RecruitingNot ApplicableNCT06227793

Pragmatic Clinical Trial to Assess the Effectiveness of Pharmaceutical Intervention in Patients With Uncontrolled Asthma

Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

76 participants

Start Date

Aug 14, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

The aim of this study is to evaluate the effectiveness of pharmaceutical intervention in controlling asthma in patients diagnosed with uncontrolled asthma. This is a pragmatic clinical trial composed of two groups - intervention (pharmaceutical monitoring) and control (without pharmaceutical monitoring). The study population will consist of patients with uncontrolled asthma, seen at the asthma outpatient clinic of the Hospital de Clínicas de Porto Alegre. Patients who agree to participate in the study will be randomized to the control group (managed by the specialized outpatient medical team) and the intervention group (in addition to management by the specialized medical team, they will be referred for pharmaceutical monitoring at the Clinical Research Center of the Hospital de Clínicas de Porto Alegre). The primary outcome of the study will be the proportion of patients with uncontrolled asthma who achieve an ACT \> 20 after a systematic educational intervention, guided by a pharmaceutical professional, compared to a group that does not receive this type of intervention.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

Age from 18 to 70 years.
Previous diagnosis of asthma according to clinical and pulmonary functional criteria, established in national and international guidelines.
Present uncontrolled asthma as assessed by the ACT (score below 20 points) (32).
Be undergoing outpatient treatment at the Pulmonology Service of HCPA for at least 6 months and have had at least 2 prior consultations.
Reside in Porto Alegre or in the metropolitan region of Porto Alegre.
Smoking index less than 10 pack-years (number of cigarettes smoked per day / 20 cigarettes x number of years of smoking).

Exclusion Criteria6

Pregnant patients
Chronic neurological or psychiatric diseases that prevent the execution of study procedures
Pulmonary comorbidities such as chronic obstructive pulmonary disease, diffuse bronchiectasis, extensive sequelae of tuberculosis, diffuse pulmonary fibrosis.
Lung neoplasms or from other sites.
Incapacitating cardiovascular diseases
Patients without access to WhatsApp.

Interventions

BEHAVIORALpharmaceutical intervention

Individuals randomized to the intervention group will undergo monthly pharmaceutical consultations for health education, initiated after randomization. There will be three in-person consultations, starting in month 1 with monthly spacing, scheduled by the pharmacist in the office, except for the first consultation, which will be scheduled by the pharmacist over the phone after randomization. These consultations will be part of the intervention study's educational process and will take place between the initial and final assessments. The educational process scripts for each consultation include a pharmaceutical follow-up form and an inhalation technique assessment form. Once the consultation is completed, the patient will also receive, via WhatsApp and/or email according to their preference, an educational video demonstrating the step-by-step inhalation technique based on their prescribed treatment.