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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: pharmaceutical intervention

Detailed Description

Asthma is a heterogeneous disease, typically characterized by chronic inflammation of the airways. Uncontrolled asthma is a condition that can directly impact patients' quality of life and be associated with non-adherence to treatment and errors in inhalation technique. It is known that pharmaceutical monitoring contributes positively to asthma control. Thus, 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). For both groups, the Asthma Control Test (ACT), the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), and treatment adherence questionnaire will be administered by phone at the beginning of month 1 and at the end of month 3, by a blinded researcher in the study. 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. To achieve this, a sample size of 50 individuals (25 for each group) was calculated to test for a difference between the percentages of controlled asthma (ACT > 20) at the end of 3 months between the Pharmaceutical Intervention and Control groups. With an additional 30% for possible losses and refusals, this number should be 56. The calculation considered a power of 80%, a significance level of 5%, and percentages of 50% and 10%, respectively. This study is expected to generate scientific evidence on the effectiveness of pharmaceutical intervention in asthma control and guide public policies within the Unified Health System (SUS).

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paulo Dalcin, Doctor; Phone Number: 555133422439; Email: pdalcin@hcpa.edu.br
• Study Contact Backup: Name: Aline Nogare, Master; Phone Number: 555133422439; Email: anogare@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Paulo de Tarso Roth Dalcin, Doctor
      • Contact: Aline de Lima Nogare, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; With health education	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.
No Intervention: control; Without health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of adherence to treatment	Treatment adherence will be measured through self-reported adherence, using a questionnaire employed in a study involving asthmatic patients as a reference. The adherence score will be defined as a score above 5 points or below 5 points. High adherence will be indicated when the reported use of devices containing corticosteroids is 5 or more times per week, while low adherence will be considered when it is less than 5 times per week.	3 years
Asthma Quality of Life Questionnaire	The quality of life will be assessed using The Asthma Quality of Life Questionnaire (AQLQ). The overall score of the questionnaire is the arithmetic mean of all items, with a minimum score of 1 and a maximum of 7 points. Higher scores would indicate better quality of life in relation to asthma.	3 years
Lung function (spirometry)	The spirometry used for the diagnosis of asthma will be obtained through a review of the patient's medical records or by query. The baseline spirometry for the study will be the one conducted during the routine medical consultation, also obtained through a review of medical records or by query. The study will include a spirometry test at the end of the 3 months, after the pharmaceutical interventions, to be requested by the research team. Spirometry tests are routinely performed in the Pulmonary Physiology Unit of the Pneumology Service at HCPA. Pneumologia do HCPA.	3 years
Rates of exacerbations requiring oral corticosteroid use	Clinical and demographic data will be recorded upon request through queries. For those that cannot be collected through queries, the information will be obtained directly from the medical records or gathered during the initial evaluation.	3 years
Emergency room visits for asthma	Clinical and demographic data will be recorded upon request through queries. For those that cannot be collected through queries, the information will be obtained directly from the medical records or gathered during the initial evaluation.	3 years
Hospital admissions due to asthma	Clinical and demographic data will be recorded upon request through queries. For those that cannot be collected through queries, the information will be obtained directly from the medical records or gathered during the initial evaluation.	3 years

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Paulo Dalcin, Hospital Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 20230013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No