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AzTrials

HIV-1 InfectionNCT04137016

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.

A study testing Mobile application in people with HIV-1 Infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 99 years
Conditions the study is for
HIV-1 Infection
What is being tested?
Mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
15 Dec 2016to 3 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08018

Other trials in Spain

About this study

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.

Read the 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.

Conditions
HIV-1 Infection
Being tested
Mobile application
Keywords
APP, old
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile applicationOther

Study groups in NCT04137016
Study groupRoleWhat they receive
HIV-subjects with APPExperimentalHIV-infected patients using the App + standard clinical management (SCM)
Receives: Other: Mobile application
Control groupNo interventionHIV-infected patients, who only receive Standard Clinical Management (without the App)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of clinical events or comorbidities between the 2 groups

    Measured: from baseline to week 48

  2. change in bone mineral density Prevention

    (BMD, lumbar and hip T-scores and Z-scores) measured by DXA scan.

    Measured: from baseline to week 48

Secondary outcomes (6)
  1. 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

    Measured: Since baseline to week 48

  2. 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.

    Measured: Since baseline to week 48

  3. 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

    Measured: From baseline to week 48

  4. 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.

    Measured: From baseline to Week 48

  5. adherence

    compare the groups by assessing quality of life (SERAD test)

    Measured: From baseline to Week 48

  6. Changes in FRAX equation.

    Measured: From baseline to week48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start15 Dec 2016
  3. Primary completion3 Jul 2018
  4. Study completion3 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137016
Sponsor's protocol ID
APP-Age
Status last verified
Oct 2019
First submitted
17 Oct 2019
Last updated
6 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobile application in people with HIV-1 Infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of clinical events or comorbidities between the 2 groups (time frame: from baseline to week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.

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