AsthmaNCT05503342
Monitoring of Patients With Asthma Performed by a Clinical Pharmacist Using a Mobile Application
A study testing Mobile Application in people with Asthma, run by Rafael Stelmach at 1 site in Brazil.
Trial summary
Asthma is a chronic inflammatory disease that affects the lungs. In Brazil it is responsible for about 4 to 8 deaths per day. Pharmacotherapeutic follow-up programs for people with asthma have a positive impact on treatment adherence, as well as on education about the disease, helping patients in their self-management… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Nov 2019to 23 Apr 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of asthma and being under medical follow-up for at least six months;
- Meet at least one of the following criteria: a) Have had at least one (01) exacerbation in the last 12 months; b) Have used oral corticosteroids in the last three months; and/or c) Being using high doses of inhaled corticosteroid (budesonide > 800 mcg/day; fluticasone > 500 mcg/day; or beclomethasone > 400 mcg/day - pressurized HFA gas-based device or >1000 mcg/day - other devices).
- Understand, agree and sign the Free and Informed Consent Term.
Who cannot join
- Illiterate patients or patients with cognitive deficits;
- Patients not fluent in Portuguese;
- Patients without mobile device skills;
- Patients who do not have mobile devices with Android® 6.0 operating system.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clincias da Faculdade de Medicina da Universidade de São Paulo
São Paulo
About this study
Official title: Pharmacotherapy Follow-up of a Randomized Cohort to Monitor Patients With Asthma on Well-defined Treatment Using a Self-management Mobile Application
Asthma is a chronic inflammatory disease that affects the lungs. In Brazil it is responsible for about 4 to 8 deaths per day. Pharmacotherapeutic follow-up programs for people with asthma have a positive impact on treatment adherence, as well as on education about the disease, helping patients in their self-management and recognition of their health status. The use of mobile applications that assist in the monitoring and self-management of people with asthma has been increasing significantly, but we do not have much information about their real impact on the control of the disease. Thus, the aim of this study is to evaluate the use of a mobile application in the monitoring and self-management of symptoms in adults with asthma in a pharmaceutical care program at a university outpatient clinic in São Paulo, Brazil.
Read the detailed description
Study design: interventional study
Patients will be selected according to eligibility criteria and after having agreed and signed an informed consent form, they will be randomized into one of the arms of the study.
At the inclusion visit, demographic data, health history, medication history and allergy history will be collected. They will be evaluated regarding the level of asthma control using the ACQ-6 instrument, as well as the ability to use inhaled medications. They will receive the relevant guidelines regarding the activities that will be carried out during the study.
In both arms, patients will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record weekly three measurements of peak expiratory flow and fill out a questionnaire to assess the control on paper (control group) or fill out a risk score for exacerbation contemplated in the mobile application, which the pharmacist will have access through a web platform (intervention group). Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable.
During the study, a follow-up visit will be carried out and, at the end of the 12 weeks, a closing visit, where will be evaluated the need for medical support during the period, the use of systemic corticosteroids, access to control treatment, the occurrence of adverse event, review of pharmacotherapy and inhalation technique.
- Conditions
- Asthma
- Being tested
- Mobile Application, Asthma control assessment
- Keywords
- Asthma, Pharmaceutical Services, Pharmacists, Self-Management, Mobile Applications
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationOther
Use of the cell phone application to include information about asthma symptoms which had returned with guidance on self-management.
Asthma control assessmentOther
Asthma control assessment questionnaire application in paper format
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | They will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record three measurements of peak expiratory flow weekly and fill out a questionnaire to assess control on paper.
Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable. Receives: Other: Asthma control assessment |
| Application | Experimental | They will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record three measurements of peak expiratory flow weekly and fill in an exacerbation risk score included in the cell phone application, which the pharmacist will have access to through a web platform. Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable. Receives: Other: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Asthma Control at 4 weeks
The evolution of asthma control will be evaluated through repeated measures of a validated control assessment questionnaire (control arm) or by the risk of exacerbation score contemplated in the cell phone application (application arm)
Measured: 4 weeks after the inclusion visit
Change in Asthma Control at 12 weeks
The evolution of asthma control will be evaluated through repeated measures of a validated control assessment questionnaire (control arm) or by the risk of exacerbation score contemplated in the cell phone application (application arm)
Measured: 12 weeks after the inclusion visit
Occurrence of exacerbations
Assessment of the number of occurrences of severe exacerbations that required medical support.
Measured: Up to study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start29 Nov 2019
- Primary completion23 Apr 2022
- Study completion23 Apr 2022
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
- In both arms, patients will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record weekly three measurements of peak expiratory flow and fill out a questionnaire to assess the control on paper (control group) or fill out a risk score for exacerbation contemplated in the mobile application, which the pharmacist will have access through a web platform (intervention group). Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafael Stelmach
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Amazonas
- Responsible party
- Sponsor-investigator, Rafael Stelmach, University of Sao Paulo General Hospital
- Investigators
- Rafael Stelmach, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503342
- Sponsor's protocol ID
- SDC - 4874/19/093
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy Follow-up of a Randomized Cohort to Monitor Patients With Asthma on Well-defined Treatment Using a Self-management Mobile Application
- ClinicalTrials.gov ID
- NCT05503342
- Acronym / sponsor ID
- SDC - 4874/19/093
- Conditions
- Asthma
- Keywords
- Asthma, Pharmaceutical Services, Pharmacists, Self-Management, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rafael StelmachUniversity, hospital or other
- Collaborators
- Federal University of Amazonas
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 16 Aug 2022 (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 is a chronic inflammatory disease that affects the lungs. In Brazil it is responsible for about 4 to 8 deaths per day. Pharmacotherapeutic follow-up programs for people with asthma have a positive impact on treatment adherence, as well as on education about the disease, helping patients in their self-management and recognition of their health status. The use of mobile applications that assist in the monitoring and self-management of people with asthma has been increasing significantly, but we do not have much information about their real impact on the control of the disease. Thus, the aim of this study is to evaluate the use of a mobile application in the monitoring and self-management of symptoms in adults with asthma in a pharmaceutical care program at a university outpatient clinic in São Paulo, Brazil.
Detailed description
Study design: interventional study
Patients will be selected according to eligibility criteria and after having agreed and signed an informed consent form, they will be randomized into one of the arms of the study.
At the inclusion visit, demographic data, health history, medication history and allergy history will be collected. They will be evaluated regarding the level of asthma control using the ACQ-6 instrument, as well as the ability to use inhaled medications. They will receive the relevant guidelines regarding the activities that will be carried out during the study.
In both arms, patients will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record weekly three measurements of peak expiratory flow and fill out a questionnaire to assess the control on paper (control group) or fill out a risk score for exacerbation contemplated in the mobile application, which the pharmacist will have access through a web platform (intervention group). Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable.
During the study, a follow-up visit will be carried out and, at the end of the 12 weeks, a closing visit, where will be evaluated the need for medical support during the period, the use of systemic corticosteroids, access to control treatment, the occurrence of adverse event, review of pharmacotherapy and inhalation technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In both arms, patients will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record weekly three measurements of peak expiratory flow and fill out a questionnaire to assess the control on paper (control group) or fill out a risk score for exacerbation contemplated in the mobile application, which the pharmacist will have access through a web platform (intervention group). Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Asthma control assessmentThey will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record three measurements of peak expiratory flow weekly and fill out a questionnaire to assess control on paper. Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable. |
| Application | Experimental | Other: Mobile ApplicationThey will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record three measurements of peak expiratory flow weekly and fill in an exacerbation risk score included in the cell phone application, which the pharmacist will have access to through a web platform. Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a diagnosis of asthma and being under medical follow-up for at least six months;
- Meet at least one of the following criteria: a) Have had at least one (01) exacerbation in the last 12 months; b) Have used oral corticosteroids in the last three months; and/or c) Being using high doses of inhaled corticosteroid (budesonide > 800 mcg/day; fluticasone > 500 mcg/day; or beclomethasone > 400 mcg/day - pressurized HFA gas-based device or >1000 mcg/day - other devices).
- Understand, agree and sign the Free and Informed Consent Term.
Key exclusion criteria (4 listed)
- Illiterate patients or patients with cognitive deficits;
- Patients not fluent in Portuguese;
- Patients without mobile device skills;
- Patients who do not have mobile devices with Android® 6.0 operating system.
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 |
|---|---|---|
| Mobile ApplicationUse of the cell phone application to include information about asthma symptoms which had returned with guidance on self-management. | Other | Application |
| Asthma control assessmentAsthma control assessment questionnaire application in paper format | Other | Control |
Primary outcome
Change in Asthma Control at 4 weeks
Time frame: 4 weeks after the inclusion visit
The evolution of asthma control will be evaluated through repeated measures of a validated control assessment questionnaire (control arm) or by the risk of exacerbation score contemplated in the cell phone application (application arm)
Change in Asthma Control at 12 weeks
Time frame: 12 weeks after the inclusion visit
The evolution of asthma control will be evaluated through repeated measures of a validated control assessment questionnaire (control arm) or by the risk of exacerbation score contemplated in the cell phone application (application arm)
Occurrence of exacerbations
Time frame: Up to study completion, an average of 12 weeks
Assessment of the number of occurrences of severe exacerbations that required medical support.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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.
Rafael Stelmach principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Asthma, run by Rafael Stelmach at 1 site in Brazil.
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: finished, as of the sponsor's last update on 16 Aug 2022. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Asthma Control at 4 weeks (time frame: 4 weeks after the inclusion visit). The study lists 3 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 16 Aug 2022.