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Completed

NCT Number: NCT05503342

Monitoring of Patients With Asthma Performed by a Clinical Pharmacist Using a 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile application

Other

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

Asthma control assessment

Other

Asthma control assessment questionnaire application in paper format

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

Rafael Stelmach

Other

Collaborators

  • Federal University of Amazonas

Registry information

Official study title

Pharmacotherapy Follow-up of a Randomized Cohort to Monitor Patients With Asthma on Well-defined Treatment Using a Self-management Mobile Application

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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