Monitoring of Patients With Asthma Performed by a Clinical Pharmacist Using a Mobile Application

Rafael Stelmach

Status: Completed

Conditions: Asthma

Treatments: Other: Asthma control assessment; Other: Mobile Application

Study type: Interventional

Funder types: Other

Identifiers

NCT05503342

SDC - 4874/19/093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Other: Asthma control assessment

Application

Experimental group

Description:

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.

Treatment:

Other: Mobile Application