Pilot Study to Assess the Impact of a Mobile Health Application (App) on Clinical Outcomes and Satisfaction of Older HIV-Infected Patients, as an Emerging Tool for Care, Education and Prevention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The number of clinical events or comorbidities between the 2 groups
研究概览
简要总结
In recent years, HIV care has been reframed by the concepts of the HIV care and prevention. The success of these strategies will depend on integrated prevention and care system and sustained behavioral modification. The HIV infection is a chronic disease and the improved survival in HIV patients favours the emergence of new long-term morbidities associated with treatment and/or the virus itself. In high-income countries, approximately 30% of all adults living with HIV are aged 50 years and over. In 2015, 50% of HIV-infected patients will be over 50 years of age. Health plans are a priority to prevent this accelerated and accentuated process.
The development of mobile devices such as smartphones and tablet computers has spurred rapid growth in the field of mobile health, the use of mobile-enabled applications that collect or deliver health care information and data. These applications offer the potential for dynamic engagement of patients and providers in health care and a new means of improving health outcomes. This technology could have profound application in the prevention or in the treatment of patients with chronic disease such as diabetes, obesity, HIV, etc, since these diseases are generating more health spending worldwide. The rapid growth in health has outpaced the needed to validate the clinical effectiveness of these applications. For this reason, we propose a study to assess the benefit of a specific App on the management of HIV-infected population aged 60 years or older It is a Randomized clinical trial, including 2 groups: 1) an experimental group comprising patients using the app + routine medical care and 2) a control group. The usability of the app and patient satisfaction were evaluated in the app group at weeks 24 and 48. Quality of life, adherence to treatment, and clinical parameters were compared in both groups at 48 weeks.
详细描述
Aging is the term used to describe the progressive loss of physical ability, changes in appearance, and/or decrease in mental agility that we experience over time. This process advances at different rates as a consequence of genetic and environmental factors.
Aging of the population can be considered a success of public health policies and socioeconomic development, although it also constitutes a challenge for society, which must adapt in order to improve the health and functional capacity of the elderly, as well as their social participation and their safety.
However, a recent major study on health and aging warned that the burden of chronic disease will considerably affect quality of life in aging patients.
The increase in the average age worldwide makes chronic diseases and the consequent reduction in well-being a prominent global public health challenge. One of the greatest challenges for a national health system is to achieve sustained care of people with chronic health problems (both physical and psychological).
HIV infection is a chronic disease. However, the life expectancy of affected patients has increased considerably thanks to advances in antiretroviral treatment. In 2015, around 50% of HIV-infected patients were ≥50 years old. It is estimated that by 2030, around 70% of the HIV-infected population in the United States of America will be aged ≥50 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected patients (≥60 years).
- •Patients in antiretroviral treatment
- •Patients who have and are used to a smartphone
- •Patient who agree to participate in the study and signed informed consent
排除标准
- •Patients with conditions that hampered understanding and use of mobile applications
结局指标
主要结局
The number of clinical events or comorbidities between the 2 groups
时间窗: from baseline to week 48
change in bone mineral density Prevention
时间窗: from baseline to week 48
(BMD, lumbar and hip T-scores and Z-scores) measured by DXA scan.
次要结局
- adherence(From baseline to Week 48)
- Changes in FRAX equation.(From baseline to week48)
- Identify the most frequently used items in the app(From baseline to week 48)
- To compare patient satisfaction in the app group(Since baseline to week 48)
- Usability of App(Since baseline to week 48)
- Quality of life (Global, physical, mental and social)(From baseline to Week 48)