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

NCT06227793 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-01-29

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

pharmaceutical 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.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Paulo Dalcin · Hospital Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2025-08-31
Completion
2026-03-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227793 on ClinicalTrials.gov