protocolSection identificationModule nctId: NCT06320119, orgStudyIdInfo id: 2943, briefTitle: Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study, acronym: PERSONAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bronchial Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: PDO Group, outcomesModule primaryOutcomes measure: Primary Outcome. The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group)., secondaryOutcomes measure: Secondary Outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6., secondaryOutcomes measure: Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1., secondaryOutcomes measure: Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1., secondaryOutcomes measure: Secondary outcome. To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST Papa Giovanni XXIII, status: RECRUITING, city: Bergamo, zip: 24127, country: Italy, contacts name: Fabiano Di Marco, Prof., role: CONTACT, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Azienda ospedaliera Spedali Civili di Brescia, status: RECRUITING, city: Brescia, zip: 25123, country: Italy, contacts name: Laura Pini, Prof., role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale San Martino di Genova, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Fulvio Braido, Prof., role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, status: RECRUITING, city: Milano, zip: 20122, country: Italy, contacts name: Francesco Blasi, Prof., role: CONTACT, phone: +390250320627, email: francesco.blasi@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Fate Bene e Fratelli Sacco, status: RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Pierachille Santus, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Grande Ospedale Metropolitano Niguarda, status: NOT_YET_RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Paolo Tarsia, Prof., role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Santi Paolo e Carlo, status: RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Stefano Centanni, Prof., role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico San Matteo, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Angelo Corsico, Prof., role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale di Rovigo, status: RECRUITING, city: Rovigo, zip: 45100, country: Italy, contacts name: Gianluca Casoni, Dott., role: CONTACT, geoPoint lat: 45.06982, lon: 11.79022, locations facility: Humanitas Hospital - UO Allergologia, status: RECRUITING, city: Rozzano, zip: 20089, country: Italy, contacts name: Enrico Heffler, role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Humanitas Hospital - UO Pneumologia, status: NOT_YET_RECRUITING, city: Rozzano, zip: 20089, country: Italy, contacts name: Stefano Aliberti, Prof., role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Istituti Clinici Scientifici Maugeri, IRCCS Tradate, status: RECRUITING, city: Tradate, zip: 21049, country: Italy, contacts name: Antonio Spanevello, Prof., role: CONTACT, geoPoint lat: 45.70843, lon: 8.90763, hasResults: False