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

NCT ID: NCT05503342

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-29
• Study Completion Date: 2022-04-23

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

Asthma control assessment

Intervention Type: OTHER

Asthma control assessment questionnaire application in paper format

Application

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.

Group Type: EXPERIMENTAL

Mobile Application

Intervention Type: OTHER

Use of the cell phone application to include information about asthma symptoms which had returned with guidance on self-management.

Interventions

Mobile Application

Use of the cell phone application to include information about asthma symptoms which had returned with guidance on self-management.

Intervention Type: OTHER

Asthma control assessment

Asthma control assessment questionnaire application in paper format

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Amazonas

OTHER

Sponsor Role: collaborator

Rafael Stelmach

OTHER

Sponsor Role: lead

Responsible Party

Rafael Stelmach

Collaborating Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rafael Stelmach

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

Hospital das Clincias da Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

SDC - 4874/19/093

Identifier Type: -

Identifier Source: org_study_id