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

NCT05503342 | Completed

• 1 other identifier: SDC - 4874/19/093
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Pharmaceutical Services; Pharmacists; Self-Management; Mobile Applications

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  12 weeks after the inclusion visit

• Occurrence of exacerbations

  Assessment of the number of occurrences of severe exacerbations that required medical support.

  Up to study completion, an average of 12 weeks

Study Arms (2)

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.

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.

Other: Mobile Application

Interventions

Mobile Application OTHER

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

Application

Asthma control assessment OTHER

Asthma control assessment questionnaire application in paper format

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rafael Stelmach: lead
• Federal University of Amazonas: collaborator

Study Sites (1)

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

São Paulo, Brazil

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rafael Stelmach

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Collaborating Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 16, 2022
• Study Start: November 29, 2019
• Primary Completion: April 23, 2022
• Study Completion: April 23, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)