跳至主要内容
临床试验/NCT06563284
NCT06563284已完成不适用

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

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Effective use of the mobile application

研究概览

简要总结

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

详细描述

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 patient's 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • HIV-infected patients
  • HIV plasma RNA values < 50 copies/mL
  • Patients referred to the HIV outpatient clinic at the SC Infectious Diseases of the Azienda Alexandria Hospital
  • Patients on a stable antiretroviral regimen for at least 6 months
  • Patients who have the ability to download the application under study
  • Patients who have signed the informed consent

排除标准

  • Newly diagnosed patients

结局指标

主要结局

Effective use of the mobile application

时间窗: 6 months

Frequency of interaction with the mobile application

次要结局

  • Generalized Anxiety Disorder 7(Twice, at baseline and after 4 months)
  • Pittsburgh Sleep Quality index(Twice, at baseline and after 4 months)
  • Adherence to therapy(Everyday, through study completion (6 months))
  • EuroQol five-dimensional questionnaire(Twice, at baseline and after 4 months)

研究者

发起方
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

HealthcAre sUppoRt fOr Remote HIV pAtients | 临床试验