Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563284
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
HealthcAre sUppoRt fOr Remote HIV pAtients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HealthcAre sUppoRt fOr Remote HIV pAtients Use of an App to Support HIV Patients to Ensure Continuity of Care and Assess Its Impact on Therapy Adherence and Quality of Life
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AURORA
Brief Summary:
Adherence to antiretroviral therapy ART is crucial for treatment success in HIV patients This study proposes the use of a smartphone application specifically developed for this project to monitor ART adherence and assess quality of life among HIV patients The aim is to optimize long-term disease management through the early identification of comorbidities and clinical complications
Detailed Description:
Since the first cases were reported more than 35 years ago 78 million people have been infected with HIV and 35 million have died from AIDS-related illnesses
Currently the availability of TARV regimens associated with good tolerability and high levels of efficacy make it necessary to turn attention toward new standards of efficacy indicative of patients mental and physical well-being Indeed health-related quality of life HRQoL is becoming increasingly preponderant as a therapeutic outcome Despite TARV-related viroimmunologic success people living with HIV PLWH continue to have lower HRQoL than the general population Indeed much evidence confirms the impact on quality of life not only of therapeutic treatments but also of social and relationship issues and comorbidities Improving HRQoL is now therefore a primary goal for the care and support of PLWH
Evaluations of new treatments and interventions to improve care therefore require the measurement in addition to clinical endpoints of HRQoL using valid and reliable instruments Therefore the importance of PROs Patient Reported Outcomes which represent the description of the patients own reported state of health without any interpretation by clinicians or health care personnel emerges in this area In this way the patient is directly involved in his or her own process of care
Adherence to TARV is essential for successful treatment and improved quality of life Unfortunately non-adherence to treatment is a common problem among HIV-infected patients
The Covid-19 emergence has significantly revolutionized the health care system leading to the implementation of new modes of care including the use of technological tools to ensure remote medical care
The present study targeting HIV-infected patients undergoing virological suppression aims to use a smartphone application to facilitate continuity of care remotely promoting adherence to therapy and thus the effectiveness of TARV assessing the patients quality of life and identifying possible comorbidities or other critical clinical
Currently the availability of TARV regimens associated with good tolerability and high levels of efficacy make it necessary to turn attention toward new standards of efficacy indicative of patients mental and physical well-being Indeed health-related quality of life HRQoL is becoming increasingly preponderant as a therapeutic outcome Despite TARV-related viroimmunologic success people living with HIV PLWH continue to have lower HRQoL than the general population Indeed much evidence confirms the impact on quality of life not only of therapeutic treatments but also of social and relationship issues and comorbidities Improving HRQoL is now therefore a primary goal for the care and support of PLWH
Evaluations of new treatments and interventions to improve care therefore require the measurement in addition to clinical endpoints of HRQoL using valid and reliable instruments Therefore the importance of PROs Patient Reported Outcomes which represent the description of the patients own reported state of health without any interpretation by clinicians or health care personnel emerges in this area In this way the patient is directly involved in his or her own process of care
Adherence to TARV is essential for successful treatment and improved quality of life Unfortunately non-adherence to treatment is a common problem among HIV-infected patients
The Covid-19 emergence has significantly revolutionized the health care system leading to the implementation of new modes of care including the use of technological tools to ensure remote medical care
The present study targeting HIV-infected patients undergoing virological suppression aims to use a smartphone application to facilitate continuity of care remotely promoting adherence to therapy and thus the effectiveness of TARV assessing the patients quality of life and identifying possible comorbidities or other critical clinical
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None