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.
Condition: HIV-1 Infection
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Growing evidence in the scientific literature suggests an increased prevalence of long-term
      comorbidities associated with antiretroviral treatment and the infection itself compared with
      noninfected controls of the same age. In addition, aging could manifest 10 years earlier with
      respect to the general population.

      As a result, HIV infection is an increasingly complex chronic disease associated with
      numerous medical, psychological, and social problems that require the attention and
      experience of a wide range of health specialists.

      Information and communications technologies are a strategic element in improving health and
      ensuring a quality, modern, and sustainable health system. The development of mobile devices
      such as smartphones and tablets has shown how mobile applications (apps) have revolutionized
      health care (medical apps). Information and communications technologies could prove very
      useful in the care of patients with chronic conditions, such as diabetes, obesity, and
      cardiovascular disease. They could also play a role in the prevention of comorbid conditions.

      Considering that HIV infection is a chronic disease, our objective was to determine the
      usefulness of an app designed specifically for HIV-infected patients aged ≥60 years. To do
      so, we evaluated the usability of the application in this population and assessed changes in
      patient satisfaction with and quality of health care.

      Since we did not know how familiarized this population was with mobile apps, we set a dual
      main objective: 1) before the clinical trial, participants completed an 8-item survey to
      determine their interest in medical apps and thus determine appropriate sections of interest;
      2) to determine the usability of a specific app among HIV-infected patients aged ≥60 years by
      assessing, at week 24, the percentage of subjects randomized to the app who used the app on
      more than 10 different days after baseline. A final analysis was performed at week 48 to
      determine usability at the end of the study.

      The secondary objectives were as follows: 1) to identify the most frequently used items in
      the app by comparing the items used with those that the patients mentioned in a survey at
      week 48; 2) to compare the number of visits to the HIV Unit in each group (app and controls);
      3) to compare patient satisfaction in the app group by means of an ad hoc test ranging from 1
      (worst) to 5 (best) between baseline and week 48; 4) to compare the groups by assessing
      adherence (SERAD), quality of life (MOS), and a series of clinical parameters at week 48.
    

Intervention name(s): Mobile application
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: APP, old