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.
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.
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 group | Role | What they receive |
|---|---|---|
| HIV-subjects with APP | Experimental | HIV-infected patients using the App + standard clinical management (SCM) Receives: Other: Mobile application |
| Control group | No intervention | HIV-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.
The number of clinical events or comorbidities between the 2 groups
Measured: from baseline to week 48
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)
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
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
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
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
adherence
compare the groups by assessing quality of life (SERAD test)
Measured: From baseline to Week 48
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.
- First posted23 Oct 2019
- Study start15 Dec 2016
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EUGÈNIA NEGREDO, PhD, MD, Principal investigator, Germans Trias i Pujol Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04137016
- Acronym / sponsor ID
- APP-Age
- Conditions
- HIV-1 Infection
- Keywords
- APP, old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-subjects with APP | Experimental | Other: Mobile applicationHIV-infected patients using the App + standard clinical management (SCM) |
| Control group | No intervention | –HIV-infected patients, who only receive Standard Clinical Management (without the App) |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with conditions that hampered understanding and use of mobile applications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application | Other | HIV-subjects with APP |
Primary outcome
The number of clinical events or comorbidities between the 2 groups
Time frame: from baseline to week 48
change in bone mineral density Prevention
Time frame: from baseline to week 48
(BMD, lumbar and hip T-scores and Z-scores) measured by DXA scan.
6 secondary outcomes
To compare patient satisfaction in the app group
Time frame: Since baseline to week 48
Usability of App
Time frame: Since baseline to week 48
Identify the most frequently used items in the app
Time frame: From baseline to week 48
Quality of life (Global, physical, mental and social)
Time frame: From baseline to Week 48
adherence
Time frame: From baseline to Week 48
Changes in FRAX equation.
Time frame: From baseline to week48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EUGÈNIA NEGREDO, PhD, MD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
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.