Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320119
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-13
Brief Title:
Setting a PERSONalized Outcome in ASthma the PERSONAS Study A Patient Driven Outcome PDO Study
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Setting a PERSONalized Outcome in ASthma the PERSONAS Study A Patient Driven Outcome PDO Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSONAS
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 ie 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 ie forced expiratory volume in one second - FEV1 use of rescue therapy night awakeness will also be assessed
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 ie 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 ie forced expiratory volume in one second - FEV1 use of rescue therapy night awakeness will also be assessed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None