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.

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.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Other: Mobile application

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08018
      • Hospital Germans Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

- Patients with conditions that hampered understanding and use of mobile applications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HIV-subjects with APP; HIV-infected patients using the App + standard clinical management (SCM)	Other: Mobile application
NO_INTERVENTION: Control group; HIV-infected patients, who only receive Standard Clinical Management (without the App)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of clinical events or comorbidities between the 2 groups		from baseline to week 48
change in bone mineral density Prevention	(BMD, lumbar and hip T-scores and Z-scores) measured by DXA scan.	from baseline to week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare patient satisfaction in the app group	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	Since baseline to week 48
Usability of App	• 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.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.	Since baseline to week 48
Identify the most frequently used items in the app	comparing the items used with those that the patients mentioned in a survey at week 48. We use a linkert Scale: minimum and maximum values: 1 low satisfied-5 higly satisfied	From baseline to week 48
Quality of life (Global, physical, mental and social)	compare the groups by assessing quality of life (Medical Outcomes Study-HIV Health Survey) with a questionnaire. 4 qualitative categories ( Global, physical, mental and social).: minimum and maximum values: very poor qualitiy of life; poor quality of life; good quality of life; very good quality of life.	From baseline to Week 48
adherence	compare the groups by assessing quality of life (SERAD test)	From baseline to Week 48
Changes in FRAX equation.		From baseline to week48

Other Outcome Measures

Outcome Measure	Time Frame
Changes in blood pressure,	From baseline to week48
Changes in glycemia	From baseline to week48
Changes in weight	The number of clinical visits at the HIV unit, and hospitalizations.
Changes in exercise	From baseline to week48
Changes in smoking habit	From baseline to week48
The number and severity of antiretroviral-related adverse events	From baseline to week48
The number of clinical visits at the HIV unit, and hospitalizations.	From baseline to week48

Collaborators and Investigators

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Investigators: Principal Investigator: EUGÈNIA NEGREDO, PhD, MD, Germans Trias I Pujol Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2016
• Primary Completion (ACTUAL): July 3, 2018
• Study Completion (ACTUAL): July 3, 2018

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (ACTUAL): October 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: APP, old
• Other Study ID Numbers: APP-Age

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No