HIV InfectionNCT01117675
A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care
A study testing Virtual Hospital in people with HIV Infection, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Background: Antiretroviral therapy has changed the natural history of the HIV infection in developed countries becoming a chronic disease. This clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Virtual Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Dec 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable patients (CD4 >250 cells/mm3 during at least the 3 months before inclusion to the study)
- Having access to a computer and to a broadband
Who cannot join
- HIV infected adults with current therapy failure (defined by detectable viral load on treatment or CD4 cell count < 250 cells/ml)
- Tumors
- Opportunistic infections
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Background: Antiretroviral therapy has changed the natural history of the HIV infection in developed countries becoming a chronic disease. This clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. A new home care model using a telemedicine system (Virtual Hospital) was developed.
Read the detailed description
Stable HIV-infected patients with access to a computer and broadband were randomized to: arm I, patients monitored by Virtual Hospital the first year and arm II patients monitored in the hospital the first year (standard of care). After 1 year of follow up, patients were crossed into the other arm. A "Virtual Hospital" was developed to integrate the control of patient in a multidisciplinary telecare team, allowing the patient to be remotely followed-up by the healthcare professionals through Internet. Virtual Hospital had four main services: Virtual Consultations, Telepharmacy, Virtual Library and Virtual Community. A technical and a clinical evaluation of Virtual Hospital were made.
- Conditions
- HIV Infection
- Being tested
- Virtual Hospital, Standard of Care
- Keywords
- Telemedicine, Home care, Chronic HIV infection, HIV-infected patients
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual HospitalOther
A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Other | Arm I: HIV-infected patients controlled through Virtual Hospital Receives: Other: Virtual Hospital |
| Arm II | Other | Arm II: HIV-infected patients controlled through Standard Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of patients cared through Virtual Hospital
The main goals were the definition, development, clinical routine installation and evaluation of a telemedicine service that compares standard care with telecare follow-up for attending stable HIV-infected patients in the chronic phase of their disease.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117675
- Sponsor's protocol ID
- Hospital Clinic
- Other IDs
- Universidad Politecnica Madrid
- Status last verified
- Apr 2010
- First submitted
- 3 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Caceres C, et al. A telemedicine system for chronic HIV/AIDS patient home care through the Internet. Telemedicine and e-Health 2005; 11: 219-220. Caceres C, et al. A Home Integral Telecare System for HIV/AIDS Patients. Stud Health Technol Inform. 2005;114:23-9. Caceres C, et al. An integral care telemedicine system for HIV/AIDS patients. Int J Med Inform. 2006; 75:638-42.
Leon A, Caceres C, Fernandez E, Chausa P, Martin M, Codina C, Rousaud A, Blanch J, Mallolas J, Martinez E, Blanco JL, Laguno M, Larrousse M, Milinkovic A, Zamora L, Canal N, Miro JM, Gatell JM, Gomez EJ, Garcia F. A new multidisciplinary home care telemedicine system to monitor stable chronic human immunodeficiency virus-infected patients: a randomized study. PLoS One. 2011 Jan 21;6(1):e14515. doi: 10.1371/journal.pone.0014515.
PubMed 21283736
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care
- ClinicalTrials.gov ID
- NCT01117675
- Acronym / sponsor ID
- Hospital Clinic
- Conditions
- HIV Infection
- Keywords
- Telemedicine, Home care, Chronic HIV infection, HIV-infected patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 May 2010 (estimated)
- 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.
Background: Antiretroviral therapy has changed the natural history of the HIV infection in developed countries becoming a chronic disease. This clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. A new home care model using a telemedicine system (Virtual Hospital) was developed.
Detailed description
Stable HIV-infected patients with access to a computer and broadband were randomized to: arm I, patients monitored by Virtual Hospital the first year and arm II patients monitored in the hospital the first year (standard of care). After 1 year of follow up, patients were crossed into the other arm. A "Virtual Hospital" was developed to integrate the control of patient in a multidisciplinary telecare team, allowing the patient to be remotely followed-up by the healthcare professionals through Internet. Virtual Hospital had four main services: Virtual Consultations, Telepharmacy, Virtual Library and Virtual Community. A technical and a clinical evaluation of Virtual Hospital were made.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Other | Other: Virtual HospitalArm I: HIV-infected patients controlled through Virtual Hospital |
| Arm II | Other | Other: Standard of CareArm II: HIV-infected patients controlled through Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable patients (CD4 >250 cells/mm3 during at least the 3 months before inclusion to the study)
- Having access to a computer and to a broadband
Key exclusion criteria (4 listed)
- HIV infected adults with current therapy failure (defined by detectable viral load on treatment or CD4 cell count < 250 cells/ml)
- Tumors
- Opportunistic infections
- Pregnant women
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 |
|---|---|---|
| Virtual HospitalA new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients | Other | Arm I |
| Standard of CareStandard of Care | Other | Arm II |
Primary outcome
Clinical evaluation of patients cared through Virtual Hospital
Time frame: Two years
The main goals were the definition, development, clinical routine installation and evaluation of a telemedicine service that compares standard care with telecare follow-up for attending stable HIV-infected patients in the chronic phase of their disease.
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 5 May 2010.
- BackgroundCaceres C, et al. A telemedicine system for chronic HIV/AIDS patient home care through the Internet. Telemedicine and e-Health 2005; 11: 219-220. Caceres C, et al. A Home Integral Telecare System for HIV/AIDS Patients. Stud Health Technol Inform. 2005;114:23-9. Caceres C, et al. An integral care telemedicine system for HIV/AIDS patients. Int J Med Inform. 2006; 75:638-42.
- Derived from this study: PubMed 21283736Leon A, Caceres C, Fernandez E, Chausa P, Martin M, Codina C, Rousaud A, Blanch J, Mallolas J, Martinez E, Blanco JL, Laguno M, Larrousse M, Milinkovic A, Zamora L, Canal N, Miro JM, Gatell JM, Gomez EJ, Garcia F. A new multidisciplinary home care telemedicine system to monitor stable chronic human immunodeficiency virus-infected patients: a randomized study. PLoS One. 2011 Jan 21;6(1):e14515. doi: 10.1371/journal.pone.0014515.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Hospital in people with HIV Infection, run by Hospital Clinic of Barcelona 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 2 inclusion and 4 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 5 May 2010. 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?
Clinical evaluation of patients cared through Virtual Hospital (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117675, which also lists 2 linked publications.
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 5 May 2010; AzTrials last refreshed its copy on 8 Nov 2026.