Clinical trial NCT06227793: Pragmatic Clinical Trial to Assess the Effectiveness of Pharmaceutical Intervention in Patients With Uncontrolled Asthma
Official title: Pragmatic Clinical Trial to Assess the Effectiveness of Pharmaceutical Intervention in Patients With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma control
timeFrame: 3 years
Secondary outcomes:
measure: Degree of adherence to treatment
timeFrame: 3 years
measure: Asthma Quality of Life Questionnaire
timeFrame: 3 years
measure: Lung function (spirometry)
timeFrame: 3 years
measure: Rates of exacerbations requiring oral corticosteroid use
timeFrame: 3 years
measure: Emergency room visits for asthma
timeFrame: 3 years
measure: Hospital admissions due to asthma
timeFrame: 3 years
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital Clínicas de Porto Alegre
name: Paulo Dalcin
role: PRINCIPAL_INVESTIGATOR
References: