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

NCT06320119 | Recruiting

• 1 other identifier: 2943
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• 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).

  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). Primary outcome will be measured at month 3 by asthma control test (ACT).

  Primary outcome will be measured at month 3 by asthma control test (ACT).

Secondary Outcomes (8)

• 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.

  from month 3 to month 6

• 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.

  from baseline to month 3

• 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.

  from month 3 to month 6;

• 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.

  from baseline to month 3

• 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.

  from month 3 to month 6

Study Arms (2)

Personal approach on asthma control (PDO group)

EXPERIMENTAL

Other: PDO Group

Non-personalized approach (UC group)

NO INTERVENTION

Interventions

PDO Group OTHER

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

Personal approach on asthma control (PDO group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (12)

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

RECRUITING

Azienda ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Ospedale San Martino di Genova

Genova, 16132, Italy

RECRUITING

ASST Fate Bene e Fratelli Sacco

Milan, 20100, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20100, Italy

NOT YET RECRUITING

ASST Santi Paolo e Carlo

Milan, 20100, Italy

RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

Milan, 20122, Italy

RECRUITING

Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Ospedale di Rovigo

Rovigo, 45100, Italy

RECRUITING

Humanitas Hospital - UO Allergologia

Rozzano, 20089, Italy

RECRUITING

Humanitas Hospital - UO Pneumologia

Rozzano, 20089, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri, IRCCS Tradate

Tradate, 21049, Italy

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Francesco Blasi, Prof.

CONTACT

+390250320627; francesco.blasi@unimi.it

Maura Spotti, PhD

CONTACT

+393336216405; maura.spotti@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: January 1, 2023
• Primary Completion: January 15, 2025
• Study Completion: September 30, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-03

Locations

IT (12)