Clinical trial NCT05503342: Monitoring of Patients With Asthma Performed by a Clinical Pharmacist Using a Mobile Application
Official title: Pharmacotherapy Follow-up of a Randomized Cohort to Monitor Patients With Asthma on Well-defined Treatment Using a Self-management Mobile Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Pharmaceutical Services
Pharmacists
Self-Management
Mobile Applications
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Federal University of Amazonas
First posted: 2022-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Asthma Control at 4 weeks
timeFrame: 4 weeks after the inclusion visit
measure: Change in Asthma Control at 12 weeks
timeFrame: 12 weeks after the inclusion visit
measure: Occurrence of exacerbations
timeFrame: Up to study completion, an average of 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clincias da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Rafael Stelmach
role: PRINCIPAL_INVESTIGATOR
References: