |
|---|---|---|
| Application | Experimental | intervention group that will download the Medisafe android application (https://www.medisafe.com). This mobile application uses simple English language and figures to remind the patient about the dose Receives: Behavioral: the Medisafe android application (https://www.medisafe.com). |
| control | No intervention | control group with Standard Care and Medication Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control after 3 months
asthma control test after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Hsanen, Assiut University
- Investigators
- Entsar H Mohamed, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233123
- Sponsor's protocol ID
- asthma adherence phone
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1.Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. 2017;390(10100):1211-59. 2.World Health Organisation. Global health estimates 2016: deaths by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organization; 2018a. 3.World Health Organisation. Global health estimates 2016: disease burden by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organization; 2018b. 4.Levy M, Andrews R, Buckingham R, et al. Why asthma still kills: the National Review of Asthma Deaths (NRAD). London: Royal College of Physcians; 2014. 5.James DR, Lyttle MD. British guideline on the management of asthma: SIGN Clinical Guideline 141, 2014. Arch Dis Child Educ Pract. 2016;101(6):319-22.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Phone Application on Treatment Adherence in Asthmatic Patients in Upper Egypt
- ClinicalTrials.gov ID
- NCT06233123
- Acronym / sponsor ID
- asthma adherence phone
- Conditions
- Bronchial Asthma, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 31 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.
asthma adherence is mandatory for disease control
Detailed description
Asthma is a chronic and common disease of the airways that affects more than 339 million people globally [1]. According to WHO estimates, there were 417,918 deaths due to asthma at the global level and 24.8 million disability-adjusted life years (DALYs) attributable to Asthma [2, 3]. There is much evidence that self-care by patients with asthma has beneficial outcomes, including reduced hospital stays, reduced symptoms, and general compliance with treatments [4-6]. One of the approaches for promoting self-care skills in patients with asthma is to provide self-care services (i.e., providing basic information about the nature of asthma, avoiding exposure to allergens and triggers, treating with drugs, providing alerts and reminders to patients, and how to use the therapeutic tools [7]) through information technology tools (e.g. the Internet, mobile phones, and computer software). Given the increasing worldwide use of smartphones, mobile health (mHealth) technologies can work as promising tools to improve self-care in patients with asthma by providing support services such as communication information, providing learning materials, and sending reminders for behavior change [8, 9]. mHealth, as a component of electronic health, is related to the use of mobile phones and other wireless technologies to improve the provision of health-related services. Moreover, ease of use, portability, and ubiquity in all regions are the potential benefits of mHealth tools for the prevention, diagnosis, treatment, and care of diseases also increasing access to health services and reducing the costs incurred [10]. This study aims to evaluate the role of a mobile application in reminding the patient to take his treatment and its reflection on asthma control and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application | Experimental | Behavioral: the Medisafe android application (https://www.medisafe.com).intervention group that will download the Medisafe android application (https://www.medisafe.com). This mobile application uses simple English language and figures to remind the patient about the dose |
| control | No intervention | –control group with Standard Care and Medication Monitoring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Doctor-diagnosed asthma. On at least Global Initiative for Asthma (GINA) step 3 which means they will be on regular inhaled steroids.
- No change in regular asthma treatment in the last 1 month Sufficient English-language ability to understand the text in mobile phone-delivered interventions The education level required will be at least a high school diploma.
Key exclusion criteria (1 listed)
- GINA step 5 asthma (complex issues, too unstable). Recent changes to asthma treatment within the last month Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis) Patients without mobile device skills
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 |
|---|---|---|
| the Medisafe android application (https://www.medisafe.com).Also: Artificial intelligence, mobile application, phone applicationsoftware for Android mobile phones that can remind the patient of his treatment on time | Behavioural | Application |
Primary outcome
Asthma control after 3 months
Time frame: 3 months
asthma control test after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background1.Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. 2017;390(10100):1211-59. 2.World Health Organisation. Global health estimates 2016: deaths by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organization; 2018a. 3.World Health Organisation. Global health estimates 2016: disease burden by cause, age, sex, by country and by region, 2000-2016. Geneva: World Health Organization; 2018b. 4.Levy M, Andrews R, Buckingham R, et al. Why asthma still kills: the National Review of Asthma Deaths (NRAD). London: Royal College of Physcians; 2014. 5.James DR, Lyttle MD. British guideline on the management of asthma: SIGN Clinical Guideline 141, 2014. Arch Dis Child Educ Pract. 2016;101(6):319-22.
- Individual participant dataSharing planned: Undecided
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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?
A study testing the Medisafe android application (https://www.medisafe.com). in people with Bronchial Asthma and Adherence, Medication, run by Assiut University.
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 2 inclusion and 1 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 31 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 (01019968106, 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?
Asthma control after 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06233123, which also lists 1 linked publication.
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 31 Jan 2024.