Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Bronchial Asthma

Treatments

Other: PDO Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06320119

2943

Details and patient eligibility

About

To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.

The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).

This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed.

Enrollment

190 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients aged ≥18 years;
Patients with a documented diagnosis of mild/moderate asthma, according to GINA, for at least 6 months before visit 1;
Patients on LABA/ICS chronic inhaled treatment (> 4 weeks before visit 1);
ACT values <20 points
No smoking patients, or former smokers (at least 1 year since quitting smoking, and no more than 10 pack/year, according the WHO definition);
Patients able to set up a personal outcome according to the protocol instruction, and willing to improve their personal outcome;
Patients able to understand written and spoken Italian;
Patients who give their informed consent to participate in the study.

Exclusion criteria

Patients treated with oral corticosteroids (OCS) and/or biological for severe refractory asthma;
Patients treated with OCS for any other chronic disease;
Subjects with current evidence of chronic obstructive pulmonary disease (COPD), pneumonia, active tuberculosis, active lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or respiratory abnormalities other than asthma;
Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.