RecruitingNot ApplicableNCT06320119

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


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

190 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called PERSONAS — helps patients with mild to moderate asthma in Italy set their own personal health goals for treatment, rather than relying solely on standard medical measurements. The aim is to understand what matters most to individual patients and whether a patient-driven approach leads to better asthma management. **You may be eligible if...** - You are 18 years or older - You have a documented diagnosis of mild to moderate asthma for at least 6 months - You are currently using a long-acting inhaler combining a bronchodilator and a steroid - Your asthma control test (ACT) score is below 20, meaning your asthma is not well controlled - You do not smoke, or you stopped at least 1 year ago (with a modest smoking history) - You can read and understand Italian **You may NOT be eligible if...** - You are currently taking oral steroids or a biologic drug for severe asthma - You have other significant lung conditions like COPD - You have had a severe asthma attack requiring hospitalization in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPDO Group

Patients in the intervention gruop with set a personalized outcome within a usual asthma review consultation


Locations(12)

ASST Papa Giovanni XXIII

Bergamo, Italy

Azienda ospedaliera Spedali Civili di Brescia

Brescia, Italy

Ospedale San Martino di Genova

Genova, Italy

Policlinico San Matteo

Pavia, Italy

Ospedale di Rovigo

Rovigo, Italy

Humanitas Hospital - UO Allergologia

Rozzano, Italy

Humanitas Hospital - UO Pneumologia

Rozzano, Italy

Istituti Clinici Scientifici Maugeri, IRCCS Tradate

Tradate, Italy

ASST Fate Bene e Fratelli Sacco

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

ASST Santi Paolo e Carlo

Milan, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

Milan, Italy

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NCT06320119


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