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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Azienda ospedaliera Spedali Civili di Brescia
RECRUITING
Brescia
Ospedale San Martino di Genova
RECRUITING
Genova
ASST Fate Bene e Fratelli Sacco
RECRUITING
Milan
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
ASST Santi Paolo e Carlo
RECRUITING
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
RECRUITING
Milan
Policlinico San Matteo
RECRUITING
Pavia
Ospedale di Rovigo
RECRUITING
Rovigo
Humanitas Hospital - UO Allergologia
RECRUITING
Rozzano
Humanitas Hospital - UO Pneumologia
NOT_YET_RECRUITING
Rozzano
Istituti Clinici Scientifici Maugeri, IRCCS Tradate
RECRUITING
Tradate
Contact Information
Primary
Francesco Blasi, Prof.
francesco.blasi@unimi.it
+390250320627
Backup
Maura Spotti, PhD
maura.spotti@policlinico.mi.it
+393336216405
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 190
Treatments
Experimental: Personal approach on asthma control (PDO group)
No_intervention: Non-personalized approach (UC group)
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov