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

NCT06227793 | Recruiting

• 1 other identifier: 20230013
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma control

  The degree of asthma control will be determined according to the Asthma Control Test (ACT). The questionnaire score ranges from 5 to 25 (higher scores indicate better control), with a score of 25 points expressing the best possible control. Scores from 20 to 25 are classified as controlled; 16-19 as not well controlled; and 5-15 as very poorly controlled asthma. The ACT consists of four questions about symptoms/relief and self-assessment of control by the patient. A clinically important minimum difference of 3 points is considered.

  3 years

Secondary Outcomes (6)

• Degree of adherence to treatment

  3 years

• Asthma Quality of Life Questionnaire

  3 years

• Lung function (spirometry)

  3 years

• Rates of exacerbations requiring oral corticosteroid use

  3 years

• Emergency room visits for asthma

  3 years

Study Arms (2)

intervention

EXPERIMENTAL

With health education

Behavioral: pharmaceutical intervention

control

NO INTERVENTION

Without health education

Interventions

pharmaceutical intervention BEHAVIORAL

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.

intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

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

• Paulo Dalcin

  Hospital Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Dalcin, Doctor

CONTACT

555133422439; pdalcin@hcpa.edu.br

Aline Nogare, Master

CONTACT

555133422439; anogare@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: August 14, 2023
• Primary Completion: August 31, 2025
• Study Completion: March 30, 2026
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)